Japan Device Approvals
Japan's regulator, PMDA, also approves medical devices, and many reach Japan after the US, which Japan calls device lag. This is every new device PMDA approved since 2007, with the US approval date where PMDA lists one.
1,521 medical device approvals from Japan's regulator (PMDA), April 2007 to Dec 24, 2025: 981 new devices and 540 changes to approved ones. PMDA lists the US approval date for many, so you can see how far Japan runs behind.
- New devices, last 12 months: 58
- Approved in the US first, last 5 years: 45%
- Median lag when US first: 38 months
- Median review, last 5 years: 270 days
- Newest in PMDA's list: Dec 24, 2025
New Devices per Year
Approved in Japan, 2008 to Dec 24, 2025.
Median Review Time
Days from application to approval, new devices, by year of approval.
New Devices by Area
PMDA review team, 2021 to 2025.
- Heart and circulation54
- Brain, lungs and nervous system48
- Robotics, software and other46
- Eye, ear, nose and throat38
- Orthopedics and plastic surgery22
- Digestive, urinary and reproductive14
- Dental3
Newest Approvals
The last two years, new devices and changes such as a new use.| Dec 24, 2025 | Digital Biomarker DNP-ASSoftware for general- purpose phonocardiograph | AMI Inc. | New device | Not listed | — | 456 days | The application was submitted for marketing approval of a software for general-purpose phonocardiograph used to analyze information on heart sounds and electrocardiograms provided by the general-purpose phonocardiograph and estimates whether or not aortic valve stenosis is moderate or more severe. The product is intended to be used to assist in making the decision to perform ultrasoundcardiography. |
| Dec 22, 2025 | PillCam SB3 Capsule Endoscopy SystemCapsule imaging and tracking device | Covidien Japan Inc. | Change | Aug 27, 2021K211684 | 52 mo later | 187 days | A capsule imaging and tracking device is intended to take images of small intestinal mucosa and provide the images for diagnosis of small intestine diseases. This application was submitted for a software update to improve the feature to delete images of low significance and to support the new OS due to the end of the old OS support (A "partial change" application). |
| Dec 19, 2025 | remede SystemImplantable phrenic nerve electrical stimulator | Zoll Respicardia, Inc. | New device | Oct 2017P160039 | 98 mo later | 1793 days | An implantable phrenic nerve electrical stimulator designed to induce diaphragm contraction through transvenous phrenic nerve stimulation in adult patients with moderate to severe central sleep apnea who are ineligible for, or intolerant to, positive pressure ventilation and oxygen therapy. This product consists of an implantable stimulator for implanting under the clavicle, a lead for detection of respiration and stimulation, a delivery system used for implantation of the lead, and other components. |
| Dec 19, 2025 | PHIL SystemCentral circulatory intravascular embolization prosthesis | Terumo Corporation | New device | Dec 31, 2025 | Same month | 267 days | A central circulatory intravascular embolization prosthesis is used for vascular embolization before surgical resection of cerebral arteriovenous malformation that requires surgical treatment, or for vascular embolization of dural arteriovenous fistula that is difficult to treat curatively with transvenous embolization, radiation therapy and surgical treatment. |
| Dec 19, 2025 | PillCam COLON 2 Capsule Endoscopy SystemCapsule imaging and tracking device | Covidien Japan Inc. | Change | Jan 14, 2016K153466 | 119 mo later | 242 days | A capsule imaging and tracking device is intended to take images of colorectal mucosa and provide the images when colonoscopy is required for diagnosis of colonic diseases but it is difficult to be performed. This application was submitted for a software update to improve the feature to delete images of low significance and to support the new OS due to the end of the old OS support (A "partial change" application). |
| Dec 19, 2025 | Precision 7Reusable colored vision corrective contact lens | Alcon Japan Ltd. | New device | Dec 2, 2021 | 49 mo later | 266 days | This application was submitted for marketing approval of a reusable colored vision corrective contact lens for daily wear and continuous wear (for a maximum of 1 week). The lens is composed of silicone hydrogel with a water - content of 55% and oxygen permeability (Dk) of 119 × 10 11 2 /sec)•(mLO (cm /(mL×mmHg)). 2 |
| Dec 15, 2025 | Rezum SystemWater vapour delivery system for prostatic tissue | Boston Scientific Japan K.K. | Change | Not listed | — | 76 days | A water vapour delivery system for prostatic tissue used to reduce prostatic tissue involved in prostatic hyperplasia and relieve symptoms and obstruction. The application was submitted mainly to add a generator with an improved user interface for better usability. (A “partial change” application submitted during the post- market performance review period) |
| Dec 15, 2025 | FARASTAR ConsolePercutaneous cardiac coagulation/ablation electrosurgical unit | Boston Scientific Japan K.K. | Change | Sep 24, 2025 | 3 mo later | 109 days | A pulse generator for pulsed field ablation procedures used for the treatment of arrhythmia. The application was submitted to add a console type and an interconnection box for accessories. (A “partial change” application submitted during the post- market performance review period) |
| Dec 9, 2025 | EmbosphereCentral circulatory intravascular embolization prosthesis | Merit Medical Japan K.K. | Change | Not listed | — | 361 days | A central circulatory intravascular embolization prosthesis used for arterial embolization in patients with hypervascular tumors or arteriovenous malformation. The application was submitted to add the indication for arterial embolization in patients with polycystic liver disease or polycystic kidney disease (A "partial change" application). |
| Dec 5, 2025 | SeQuent Please Ph Drug Eluting Balloon CatheterCatheter for balloon dilatation angioplasty | Nipro Corporation | New device | Not listed | — | 995 days | A Catheter for balloon dilatation angioplasty is used for percutaneous transluminal angioplasty in patients who have de novo, restenosis, or in-stent restenosis lesions with a length of 50 mm or greater to 200 mm or less in the superficial femoral artery and popliteal artery with a reference vessel diameter of 4.0 mm or greater to 7.0 mm or less. The balloon surface of this product is coated with paclitaxel as a drug. |
| Dec 3, 2025 | SweatWatchSweat lactate monitoring system | Grace Imaging, Inc. | New device | Not listed | — | 636 days | A sweat lactate monitoring system that provides information to set exercise loads by measuring and displaying changes over time in the patient's sweat lactate concentration during exercise. This product consists of a sensor chip, a sensor device, a data display program, and other components. The product was developed as a device to facilitate the implementation of cardiopulmonary exercise testing used in cardiac rehabilitation, etc. |
| Dec 3, 2025 | TightRail FamilyPacemaker/ defibrillator lead extraction kit | Philips Japan, Ltd. | New device | Mar 4, 2015K150360 | 129 mo later | 230 days | The application was submitted for marketing approval of a pacemaker/defibrillator lead extraction kit intended to be used to facilitate extraction of cardiac leads, incorporating a mechanism to expose and rotate a blade from the sheath tip via manipulation of the handle. |
| Nov 26, 2025 | Woven EndoBridge DeviceCentral circulatory intravascular embolization prosthesis | Terumo Corporation | Change | Not listed | — | 336 days | A central circulatory intravascular embolization prosthesis intended to be used for endovascular treatment of wide-necked (defined the size as neck width 4 mm or greater or dome-to-neck ratio less than 2) bifurcation intracranial aneurysms located in anterior or posterior circulation. The application was submitted to add a product type that can be delivered via a catheter with an inner diameter of 0.017 inches in order to improve the operability and safety. (A “partial change” application submitted during the post- market performance review period) |
| Nov 26, 2025 | CT LUCIA 621P Monofocal Intraocular LensHeparin-coated posterior chamber lens | Carl Zeiss Meditec Co., Ltd. | New device | Feb 7, 2023 | 34 mo later | 268 days | This application was submitted for marketing approval of a heparin-coated posterior chamber lens and a posterior chamber lens with inserter, which a monofocal posterior chamber lens is preloaded into an injector, and the lens is intended to be inserted as a substitute for a crystalline lens by implanting in the posterior chamber to correct visual acuity of aphakic eyes. |
| Nov 21, 2025 | VARIPULSE Pulsed Field Ablation CatheterCatheter for cardiac ablation | Johnson & Johnson K.K. | Change | Jun 26, 2025 | 5 mo later | 147 days | A multielectrode catheter is used for conducting pulsed field ablation and cardiac electrophysiological mapping for the treatment of patients with drug-refractory symptomatic paroxysmal atrial fibrillation. The application was submitted to add directions of use such as ablation sites and frequencies based on the results of clinical studies attached at the time of initial approval and to add irrigation flow rate settings during ablation. (A “partial change” application submitted during the post- market performance review period) |
| Nov 19, 2025 | OmniaSecure MRI LeadImplantable defibrillator/ pacemaker electrode/lead | Medtronic Japan Co., Ltd. | New device | Apr 22, 2025 | 7 mo later | 233 days | An implantable defibrillator lead that is connected to an implantable defibrillator and a defibrillator with biventricular pacing function. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The main feature of this product is that the lead diameter is reduced compared with conventional defibrillator leads by removing the lumen for stylet insertion, etc., as with the company's approved pacemaker lead "SelectSecure Lead" (Approval No. 22400BZX00005000). |
| Nov 14, 2025 | RelayPro Thoracic Stent-Graft SystemAortic stent graft | Terumo Corporation | Change | Aug 2021 | 51 mo later | 228 days | An aortic stent graft is used for the treatment of descending thoracic aortic aneurysm or complicated Stanford type B aortic dissection (including dissecting aortic aneurysms). The application was submitted to add the indication for chronic Stanford type B dissection (A "partial change" application). |
| Nov 12, 2025 | UroLift SystemImplantable prostatic tissue retractor system | NeoTract, Inc. | Change | Not listed | — | 61 days | An implantable prostatic tissue retractor system indicated for the treatment of dysuria associated with prostatic hyperplasia. The system is composed of an implant to be placed in the prostate and a delivery device which delivers the implant transurethrally to the prostate. This application was submitted to add a manufacturing site. The application falls under "expedited review of change of manufacturing site" in accordance with "Acceleration of Procedures for Change and Addition of Manufacturing Sites for Medical Devices and In Vitro Diagnostics" (PFSB/ELD/OMDE Notification No. 1119-7 and PFSB/CND Notification No. 1119-12 dated November 19, 2014). (A “partial change” application submitted during the post- market performance review period) |
| Nov 5, 2025 | Apple's Hypertension Notification FeatureSoftware for analysis of home use pulse wave information | Apple Inc. | New device | Sep 11, 2025 | 2 mo later | 211 days | The application was submitted for marketing approval of a software for analysis of home use pulse wave information used to analyze data obtained by photoplethysmography, detect patterns suggestive of hypertension, and notify the user. |
| Oct 31, 2025 | Restylane DefyneHyaluronic acid- containing injectable soft tissue | Galderma KK | New device | Dec 9, 2016 | 107 mo later | 612 days | The application was submitted for marketing approval of a hyaluronic acid-containing injectable soft tissue indicated for injection into the mid to deep dermis for the correction and the improvement of appearance of moderate to severe facial wrinkles (such as nasolabial folds). |
| Oct 31, 2025 | Restylane RefyneHyaluronic acid- containing injectable soft tissue | Galderma KK | New device | Dec 9, 2016 | 107 mo later | 582 days | The application was submitted for marketing approval of a hyaluronic acid-containing injectable soft tissue indicated for injection into the mid to deep dermis for the correction and the improvement of appearance of moderate to severe facial wrinkles (such as nasolabial folds). |
| Oct 24, 2025 | GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | Change | Not listed | — | 98 days | An aortic stent graft system used for the treatment of patients with thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms who are difficult to treat with conventional surgical repair. The application was submitted to add pigments to the raw materials of the sleeve attachment fiber which secures the stent graft sleeve and deployment line, and to change the raw material of the gold marker bands, falling under a "specified partial change" based on "Acceleration of Procedure for Specified Changes for Medical Devices" (PFSB/ELD/OMDE Notification No. 1110001 dated November 10, 2008). (A “partial change” application submitted during the post- market performance review period) |
| Oct 22, 2025 | LVIS EVO StentCentral circulatory intravascular embolization prosthesis | Terumo Corporation | New device | Jul 1, 2022 | 40 mo later | 209 days | A central circulatory intravascular embolization prosthesis is used to prevent the protrusion and/or dislodgement of embolic coils into/from the parent artery during the coil embolization treatment in patients who have a wide-neck cerebral aneurysm (defined as that with a neck part of 4 mm or greater, or dome/neck ratio of less than 2) in the parent artery with a diameter of 2.0 to 4.0 mm, among the patients who have an unruptured aneurysm (with a maximum diameter of 5 mm or greater) which is difficult to treat surgically (including surgical clipping) or by coil embolization using an embolization coil alone. This product was developed based on the company's approved product "LVIS Stent (Approval No. 22700BZX00135000)" and made modifications by introducing changes to raw materials of the stent for overall visibility and reduction in diameter of the catheter used for delivery, etc. |
| Oct 20, 2025 | DUOLITH SD1 UltraExtracorporeal shockwave pain treatment device | Storz Medical Japan Co.,Ltd. | Change | Feb 21, 2021 | 56 mo later | 73 days | An extracorporeal shockwave pain treatment device is used for pain relief in patients with refractory plantar aponeurositis and for the treatment of refractory ulcer in patients with systemic scleroderma. The application was submitted to remove the indication for refractory ulcer in patients with systemic scleroderma from the intended use or indications. (A “partial change” application submitted during the post- market performance review period) |
| Oct 20, 2025 | Sphere-9 CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | Change | Not listed | — | 88 days | An ablation catheter for cardiac electrophysiological mapping as well as the treatments of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, drug refractory symptomatic persistent atrial fibrillation, and common atrial flutter. It is used in combination with a dedicated generator to deliver either radiofrequency or pulsed field energy to cardiac tissue for ablation. The application was submitted to add a manufacturing site. (A “partial change” application submitted during the post- market performance review period) |
| Oct 8, 2025 | Affera Ablation SystemPercutaneous cardiac coagulation/ablation electrosurgical unit | Medtronic Japan Co., Ltd. | Change | Not listed | — | 55 days | A generator of a radiofrequency and pulsed energy is intended for percutaneous myocardial catheter ablation. The application was submitted to add a manufacturing site. (A “partial change” application submitted during the post- market performance review period) |
| Oct 2, 2025 | nodocaEndoscopic telescope | Aillis, Inc. | Change | Not listed | — | 279 days | A system used as an aid in the diagnosis of influenza virus infection by photographing pharynx and analyzing findings of pharynx such as lymph tissue on the images (including the tonsils and lymph follicles) and clinical data to detect findings, symptoms, etc. characteristic to influenza virus infection. It is not intended to make a definitive diagnosis based only on the analysis results of this product. The application was submitted to add a function to perform a similar analysis on COVID-19 infection and provide the results when testing for influenza virus infection (A "partial change" application). |
| Oct 1, 2025 | Evolut PRO+ SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | Change | Aug 27, 2025 | 1 mo later | 299 days | A prosthetic cardiac valve system used for transcatheter valve implantation. The system mainly consists of a porcine pericardium-derived bioprosthetic valve and a delivery catheter system that is used to deploy the bioprosthetic valve at the position of the aortic valve. The application was submitted to add an indication for the treatment of patients with symptomatic valvular disease due to dysfunction of transcatheter aortic bioprosthesis and to add carotid access. (A “partial change” application submitted during the post- market performance review period) |
| Sep 25, 2025 | Digital Biomarker DNP-HFSoftware for general- purpose phonocardiograph | AMI Inc. | New device | Not listed | — | 625 days | The application was submitted for the marketing approval of a software for general-purpose phonocardiograph that analyzes the heart sounds information and the electrocardiograph provided by the combined general- purpose phonocardiograph and estimates whether the plasma BNP value is 100 pg/mL or higher, or less than 100pg/mL. The product is intended to be used to assist in making the decision to perform blood BNP test or ultrasoundcardiography. |
| Sep 24, 2025 | i-Technology Implant SystemTotal hip prosthesis | Zimmer Biomet G.K. | New device | Not listed | — | 180 days | The application was submitted for the marketing approval of total hip prosthesis to be used to replace functions of hip joint in hip replacement arthroplasty (including revision surgery) or hemiarthroplasty. This product consists of a titanium alloy femoral stem, acetabular shell, and screws. The entire surface of the implant is intended to suppress bacterial adhesion and biofilm formation, which can lead to infection, by incorporating povidone-iodine throughout the implant surface. |
| Sep 16, 2025 | VARIPULSE Pulsed Field Ablation CatheterCatheter for cardiac ablation | Johnson & Johnson K.K. | Change | Not listed | — | 95 days | A multielectrode catheter is used for conducting pulsed field ablation and cardiac electrophysiological mapping for the treatment of patients with drug-refractory symptomatic paroxysmal atrial fibrillation. The application was submitted to add a manufacturing site. (A “partial change” application submitted during the post- market performance review period) |
| Sep 16, 2025 | GORE Cardioform Septal OccluderArtificial pericardial prosthesis | W. L. Gore & Associates G.K. | Change | Apr 30, 2015 | 125 mo later | 211 days | This product is a percutaneous, transcatheter patent foramen ovale (PFO) closure device. This treatment is intended to close the PFO to reduce the risk of recurrence of ischemic stroke in patients who have had a cryptogenic stroke with possible involvement of a PFO due to a presumed paradoxical embolism. The application was submitted to add the indication for patients with iatrogenic atrial septal defect. (A “partial change” application submitted during the post- market performance review period) |
| Sep 12, 2025 | Optune LuaAlternating electric field tumor treating system | Novocure GmbH | New device | Oct 15, 2024 | 11 mo later | 625 days | The application was submitted for the marketing approval of alternating electric field tumor treating system used concurrent with a PD-1/PD-L1 inhibitor for the treatment of adult patients diagnosed with unresectable advanced or recurrent non-small cell lung cancer who have progressed on or after platinum containing chemotherapy. This product consists of the electric field generator that generates tumor treating fields and transducer arrays to be attached to the patient's chest. |
| Sep 10, 2025 | Reprocessed Intracardiac Ultrasound Catheter AS (Stryker Japan)Remanufactured central circulatory intravascular ultrasound catheter | Stryker Japan K.K. | New device | Mar 29, 2007 | 221 mo later | 194 days | A catheter for imaging of anatomical structure and physiological functions of the heart and large blood vessels from within the cardiac chamber and the lumen with a built-in transducer whose tip transmits/receives ultrasound. The product is a reprocessed single-use medical device originating from "AcuNav" (Approval No.: 22300BZX00110000) and "Soundstar SH" (Approval No.: 22400BZX00068000). |
| Sep 9, 2025 | WATCHMAN FLX Left Atrial Appendage Closure DeviceIntracardiac prosthesis | Boston Scientific Japan K.K. | Change | May 11, 2023 | 28 mo later | 263 days | The device is an intracardiac prosthesis intended to reduce a risk of thromboembolism attributed to the left atrial appendage in patients with non-valvular atrial fibrillation who are at high risk of thromboembolism. The application was submitted mainly to add intracardiac echocardiography (ICE) as an imaging modality available during surgery (A "partial change" application). |
| Sep 8, 2025 | GORE Excluder Conformable AAA Stent Graft SystemAortic stent graft | W. L. Gore & Associates G.K | Change | Apr 2024 | 17 mo later | 269 days | An aortic stent graft used for the intravascular treatment of infrarenal abdominal aortic aneurysm (including aneurysms extending from the abdominal aorta to the iliac artery) that satisfies the specific anatomical requirements. The application was submitted to change the anatomical requirement for the implantation of the graft (expansion of the indication by increasing the proximal neck angle from within 60° to within 90°) (A "partial change" application). |
| Sep 5, 2025 | Laser Device for Long-term Hair Reduction/Skin Disease GentleMax ProNd:YAG laser | Syneron Candela K.K. | Change | Dec 26, 2013K133283 | 140 mo later | 525 days | A combination device of Nd:YAG laser and Alexandrite laser intended to achieve stable long-term hair reduction by the selective photothermolysis. Alexandrite laser can be used not only for hair reduction, but also to treat superficial benign pigmented skin lesions. The application was submitted to add the treatment of capillary telangiectasia to the intended use of the Nd:YAG laser (A "partial change" application). |
| Sep 3, 2025 | FARAWAVE CatheterCatheter for cardiac ablation | Boston Scientific Japan K.K. | Change | Jul 3, 2025 | 2 mo later | 275 days | A catheter intended to be used for pulsed field ablation procedure of cardiac tissues and cardiac electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The application was submitted to add the treatment of drug-resistant, symptomatic, persistent atrial fibrillation to the intended use. (A “partial change” application submitted during the post- market performance review period) |
| Sep 3, 2025 | Biosaver ECMO Circuit Set HCHeparin-coated percutaneous cardiopulmonary support system | Nipro Corporation | New device | Not listed | — | 294 days | A heparin-coated percutaneous cardiopulmonary support system to assist the cardiopulmonary system in the treatment of severe heart failure or respiratory failure which has not responded sufficiently to drug therapies or artificial ventilation. This product consists of a blood circuit including a blood pump and oxygenator, gas circuit, cannulas and accessories and is used with a dedicated driving unit "Biosaver Console". This product was developed as a compact, lightweight ECMO system that could be used for a mid to long-term period, with the designed maximum duration of use being 14 days. |
| Sep 3, 2025 | Biosaver ConsoleDriving unit for extracorporeal circulation assist centrifugal pump | Nipro Corporation | New device | Not listed | — | 294 days | A driving unit for the centrifugal blood pump incorporated in the extracorporeal circulation circuit. This product has functions to monitor the flow rate, air bubbles, pressure, temperature, and oxygen saturation of circulating blood and is used in combination with the concomitant device "Biosaver ECMO Circuit Set HC." This product was developed as a driving unit of the compact, lightweight ECMO system that could be used for a mid to long-term period. |
| Sep 2, 2025 | CoSealAbsorbable adhesion-prevention dressing | Baxter Japan K.K. | New device | Feb 4, 2003 | 271 mo later | 883 days | An absorbable adhesion-prevention dressing is applied to the surfaces of the heart, pericardial tissues, and large blood vessels to reduce the frequency, range, and degree of postoperative adhesions in patients undergoing extracorporeal ventricular assist device surgery. |
| Sep 2, 2025 | SUSMED App for Insomnia MedcleSoftware for insomnia | Susmed, Inc. | Change | Not listed | — | 365 days | A software for insomnia to be installed on mobile terminals and used by patients with insomnia disorder. The application was submitted to clearly distinguish the product from drug therapy or face-to-face CBT-I and introduce this product as a treatment option (A "partial change" application). |
| Sep 1, 2025 | Symplicity Spyral Renal Denervation SystemRenal denervation catheter | Medtronic Japan Co., Ltd. | New device | Not listed | — | 493 days | The application was submitted for the marketing approval of a catheter for renal denervation used to lower blood pressure as an additional treatment in patients with resistant hypertension in whom blood pressure cannot be appropriately controlled with the treatments specified in the guidelines for the management of hypertension (lifestyle modification, non-drug therapy, and drug therapy). This product mainly consists of a generator that generates radiofrequency (RF) energy, a catheter that delivers RF energy, and a return electrode. |
| Sep 1, 2025 | GORE VIATORR TIPS Stent Graft with Controlled ExpansionEndoprosthetic portosystemic shunt | W. L. Gore & Associates G.K | New device | Aug 2016 | 109 mo later | 250 days | A stent graft and delivery catheter used in the therapy to reduce portal pressure by creating a shunt between the portal vein and hepatic vein via transjugular approach in patients with portal hypertension (transjugular intrahepatic portosystemic shunt). |
| Sep 1, 2025 | Elements AI SoftwareSoftware for radiation planning | Brainlab K.K. | New device | Not listed | — | 264 days | The application was submitted for the marketing approval of a software for radiation planning designed to analyze head MR images to prepare the contour of the target tumor, thereby supporting contouring in radiotherapy planning and navigation surgery planning. |
| Aug 28, 2025 | Aveir LPImplantable leadless cardiac pacemaker | Abbott Medical Japan LLC | Change | Not listed | — | 91 days | An implantable leadless cardiac pacemaker intended to be percutaneously placed in the right heart using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to change the manufacturing site. (A “partial change” application submitted during the post- market performance review period) |
| Aug 26, 2025 | HeartMate 3 Left Ventricular Assist SystemImplantable assistant artificial heart system | Thoratec Corporation | Change | Nov 19, 2024 | 9 mo later | 180 days | The device is an implantable ventricular assist device system used to assist the blood circulation for severe cardiac failure in patients who are shown continuous decompensation in spite of drug therapy or circulation assist techniques, such as an external ventricular assist system. The application was submitted mainly to add a model in which a slit is made in the bend relief (component). (A “partial change” application submitted during the post- market performance review period) |
| Aug 26, 2025 | SELUTION SLR PTA Drug-Eluting Balloon CatheterCatheter for balloon dilatation angioplasty | MedAlliance LLC | New device | Not listed | — | 300 days | A catheter for balloon dilatation angioplasty for percutaneous transluminal angioplasty in new or restenotic lesions of 200 mm or less in the superficial femoral artery or popliteal artery with a reference vessel diameter of 4.0 mm or greater and 7.0 mm or less. The balloon surface of this product is coated with a drug mainly composed of sirolimus in a microsphere form. |
| Aug 25, 2025 | Paradise SystemRenal denervation catheter | Otsuka Medical Devices Co., Ltd. | New device | Nov 7, 2023 | 22 mo later | 364 days | A catheter for renal denervation used to lower blood pressure as an additional treatment in patients with resistant hypertension in whom blood pressure cannot be appropriately controlled with the treatments specified in the guidelines for the management of hypertension (lifestyle modification, non-drug therapy, and drug therapy). This product consists of a generator, cartridge, catheter, and cooling water, and is designed to emit ultrasonic energy from the balloon to heat the sympathetic nerves around the renal artery, after inflating the balloon with cooling water in the renal artery. |
| Aug 21, 2025 | Aveir LPImplantable leadless cardiac pacemaker | Abbott Medical Japan LLC | Change | Jun 17, 2025 | 2 mo later | 85 days | An implantable leadless cardiac pacemaker intended to be percutaneously placed in the right heart using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add a model of the atrial leadless pacemaker and change MRI scanning condition. (A “partial change” application submitted during the post- market performance review period) |
| Aug 21, 2025 | Lifton DSupporting software for treatment of depression | DT-Axis Co., Ltd. | New device | Not listed | — | 268 days | A supporting software for treatment of depression based on a cognitive behavioral model, which is installed as an application in a mobile device by patients with depression under drug therapy. The present application was submitted for the marketing approval of the product by applying Section 2 of the "Handling of two-step approval based on the characteristics of Software as a Medical Device" (PSB/MDED Notification No. 1116-2 dated November 16, 2023). |
| Aug 19, 2025 | GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | Change | Jan 12, 2024 | 19 mo later | 113 days | An aortic stent graft system used for the treatment of patients with thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms who are difficult to treat with conventional surgical repair. The application was submitted to add other types of the stent grafts used in combination with this product (A "partial change" application). |
| Aug 19, 2025 | MiSight 1 DaySingle-use colored vision corrective contact lens | CooperVision Japan, Inc. | New device | Nov 15, 2019 | 69 mo later | 362 days | The application was submitted for the marketing approval of single-use colored vision corrective contact lens made of omafilcon A, which are used for vision correction and slowing progression in patients with myopia. |
| Aug 19, 2025 | Micra Transcatheter Pacing SystemImplantable leadless cardiac pacemaker | Medtronic Japan Co., Ltd. | Change | Jun 7, 2023 | 26 mo later | 186 days | An implantable electrode-integrated cardiac pacemaker intended to be percutaneously placed in the right ventricle using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add an implantation procedure via transjugular approach (A "partial change" application). |
| Aug 18, 2025 | Medtronic MiniMed 700 SeriesPortable insulin infusion pump | Medtronic Japan Co., Ltd. | Change | Not listed | — | 269 days | A glucose monitor system used for continuous subcutaneous infusion of basal insulin at a selectable rate and bolus infusion of insulin at a selectable dose. This product consists of a pump to subcutaneously administer insulin, a transmitter to send the measured value of glucose concentration in the interstitial fluid to the pump, and software to view data. A component of the approved product "Medtronic Garden Connect" (Approval No. 22900BZX00321000) is used as the sensor to measure glucose concentration in the interstitial fluid for this product. The application was submitted to add a sensor to measure glucose concentration in the interstitial fluid and improve the algorithm (A "partial change" application). |
| Aug 14, 2025 | VUE-UNO SupremeReusable limbal supported contact lens for abnormal cornea shape | OPHTECS CORPORATION | New device | Not listed | — | 267 days | The application was submitted for the marketing approval of the reusable limbal supported contact lens for abnormal cornea shape designed for vision correction in patients with corneal astigmatism whose vision cannot be corrected sufficiently by conventional eyeglasses or soft contact lenses, and who find it difficult to continuously wear hard contact lenses without any complications. |
| Aug 7, 2025 | Navitor Transcatheter Aortic Valve Implantation SystemTranscatheter bovine cardiac valve | Abbott Medical Japan LLC | Change | Jan 13, 2023 | 31 mo later | 440 days | A self-expandable percutaneous aortic bioprosthetic valve system used in symptomatic patients with severe aortic valve stenosis attributed to calcification and degeneration of the native aortic valve cusps, who are not eligible for surgery and of which this treatment is considered as their best therapeutic option. The application was submitted to add a bioprosthetic valve of 35 mm in diameter (A "partial change" application). |
| Jul 29, 2025 | ClotTriever Thrombectomy SystemCatehter for non- central circulatory embolectomy | Inari Medical, Inc. | Change | Feb 16, 2017K163549 | 101 mo later | 68 days | A catheter for non-central circulatory embolectomy used to restart blood flow in patients with deep vein thrombosis with severe acute symptoms excluding post-thrombotic syndrome. The application was submitted to add a manufacturing site. (A “partial change” application submitted during the post- market performance review period) |
| Jul 28, 2025 | Reprocessed Loop Electrode Catheter (Stryker Japan)Reprocessed cardiac catheter-tip electrode | Stryker Japan K.K. | Change | Not listed | — | 150 days | A reprocessed single-use medical device originating from “LASSO 2515” (Approval No. 21600BZY00209000) and “LASSO 2515 Navi” (Approval No. 22200BZX00740000), which is a cardiac catheter-tip electrode and is used percutaneously and transluminally placed in the heart to perform a cardiac electrophysiological study and temporary pacing. The application was submitted to add a manufacturing site (A "partial change" application). |
| Jul 28, 2025 | Reprocessed Intracardiac Ultrasound Catheter V (Stryker Japan)Remanufactured central circulatory intravascular ultrasound catheter | Stryker Japan K.K. | Change | Not listed | — | 150 days | A catheter for imaging of structure and blood flow of the heart, etc. with a built-in transducer whose tip transmits/receives ultrasound. The product is a reprocessed single-use medical device originating from "ViewFlex Xtra ICE Catheter" (Approval No.: 22600BZX00091000). The application was submitted to add a manufacturing site (A "partial change" application). |
| Jul 28, 2025 | Reprocessed Steerable Electrode Catheter (Stryker Japan)Reprocessed cardiac catheter-tip electrode | Stryker Japan K.K. | Change | Not listed | — | 150 days | A reprocessed single-use medical device originating from “Inquiry Catheter” (Approval No. 21600BZY00253000), which is a cardiac catheter-tip electrode and is used placed percutaneously and transluminally in the heart to perform a cardiac electrophysiological study and temporary pacing. The application was submitted to add a manufacturing site (A "partial change" application). |
| Jul 24, 2025 | Simplera Glucose Sensor SystemGlucose monitor system | Medtronic Japan Co., Ltd. | New device | Not listed | — | 268 days | The application was submitted for marketing approval of a continuous glucose monitoring system that continuously measures glucose levels in the interstitial fluid in people with diabetes mellitus and displays the trends and the patterns of glucose fluctuation. The product is used for assisting the detection of hyperglycemia and hypoglycemia and daily self- management by people with diabetes mellitus. This product is based on the approved product "Medtronic Guardian Connect" (Approval No. 22900BZX00321000), with modifications including the integrated sensors and transmitters, change in the sterilization method, and change in the algorithm. |
| Jul 17, 2025 | Cartilage Repair Device Mochi-GelAbsorbable cartilage regeneration material | Mochida Pharmaceutical Co., Ltd. | New device | Not listed | — | 778 days | An absorbable cartilage regeneration material used to assist in repairing the articular cartilage damage of the knee or elbow and alleviate clinical symptoms through the repaired cartilage. |
| Jul 17, 2025 | TriClip SystemPercutaneous repair system for tricuspid valve coaptation failure | Abbott Medical Japan LLC | New device | Apr 1, 2024 | 16 mo later | 352 days | A percutaneous repair system for tricuspid valve coaptation failure that consists of a delivery system with a clip to coapt the tricuspid valve with regurgitation and a steerable guide catheter to deliver the delivery system into the right atrium. The clip is percutaneously inserted to coapt any of the anterior leaflet, septal leaflet, or posterior leaflet of the tricuspid valve, thereby reducing regurgitation from the tricuspid valve. |
| Jul 15, 2025 | Esprit BTK Everolimus-Eluting Resorbable Scaffold SystemBioabsorbable drug- eluting stent for lower extremity artery | Abbott Medical Japan LLC | New device | Apr 26, 2024 | 15 mo later | 473 days | A bioabsorbable drug-eluting stent for lower limb artery used to increase the intravascular lumen diameter of the below-the-knee arterial lesions in patients with chronic limb-threatening ischaemia (CLTI) (excluding patients on chronic dialysis). The product consists of a bioresorbable scaffold and a delivery system (rapid-exchange balloon catheter). The scaffold is coated with a cytostatic drug (everolimus) and a bioresorbable polymer. |
| Jul 3, 2025 | Peripheral Rotablator ProAtherectomy ablative angioplasty catheter | Boston Scientific Japan K.K. | New device | Sep 6, 2022K220962 | 34 mo later | 944 days | The application was submitted for the marketing approval of an atherectomy ablative angioplasty catheter to be inserted percutaneously to ablate atherosclerotic plaques and/or solid calcified below-the-knee stenotic lesions in which a balloon catheter for percutaneous transluminal angioplasty cannot pass through or cannot be expanded, thereby assisting in endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This product mainly consists of an advancer/catheter to ablate the lesions and a console to control catheter movement. |
| Jun 26, 2025 | Sphere-9 CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | New device | Oct 24, 2024 | 8 mo later | 300 days | An ablation catheter for cardiac electrophysiological mapping as well as the treatments of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, drug refractory symptomatic persistent atrial fibrillation, and common atrial flutter. It is used in combination with a dedicated generator to deliver either radiofrequency or pulsed field energy to cardiac tissue for ablation. (The original product is in the post-market performance review period.) |
| Jun 26, 2025 | Affera Ablation SystemPercutaneous cardiac coagulation/ ablation electrosurgical unit | Medtronic Japan Co., Ltd. | New device | Oct 24, 2024 | 8 mo later | 300 days | A generator of a radiofrequency and pulsed energy is intended for percutaneous myocardial catheter ablation. (The original product is in the post-market performance review period.) |
| Jun 23, 2025 | Jetstream Atherectomy SystemAtherectomy ablative angioplasty catheter | Boston Scientific Japan K.K. | Change | Not listed | — | 74 days | An atherectomy ablation angioplasty catheter composed of a catheter set that is percutaneously inserted into the peripheral blood vessel to cut, crush, and suck the lesion by rotating the tip of the catheter and a console used with the catheter set. The application was submitted to change the shape of the catheter component parts and the specification values of torque strength (A “partial change” application). |
| Jun 23, 2025 | Remohab CR USoftware for cardiac exercise stress monitoring system with analytic capability | Remohab Inc. | New device | Not listed | — | 294 days | The application was submitted for marketing approval of software for cardiac exercise stress monitoring system with analytic capability intended to support the implementation of remote cardiac rehabilitation in patients with cardiovascular disease for one or multiple patients simultaneously in an online environment under the supervision of healthcare professionals. This is achieved by controlling non-active extension/traction rotary motion equipment, and providing data on the patient’s heart rate and arrhythmia. |
| Jun 19, 2025 | Visual-ICE Cryoablation SystemGeneral-purpose cryosurgical unit | Boston Scientific Japan K. K. | Change | Mar 12, 2012K113860 | 159 mo later | 267 days | A cryosurgical unit composed of the device main body that generates low temperature, etc., a needle that is inserted to freeze and necrotize the target tissue, and a multipoint temperature sensor that detects the temperature of the tissue, etc. The application was submitted to enable this system to be newly used for freezing and necrosis treatment of renal angiomyolipoma associated with tuberous sclerosis complex that is ineligible for or refractory to the standard therapy (A “partial change” application). |
| Jun 12, 2025 | UltiPaceImplantable defibrillator/ pacemaker electrode/lead | Abbott Medical Japan LLC | Change | Nov 28, 2023 | 18 mo later | 119 days | An implantable defibrillator/pacemaker electrode/lead is used in combination with an implantable cardiac pacemaker, etc. to continuously stimulate the heart muscle for a long time and to correct the heart rhythm. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add left bundle branch area pacing to its intended use (A "partial change" application). |
| Jun 12, 2025 | AutocathFFRAnalyzing software for hemodynamics or cardiac function | Medhub Ltd. | New device | Not listed | — | 470 days | This application was submitted for marketing approval of analyzing software for hemodynamics or cardiac function intended to provide fractional flow reserve (FFR) values to support the diagnosis of patients suspected of having coronary artery disease. The software calculates FFR values by automatically selecting images corresponding to the cardiac diastolic phase and containing the highest amount of contrast medium in the coronary arteries from multiple standard coronary angiographic images (DICOM data) acquired at arbitrary projection angles using an angiography system and by automatically detecting vascular stenotic lesions. |
| Jun 6, 2025 | UroLift SystemImplantable prostatic tissue retractor system | NeoTract, Inc. | Change | Not listed | — | 80 days | An implantable prostate tissue retractor system indicated for the treatment of dysuria associated with prostatic hyperplasia. The system is composed of an implant to be placed in the prostate and a delivery device which delivers the implant transurethrally to the prostate. The application was submitted to add a delivery device with a wing at the tip to improve the tissue retention force and prevent the obstruction of the visual field (A “partial change” application). |
| Jun 5, 2025 | PTeye SystemAutofluorescence detector | Medtronic Japan Co., Ltd. | New device | Not listed | — | 268 days | An autofluorescence detector that assists a surgeon in identifying the parathyroid gland that was visually specified the position by detecting autofluorescence emitted from the tissue when near infrared light is irradiated. |
| Jun 5, 2025 | Ventana DP200 Dx SystemDiagnostic assistant device for pathological whole slide image | Roche Diagnostics K.K. | New device | Not listed | — | 266 days | The application was submitted for marketing approval of a diagnostic assistant device for pathological whole slide image used for the purpose of assisting pathologists in evaluating and diagnosing high-power digital images of the entire pathological slide specimen prepared from formalin-fixed, paraffin-embedded tissue. |
| May 22, 2025 | AviClear Laser SystemDiode laser | Cutera K.K. | New device | Mar 24, 2022 | 38 mo later | 828 days | A diode laser used for the treatment of moderate to very severe acne vulgaris. The product treats acne vulgaris by reducing sebum production by means of giving damage to the sebaceous glands with heat. The results of foreign clinical studies were submitted. |
| May 12, 2025 | Evolut PRO+ SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | Change | Not listed | — | 87 days | A transcatheter porcine pericardial valve used for transcatheter aortic valve implantation. The application was submitted to add a raw material used as an additive of the inner liner of the delivery catheter system, falling under a “specified partial change” based on “Acceleration of Procedure for Specified Change for Medical Devices” (PFSB/ELD/OMDE Notification No.1110001 dated on November 10, 2008). (A “partial change” application submitted during the post- market performance review period) |
| Apr 24, 2025 | FARAWAVE CatheterCatheter for cardiac ablation | Boston Scientific Japan K. K. | Change | Oct 18, 2024 | 6 mo later | 176 days | A catheter intended to be used for pulsed field ablation procedure of cardiac tissues and cardiac electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The application was submitted to mainly add a type with a magnetic sensor. (A “partial change” application submitted during the post- market performance review period) |
| Apr 24, 2025 | FARASTAR ConsolePercutaneous cardiac coagulation/ ablation electrosurgical unit | Boston Scientific Japan K.K. | Change | Oct 18, 2024 | 6 mo later | 176 days | A pulse generator for pulsed field ablation procedures used for the treatment of arrhythmia. The application was submitted to mainly add a console type and a concomitant device, "Rhythmia HDx Mapping System" (Approval No.: 22900BZX00111000). (A “partial change” application submitted during the post- market performance review period) |
| Apr 24, 2025 | BarrigelAbsorbable tissue spacer for radiotherapy | Palette Life Sciences | New device | Not listed | — | 854 days | The application was submitted for marketing approval of an absorbable tissue spacer for radiotherapy used to reduce dose of radiation exposure to the rectum by providing space between the prostate and anterior rectal wall during radiotherapy for prostate cancer. |
| Apr 21, 2025 | Silk-Elastin Wound Healing MatrixAbsorbable dressing | Sanyo Chemical Industries, Ltd. | New device | Not listed | — | 361 days | An absorbable dressing consisting of recombinant proteins is used to heal full thickness and partial thickness wounds. The product shows a high adhesion to complicated wounds by turning silk-elastin, a recombinant protein, into a gel with the body temperature after absorbing the exudate. The product is intended to be designed to protect wounds and maintain a moist environment. Results of a Japanese clinical study were submitted. |
| Apr 15, 2025 | Mynx ControlAbsorbable topical hemostatic material | Cordis Japan G.K. | New device | Sep 2018 | 79 mo later | 355 days | An absorbable topical hemostatic material used for hemostasis at the femoral artery puncture site following percutaneous catheterization. This product is composed of a hydrogel sealant made of polyethylene glycol, bioabsorbable material, and a delivery system. The product is designed to stop bleeding by developing the hydrogel sealant to the tissue side of the vascular wall at the puncture site and closing the vascular incision site. |
| Apr 14, 2025 | Sofwave SystemUltrasonic irradiator for skin tightening | JMEC Co., Ltd. | New device | Nov 15, 2021K211483 | 41 mo later | 880 days | A device is used to improve wrinkles on the face and neck through thermocoagulation action into the dermis by irradiating ultrasound to the skin. The product is intended to improve the wrinkles of the skin by irradiating the skin with ultrasonic waves to coagulate the region mainly of the dermis at a depth of 1.5 mm from the skin surface by the thermal action. The results of foreign clinical studies were submitted. |
| Apr 11, 2025 | ERBE CRYO2General-purpose cryosurgical unit | Amco Inc. | Change | May 4, 2015K151041 | 119 mo later | 235 days | A general-purpose cryosurgical unit is used for collection of biopsy tissues, removal of foreign matters, or relief of airway obstruction in patients whose central airway is obstructed by tumors by making a probe cooled with carbon dioxide contact the target site (bronchial or bronchial peripheral tissue) or targets (foreign matters such as sputum and blood clots in the bronchus). The application was submitted to add collection of parietal pleural tissue for biopsy to the intended use (A “partial change” application). |
| Apr 7, 2025 | ReFit DentalCollagen-containing dental bone regeneration material | HOYA Technosurgical Corporation | Change | Not listed | — | 250 days | An elastic dental bone substitute consisting of low- crystalline calcium phosphate and collagen is intended for use as a support or alternative to bone regeneration and autologous bone graft (allograft) in bone defects (including extraction socket) in the dental field. The application was submitted to add bone regeneration based on implant placement to the intended use (A “partial change” application). |
| Apr 4, 2025 | Evolut FX+ SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Mar 22, 2024 | 12 mo later | 294 days | A bioprosthetic valve (derived from porcine pericardium) of the prosthetic cardiac valve system used for transcatheter valve implantation. This product was developed for easier coronary intervention after transcatheter aortic valve replacement by changing the frame design of the previous-generation product “Evolut PRO+ System” (Approval No.: 30200BZX00272000) such as making 3 windows on the frame of a bioprosthetic valve. (The original product is in the post-market performance review period.) |
| Apr 4, 2025 | KanshasCatheter for balloon dilatation angioplasty | Terumo Corporation | New device | Not listed | — | 554 days | A catheter for balloon dilatation angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral and/or popliteal arteries. The balloon surface of this product is coated with paclitaxel as a drug. |
| Apr 4, 2025 | IPCLPosterior chamber lens with crystalline lens | Atworking Co., Ltd. | New device | Not listed | — | 259 days | The application was submitted for marketing approval of posterior chamber lens with crystalline lens to be inserted into an eye intended to correct visual acuity in patients with refractive errors (myopia, myopic astigmatism). |
| Mar 25, 2025 | ComfyArt One DaySingle-use colored vision corrective contact lens | APEXLENS Co., LTD. | New device | Not listed | — | 652 days | The application was submitted for marketing approval of daily wear, single-use, colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 43% and -11 2 oxygen permeability (Dk) of 60 ×10 (cm /sec)· (mLO /(mL × mmHg)). 2 |
| Mar 25, 2025 | Garmin ECG AppSoftware for home use electrocardiograph | Garmin Japan Ltd. | New device | Jan 12, 2023 | 26 mo later | 468 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating, recording, storing, transferring, and displaying a single-channel ECG similar to Lead-I ECG, as well as functions of analyzing the generated ECG, classifying the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Mar 17, 2025 | Kaneka Broncho Dilation Catheter BR- N1Endoscopic dilation catheter | Kaneka Corporation | New device | Not listed | — | 263 days | An endoscopic dilation catheter intended to secure the bronchial lumen necessary for delivering a bronchoscope to the peripheral lung fields where bronchoscopy cannot show chest abnormal shadows. It is designed to be inserted endoscopically to dilate an intrapulmonary bronchus by dilating the balloon. |
| Mar 17, 2025 | Acriva Trinova Pro ToricMultifocal posterior chamber lens | Wakamoto Pharmaceutical Co., Ltd. | New device | Not listed | — | 266 days | The application was submitted for marketing approval of a multifocal posterior chamber lens which is used to correct near, intermediate and far vision of an aphakic eye with corneal astigmatism and reduce spectacle dependence. |
| Mar 13, 2025 | LYDEX SEALANTAbsorbable tissue reinforcement material | BMG Incorporated | New device | Not listed | — | 602 days | The application was submitted for marketing approval of an absorbable tissue reinforcement material used for preventing air leakage at the surgical closure site of lung air leak. This product consists of a powder reinforcement material and a dedicated applicator used to spray the powder material. |
| Mar 7, 2025 | ELLA-BD Stent PXAbsorbable esophageal stent | Piolax Medical Devices, Inc. | New device | Not listed | — | 253 days | The application was submitted for marketing approval of an absorbable esophageal stent used for esophageal stent placement to dilate and maintain patency of refractory benign esophageal stenosis. |
| Mar 5, 2025 | Edwards SAPIEN 3Transcatheter bovine cardiac valve | Edwards Lifesciences Limited | Change | Not listed | — | 125 days | A transcatheter bovine pericardium-derived bioprosthetic valve used for percutaneous cardiac valve implantation. The application was submitted to add a raw material of the sheath tube inner layer of the component introducer sheath set, falling under a “specified partial change” based on “Acceleration of Procedure for Specified Change for Medical Devices” (PFSB/ELD/OMDE Notification No.1110001 dated on November 10, 2008). (A “partial change” application submitted during the post-market performance review period) |
| Mar 5, 2025 | Luminor 18RX Paclitaxel Eluting PTA Balloon Dilatation CatheterCatheter for balloon dilatation angioplasty | Medico's Hirata Inc. | New device | Not listed | — | 285 days | A catheter for balloon dilatation angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral or proximal popliteal arteries. The balloon surface of this product is coated with paclitaxel as a drug. |
| Feb 21, 2025 | PulseSelect PFA Loop CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | Change | Not listed | — | 106 days | A catheter used for cardiac electrophysiology mapping and the treatment of patients with drug refractory recurrent symptomatic paroxysmal atrial fibrillation and drug refractory symptomatic persistent atrial fibrillation. The application was submitted to add a manufacturing site. (A “partial change” application submitted during the post-market performance review period) |
| Feb 13, 2025 | ENDEAVORRIDESupporting software for treatment of attention- deficit/hyperactivity disorder | Shionogi & Co., Ltd. | New device | Not listed | — | 353 days | The application was submitted for marketing approval of a supporting software for treatment of attention- deficit/hyperactivity disorder used to support the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD). |
| Feb 13, 2025 | CureApp AUD A Digital Therapeutic to Reduce Alcohol ConsumptionSupporting software for treatment of alcohol dependence | CureApp Inc. | New device | Not listed | — | 329 days | The application was submitted for marketing approval of a supporting software for treatment of alcohol dependence used to support the alcohol consumption reducing therapy for patients with alcohol dependence. |
| Feb 12, 2025 | NexpowderNon-absorbable topical hemostatic material | Century Medical Inc. | New device | Sep 6, 2022K202929 | 29 mo later | 124 days | A non-absorbable hemostatic material is used to stop non-variceal gastrointestinal bleeding. The hemostatic material is sprayed to the bleeding site by the air pressure and vibration movement generated from the spray. It is then reacted with surrounding water to form a gel, which serves as a mechanical barrier. |
| Jan 29, 2025 | Aveir LPImplantable leadless cardiac pacemaker | Abbott Medical Japan LLC | Change | Oct 11, 2024 | 4 mo later | 121 days | An implantable leadless cardiac pacemaker intended to be percutaneously placed in the right heart using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add a transmitter for remote monitoring and a raw material for a three-way stopcock. (A “partial change” application submitted during the post-market performance review period) |
| Jan 17, 2025 | Fitbit ECG App.Software for home use electrocardiograph | Fitbit LLC | New device | Sep 11, 2020 | 52 mo later | 570 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating and recording an ECG wave form similar to Lead-I ECG, as well as functions of classifying the classifiable wave form into the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Dec 24, 2024 | Naida CI M90 Sound ProcessorAuditory electrical stimulator | Nihon Bionics Co., Ltd. | New device | Dec 2, 2020P960058 | 49 mo later | 264 days | The application was submitted for marketing approval of an auditory electrical stimulator used in patients with bilateral severe hearing loss who have not responded sufficiently to wearing hearing aids. |
| Dec 24, 2024 | Paroxysmal Atrial Fibrillation Feature Detection Software SmartPAFin SeriesSoftware for general- purpose electrocardiograph | Cardio Intelligence Inc. | New device | Not listed | — | 420 days | The application was submitted for marketing approval of a software for general-purpose electrocardiograph (ECG) that analyzes electrocardiographic data obtained from a general-purpose ECG, etc. and detects features of paroxysmal atrial fibrillation. The product is used to detect features of paroxysmal atrial fibrillation and examine whether additional ECGs are required. |
| Dec 17, 2024 | FreeStyle Libre 3Glucose monitor system | Abbott Japan LLC | Change | Feb 2023 | 22 mo later | 270 days | A glucose monitor system that continuously measures glucose levels in the interstitial fluid. The monitored fluctuation patterns of the glucose level are displayed on the screen. The application was submitted mainly to add a sensor that the designed duration has been extended from 14 to 15 days to the components (A “partial change” application). |
| Dec 17, 2024 | FreeStyle Libre 2Glucose monitor system | Abbott Japan LLC | Change | Mar 3, 2023 | 22 mo later | 270 days | A glucose monitor system that continuously measures glucose levels in the interstitial fluid. The monitored fluctuation patterns of the glucose level are displayed on the screen. The application was submitted mainly to add a sensor that the designed duration has been extended from 14 to 15 days to the components (A “partial change” application). |
| Dec 17, 2024 | HemoSphere Advanced Monitoring PlatformMultiparameter monitor with critical parameters | Edwards Lifesciences Limited | Change | Jun 9, 2023K223865 | 18 mo later | 292 days | A multiparameter monitor with critical parameters intended to measure thermodilution cardiac output, arterial pressure-based cardiac output, blood pressure, venous oxygen saturation, and tissue oxygen saturation, and to collect and monitor various physiological information. Since this product includes a cerebral oximeter function, it was judged to be non- conforming to the certification standards. Following the judgement, the application was submitted for marketing approval of the product. This application was submitted to add a finger cuff for the measurement of digital arterial pressure to the components and to incorporate a non-invasive function to calculate hemodynamic parameters and hypotension prediction indices (A “partial change” application). |
| Dec 17, 2024 | Hot AXIOS SystemFistula formation prosthesis for pancreas | Boston Scientific Japan K. K. | Change | Not listed | — | 231 days | A fistula formation prosthesis for pancreas intended to form a fistula by pulling the gastrointestinal walls together or pulling the gastrointestinal and cyst walls through the gastrointestinal tract (stomach or duodenum) with endoscopic ultrasound. The application was submitted to add an indication for use for transgastric or transduodenal endoscopic gallbladder drainage in patients with acute cholecystitis who are at high risk for surgery (A "partial change" application). |
| Dec 17, 2024 | Hydron 1 Day PurePlusSingle-use colored vision corrective contact lens | Yung Sheng Optical Japan Co., Ltd. | New device | Dec 20, 2023 | 12 mo later | 265 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 44% and 2 oxygen permeability (Dk) of 120 × 10-11 (cm /sec)· (mLO )/[mL × mmHg]). 2 |
| Dec 17, 2024 | HUAWEI ECG ApplicationSoftware for home use electrocardiograph | Huawei Device Co., Ltd. | New device | Not listed | — | 484 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating, recording, storing, transferring, and displaying a single-channel ECG similar to Lead-I ECG, as well as functions of analyzing the generated ECG, classifying the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Dec 5, 2024 | Visual-ICE Cryoablation SystemGeneral-purpose cryosurgical unit | Boston Scientific Japan K. K. | Change | Mar 12, 2012K113860 | 153 mo later | 148 days | A general-purpose cryosurgical unit that freezes and necrotizes biological tissues. The application was submitted to add the followings to the intended use of this product; "liver tumor" as well as "pulmonary malignant tumor," "malignant bone tumor," "osteoid osteoma," "intrapelvic malignant tumor," and "soft tissue tumors that developed in the extremities, thoracic cavity, and abdominal cavity" that are ineligible for or refractory to standard therapy (A "partial change" application). |
| Nov 27, 2024 | GORE TAG Thoracic Branch EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | New device | May 2022 | 30 mo later | 302 days | A branch aortic stent graft system used for the intravascular treatment of thoracic descending aorta diseases. It has a branched stent graft structure that enables the treatment while preserving blood flow into the left subclavian artery. |
| Nov 27, 2024 | AI-Powered Software for Bacterial Infection Species Identification Assistance BiTTE-UrineSupporting software for microbial classification | NextGeM Inc. | New device | Not listed | — | 541 days | The application was submitted for marketing approval of supporting software for microbial classification. This software assists physicians in diagnosis by detecting and analyzing the characteristics of each bacterial cell based on urinary gram-stained images, and displaying the results of estimated bacterial species on the screen. |
| Nov 22, 2024 | Propel Sinus ImplantsBioabsorbable drug- eluting stent for sinus | Medtronic Japan Co., Ltd. | New device | Aug 11, 2011P100044 | 159 mo later | 357 days | A bioabsorbable drug-eluting stent for sinus is used for maintaining nasal patency after endoscopic sinus surgery for chronic rhinosinusitis. |
| Nov 22, 2024 | GORE VIABAHN VBX Balloon Expandable EndoprosthesisHeparin-coated stent-graft for central circulatory system | W. L. Gore & Associates G.K. | Change | Apr 22, 2024 | 7 mo later | 267 days | A heparin-coated stent-graft for a central circulatory system used to treat de novo or restenotic lesions found in the iliac arteries. The application was submitted to add an indication for the implantation of this device in the celiac, superior mesenteric, and renal arteries, when used in combination with the "GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis" (Approval No. 30600BZX00235000) for the treatment of thoracoabdominal and pararenal abdominal aortic aneurysms (A "partial change" application). |
| Nov 22, 2024 | GORE EXCLUDER AAA EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | Change | Not listed | — | 360 days | An aortic stent graft system used for the intravascular treatment of abdominal aortic aneurysms and aortic aneurysms extending from the abdominal aorta to the iliac artery. The application was submitted to enable its use in combination with the "GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis" (Approval No. 30600BZX00235000) for the treatment of thoracoabdominal and pararenal abdominal aortic aneurysms (A "partial change" application). |
| Nov 22, 2024 | GORE CTAG Thoracic EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | Change | Not listed | — | 360 days | An aortic stent graft system used for the intravascular treatment of thoracic aortic diseases. The application was submitted to enable its use in combination with the "GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis" (Approval No. 30600BZX00235000) for the treatment of thoracoabdominal aortic aneurysms (A "partial change" application). |
| Nov 22, 2024 | WaveLight EX500Ophthalmic corneal surgery laser system | Alcon Japan Ltd. | Change | Not listed | — | 267 days | An ophthalmic corneal surgery laser system with a wavelength of 193 nm using argon-fluorine gas as an oscillation medium for correction of refractive error or resection of corneal lesions by removing corneal tissues using laser irradiation. The application was submitted to broaden the target of myopia and myopic astigmatism correction by LASIK (laser in situ keratomileusis) to include myopia of -10.0 D or less, and to add hyperopia and hyperopic astigmatism correction by LASIK, in the intended use or indications (A "partial change" application). |
| Nov 19, 2024 | Solia SImplantable endocardial pacemaker electrode/lead | Biotronik Japan, Inc. | Change | Aug 30, 2024 | 3 mo later | 264 days | The device is an implantable endocardial pacemaker electrode/lead. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add left bundle branch area pacing to its intended use (A "partial change" application). |
| Nov 18, 2024 | Vivinex Gemetric PlusPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 262 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of an aphakic eye. |
| Nov 18, 2024 | Vivinex Gemetric Plus ToricPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 262 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of aphakic eyes with corneal astigmatism. |
| Nov 8, 2024 | MANTA Vascular Closure DeviceAbsorbable topical hemostatic material with collagen | Teleflex Medical Japan, Ltd. | New device | Feb 1, 2019P180025 | 69 mo later | 366 days | An absorbable topical hemostatic material with collagen used for hemostasis at the femoral artery puncture site following percutaneous catheterization. |
| Oct 28, 2024 | EXCOR Pediatric Ventricular Assist DeviceSingle-use extracorporeal assistant artificial cardiac pump | Cardio Incorporated | Change | Not listed | — | 245 days | This device is a single-use extracorporeal ventricular assist device. It is used for severe pediatric heart failure patients who cannot expect improvement of symptoms in conventional medication, surgery and circulation support. If the system is judged as best for the patients, it is used for the patients to improve circulation until reaching heart transplantation or recovery of cardiac function. The application was submitted to add an Active driving unit that is smaller and lighter than the existing ventricular assist device (A "partial change" application). |
| Oct 23, 2024 | PV 1DAY SiHYSingle-use colored vision corrective contact lens | Pegavision Corporation | New device | Not listed | — | 261 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 60% and -11 2 oxygen permeability (Dk) of 50 × 10 (cm /sec)· (mLO /[mL × mmHg]). 2 |
| Oct 22, 2024 | Aurora EV ICD MRI DeviceAutomatic implantable defibrillator | Medtronic Japan Co., Ltd. | New device | Oct 20, 2023 | 12 mo later | 265 days | An implantable defibrillator intended to treat ventricular tachycardia that performs sensing, cardioversion, anti-tachycardia pacing therapy, and defibrillation by being implanted in the body and used in combination with a substernal implantable lead. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. |
| Oct 22, 2024 | Epsila EV MRI LeadImplantable defibrillator/pacemak er electrode/lead | Medtronic Japan Co., Ltd. | New device | Oct 20, 2023 | 12 mo later | 265 days | A substernal implantable lead to be connected to an implantable cardioverter defibrillator used for sensing, cardioversion, anti-tachycardia pacing therapy, and defibrillation for ventricular tachycardia. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. |
| Oct 18, 2024 | ELVeS Laser 1470Diode laser | Integral Corporation | Change | Jan 8, 2014K130681 | 129 mo later | 595 days | A diode laser used for the treatment of the truncal saphenous veins and tributary varicose veins in primary varicose veins of the lower extremities (greater saphenous vein with vessel diameter of 20 mm or less or small saphenous vein). The application was submitted to add an indication for the treatment of tributary varicose veins originating from the trunk vein, as long as the procedure is performed concurrently with that for the trunk vein (A "partial change" application). |
| Oct 15, 2024 | Amulet Left Atrial Appendage OccluderIntracardiac prosthesis | Abbott Medical Japan LLC | New device | Aug 14, 2021 | 38 mo later | 267 days | The device is an intracardiac prosthesis intended to reduce a risk of thromboembolism attributed to the left atrial appendage in patients with non-valvular atrial fibrillation who are at high risk of thromboembolism. The device consists of a closure device, a delivery catheter, and an access system. |
| Sep 30, 2024 | Osia SystemImplantable bone- conduction hearing aid | Nihon Cochlear Co., Ltd. | New device | Jul 3, 2019K190589 | 63 mo later | 854 days | The application was submitted for marketing approval of an implantable bone-conduction hearing aid to improve the ability to hear environmental sounds and speech sounds in patients with hearing impairment who have normal bone conduction thresholds or mild impairment at least in one ear. |
| Sep 30, 2024 | Apple's hearing assist FeatureSoftware for home use hearing assist fitting | Apple Inc. | New device | Sep 12, 2024 | 1 mo later | 241 days | The application was submitted for marketing approval of software for home use hearing assist fitting that allows the user to configure the sound amplification- related settings for hearing aid based on the input audiogram results. |
| Sep 30, 2024 | Apple's hearing check featureSoftware for home use audiometry device | Apple Inc. | New device | Not listed | — | 122 days | The application was submitted for marketing approval of software for home use audiometry device used to notify the user of the possibility of hearing loss by performing air conduction audiometry. |
| Sep 27, 2024 | Aveir LPImplantable leadless cardiac pacemaker | Abbott Medical Japan LLC | Change | Jun 29, 2023 | 15 mo later | 351 days | An implantable electrode integrated cardiac pacemaker intended to be percutaneously placed in the right heart using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. This product has approved as a ventricular leadless pacemaker. The application was submitted to add an atrial leadless pacemaker in the product, and also to add the indications of atrial pacing or dual-chamber pacing that physiologically synchronizes the atria and ventricles (A "partial change" application). |
| Sep 26, 2024 | FARASTAR ConsolePercutaneous cardiac coagulation/ ablation electrosurgical unit | Boston Scientific Japan K.K. | New device | Jan 30, 2024 | 8 mo later | 321 days | A pulse generator for pulsed field ablation procedures used for the treatment of arrhythmia. (The original product is in the post-market performance review period.) |
| Sep 26, 2024 | FARAWAVE CatheterCatheter for cardiac ablation | Boston Scientific Japan K. K. | New device | Jan 30, 2024 | 8 mo later | 321 days | A catheter intended to be used for pulsed field ablation procedure of cardiac tissues and cardiac electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. (The original product is in the post-market performance review period.) |
| Sep 19, 2024 | HemeSight Analysis ProgramSoftware for gene variants analysis (for cancer genome profiling) | Otsuka Pharmaceutical Co., Ltd. | New device | Not listed | — | 174 days | The application was submitted for marketing approval of software for gene variants analysis that outputs genomic profiles summarizing hematological malignancy-related variant information, using, as input information, the base sequence data obtained by the sequence analysis of tumor and normal specimen- derived DNA and tumor specimen-derived RNA from patients with hematological malignancies or similar diseases. The output genomic profiles are used for diagnosis, selection of treatment methods, and investigation of prognosis predictions for hematological malignancies and similar disease, based on the "Guidelines for Genomic Testing of Hematological Malignancies" established by the Japanese Society of Hematology, etc. |
| Sep 19, 2024 | Acriva Trinova ProMultifocal posterior chamber lens | Wakamoto Pharmaceutical Co., Ltd. | New device | Not listed | — | 269 days | The application was submitted for marketing approval of a multifocal posterior chamber lens which is used to correct near, intermediate and far vision of an aphakic eye and reduce spectacle dependence. |
| Sep 9, 2024 | Radiopharmaceutical Synthesis Device MPS200AβRadioactive compound synthesizing facilities | Sumitomo Heavy Industries, Ltd. | Change | Not listed | — | 195 days | A radioactive compound synthesizing facility used for the semi-automated preparation of a radioisotope labeled compound, florbetapir (18F) injection used for positron emission tomography. The application was submitted to add patients suspected of having mild cognitive impairment due to Alzheimer's disease (MCI due to AD) to the indications of florbetapir (18 F) injection (A “partial change” application). |
| Sep 2, 2024 | Zeostent HGTransgastric biliary drainage stent | Zeon Medical Inc. | New device | Not listed | — | 242 days | A transgastric biliary drainage stent designed to create an anastomotic site between the gastrointestinal wall (stomach) and the bile duct in endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) for use as a drainage pathway. The product consists of a self-expanding stent with a hook-shaped anchor at the gastric wall-side distal end and a delivery system. |
| Aug 28, 2024 | da Vinci X Surgical SystemSurgical robot unit | Intuitive Surgical G.K. | Change | Not listed | — | 488 days | A device to assist surgeons' manipulation of endoscopic surgical instruments during endoscopic surgery in the areas of general digestive surgery, thoracic surgery, cardiac surgery (limited to intracardiac surgical operations under cardiac arrest), urology, gynecology, and head and neck surgery (limited to transoral surgery), to hold tissues or foreign matters, perform incisions, blunt/sharp dissection, proximal placement, ligation, incision/coagulation using high-frequency current, suturing and operation, and insertion/delivery of surgical accessories. The application was submitted for the additional indication of breast surgery (limited to nipple-sparing mastectomy) and additional concomitant devices (A “partial change” application). |
| Aug 28, 2024 | da Vinci Xi Surgical SystemSurgical robot unit | Intuitive Surgical G.K. | Change | Not listed | — | 485 days | A device to assist surgeons' manipulation of endoscopic surgical instruments during endoscopic surgery in the areas of general digestive surgery, thoracic surgery, cardiac surgery (limited to intracardiac surgical operations under cardiac arrest), urology, gynecology, and head and neck surgery (limited to transoral surgery), to hold tissues or foreign matters, perform incisions, blunt/sharp dissection, proximal placement, ligation, incision/coagulation using high-frequency current, suturing and operation, and insertion/delivery of surgical accessories. The application was submitted for the additional indication of breast surgery (limited to nipple-sparing mastectomy) and additional concomitant devices (A “partial change” application). |
| Aug 26, 2024 | CardiMax FCP-9800AiMulti-function electrocardiograph | Fukuda Denshi Co., Ltd. | New device | Not listed | — | 242 days | A multi‐functional electrocardiograph intended for ECG with 12 leads including limb leads and chest leads. The device was developed based on the "CardiMax FCP-9800" (Certification No.: 303ADBZX00038000). The change is addition of a function that estimates the possibility of paroxysmal atrial fibrillation occurring in the past 2 years. |
| Aug 26, 2024 | Apple's Sleep Apnea Notification FeatureSoftware for analysis of home use body motion information | Apple Inc. | New device | Sep 13, 2024 | 1 mo earlier | 270 days | The application was submitted for marketing approval of software for analysis of home use body motion information that analyzes wrist motion data from the built-in accelerometer of the Apple Watch to detect any irregular breathing suggestive of sleep apnea and notifies the user of it. |
| Aug 23, 2024 | RST Calculation ProgramSoftware for analysis of body motion information | HeartLab, Inc. | New device | Not listed | — | 333 days | Software for analysis of body motion information used to provide an index related to respiratory stability by analyzing nocturnal body motion data. The present application for marketing approval of the product was submitted based on the "Concept of two-step approval of Software as a Medical Device for disease diagnosis" described in the "Handling of two-step approval based on the characteristics of Software as a Medical Device" (PSB/MDED Notification No. 1116- 2 dated November 16, 2023). |
| Aug 8, 2024 | Penumbra System 4Catheter for central circulatory embolectomy | Medico's Hirata Inc. | New device | Not listed | — | 146 days | A catheter for central circulatory embolectomy used for revascularization for patients with acute ischemic stroke (in principle, within 8 hours of the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) therapy or who failed in revascularization with the t-PA therapy. A clinical evaluation report summarizing the contents of Japanese and foreign clinical literature, etc. was submitted to evaluate the efficacy and safety of ADAPT. |
| Aug 2, 2024 | TECNIS PureSee Extended Depth of Focus IOL SimplicityPosterior chamber lens with inserter | AMO Japan K.K. | New device | Not listed | — | 224 days | The application was submitted for marketing approval of a posterior chamber lens with inserter. |
| Aug 2, 2024 | TECNIS PureSee Toric Extended Depth of Focus IOL SimplicityPosterior chamber lens with inserter | AMO Japan K.K. | New device | Not listed | — | 224 days | The application was submitted for marketing approval of a posterior chamber lens with inserter. |
| Aug 2, 2024 | COMBO Plus Coronary StentMurine antibody- coated coronary stent | Orbusneich Medical K. K. | Change | Not listed | — | 219 days | A coronary stent system consists of a drug-eluting stent used to treat patients with ischemic heart disease and a delivery catheter to deploy a stent to the stenosed lesion. A murine-derived anti-CD34 antibody and sirolimus are coated on the stent surface of the device. The application was submitted to add stent sizes (A "partial change" application). |
| Aug 2, 2024 | Endoscopic Surgery Support Program SurVis-HysSupporting software for surgical image recognition | Jmees Inc. | New device | Not listed | — | 368 days | The application was submitted for marketing approval of supporting software for surgical image recognition. This software assists surgeons with image recognition by processing image data obtained from an endoscopy system and highlighting candidate areas of the ureter and bladder during surgery. |
| Jul 29, 2024 | pRESET Stent RetrieverCatheter for central circulatory embolectomy | phenox Limited | New device | Jan 20, 2023K222848 | 18 mo later | 391 days | A catheter for central circulatory embolectomy that is intended for use to restore blood flow by removing clots from the intracranial blood vessel in patients with acute ischemic stroke (in principle, within 8 hours from the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed to restore blood flow with the t-PA therapy. The results of foreign clinical studies were submitted. |
| Jul 24, 2024 | SENTINEL Cerebral Protection SystemCentral circulatory catheter for trapping embolus | Boston Scientific Japan K.K. | New device | Jun 1, 2017 | 86 mo later | 254 days | A distal embolic protection device designed to temporarily place filters at the aortic bifurcation (brachiocephalic artery and left common carotid artery) for capturing and removing substances causing embolization during transcatheter aortic valve replacement (TAVR). |
| Jul 11, 2024 | iStent inject Trabecular Micro-Bypass SystemHeparin-coated drain for intraocular | Glaukos Corporation | Change | Not listed | — | 265 days | A stent and the injector used for lowering intraocular pressure in patients with mild to moderate open-angle glaucoma. The application was submitted to expand the indications by adding the use of the product alone to the conventional indications for simultaneous use in cataract surgery, and to add a new type of injector (A "partial change" application). |
| Jun 24, 2024 | LymmityPneumatically- powered sequential device for stimulating lymph flow | Techno Takatsuki Co., Ltd. | New device | Not listed | — | 346 days | A pneumatically-powered sequential device for stimulating lymph flow to reduce edema in patients with lymphedema by applying pneumatic compression to the affected limb and trunk. The product consists of a main unit with a built-in actuator and sleeves that compress the affected limb and trunk. As clinical evaluation data, a clinical evaluation report summarizing the literature research data on a foreign clinical study of intermittent pneumatic compression therapy with a similar product was submitted. |
| Jun 24, 2024 | C2 CryoBalloon Ablation SystemGeneral-purpose cryosurgical unit | HOYA Corporation | Change | Not listed | — | 312 days | A general-purpose cryosurgical unit intended for endoscopic cryoablation of lesion tissue. This product has already been approved for use in patients with "endoscopically-unresectable, recurrent Barrett's esophageal lesion associated with dysplasia or noninvasive adenocarcinoma that has arisen from residual diseased tissue or in/around the scar after endoscopic resection." The application was submitted to add the indication of “endoscopically-unresectable, recurrent esophageal squamous cell carcinoma that has arisen from residual diseased tissue or in/around the scar after endoscopic resection” (A “partial change” application). |
| Jun 19, 2024 | Medilizer AGD SystemCerebrovascular guiding assist device | Bolt Medical, Inc. | New device | Not listed | — | 266 days | A cerebrovascular guiding assist device used to deliver an endovascular treatment device to a target lesion. The product is used in cases where the delivery of endovascular treatment devices including catheters is difficult by traditional methods due to vascular tortuosity, etc. The results of clinical studies conducted in Japan were submitted. |
| Jun 19, 2024 | PODEYE ToricPosterior chamber lens | Beaver-Visitec International Japan K.K. | New device | Not listed | — | 265 days | The application was submitted for marketing approval of a posterior chamber lens with cylindrical refractivity to be implanted in the posterior chamber of the eye to replace a cloudy crystalline lens and restore vision. |
| Jun 19, 2024 | CardiMax FCP-9900Ai SystemMulti-function electrocardiograph | Fukuda Denshi Co., Ltd. | New device | Not listed | — | 257 days | A multi-functional electrocardiograph intended for ECG with at least 12 leads including limb leads and chest leads. The device was developed based on “CardiMax FCP-9900 System” (Certification No.: 301ADBZX00034000). The change is addition of a function that estimates the possibility of paroxysmal atrial fibrillation occurring in the past 2 years. |
| Jun 18, 2024 | POLARx Cryoablation Balloon CatheterCatheter for cardiac ablation | Boston Scientific Japan K.K. | Change | Not listed | — | 82 days | A balloon catheter used for cryoablation of cardiac tissue. The application was submitted to add “the treatment of drug-resistant, symptomatic, persistent atrial fibrillation” to the existing intended use (the treatment of drug-refractory, recurrent, symptomatic, paroxysmal arterial fibrillation) and “compatibility with electric powered injectors” to the specifications related to performance and safety (A "partial change" application). |
| Jun 18, 2024 | SelectSecure LeadImplantable endocardial pacemaker electrode/lead | Medtronic Japan Co., Ltd. | Change | Oct 1, 2022 | 21 mo later | 230 days | The device is an implantable endocardial pacemaker electrode/lead. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add left bundle branch area pacing to its intended use (A "partial change" application). |
| Jun 12, 2024 | Kaneka Cutting Balloon Catheter CO- R1Catheter for coronary balloon dilatation angioplasty | Kaneka Corporation | New device | Not listed | — | 160 days | A balloon catheter used to dilate coronary stenosis that is difficult to dilate with a conventional balloon catheter. The balloon has integrated blades along its surface. |
| Jun 10, 2024 | Gold Anchor MarkerImplantable lesion identification marker | GA Japan Company, Inc. | Change | Not listed | — | 180 days | A serrated gold wire to be implanted in the body to create an identification maker that can be visualized on film or digital imaging during radiation therapy. It is an implantable lesion identification marker used for locating and delineating malignant tumors in the lung, prostate, liver, pancreas, and breast in the trunk of the body. The application was submitted to add the kidney and uterus to the indications and change the shapes and measurements of the needle components (A “partial change” application). |
| Jun 6, 2024 | Hydrus Glaucoma MicrostentIntraocular drain | Alcon Japan Ltd. | New device | Aug 10, 2018P170034 | 70 mo later | 252 days | The application was submitted for marketing approval of a stent and its delivery system used simultaneously during cataract surgery to lower intraocular pressure in patients with mild to moderate open-angle glaucoma. |
| Jun 3, 2024 | SEERSOphthalmic material for maintaining visibility | Menicon Co., Ltd. | New device | Not listed | — | 270 days | The application was submitted for marketing approval of an ophthalmic material for maintaining visibility during open surgery to treat glaucoma. The product is a prefilled syringe loaded with synthetic peptide in a clear gel formulation, which is applied to the area of observation or treatment to ensure a clear operative field and help with observation and treatment. |
| May 23, 2024 | TRUFILL n-BCA Liquid Embolic SystemCentral circulatory intravascular embolization prosthesis | Johnson & Johnson K.K. | New device | Sep 25, 2000P990040 | 284 mo later | 315 days | A central circulatory intravascular embolization prosthesis is used as an embolic agent for vascular embolization in cases where embolization is needed before surgical removal of cerebral arteriovenous malformation refractory to non-surgical approaches or in dural arteriovenous fistula that is difficult to treat sufficiently with transvenous embolization, etc. A clinical evaluation report summarizing the literature research data, etc. on the efficacy and safety of this product was submitted. |
| May 14, 2024 | GORE Cardioform Septal OccluderArtificial pericardial prosthesis | W. L. Gore & Associates G.K. | Change | Not listed | — | 116 days | This product is a percutaneous, transcatheter patent foramen ovale (PFO) closure device. This treatment is intended to close the PFO to reduce the risk of recurrence of ischemic stroke in patients who have had a cryptogenic stroke with possible involvement of a PFO due to a presumed paradoxical embolism. The application was submitted to correct discrepancy in the descriptions of raw materials in the approval document (A "partial change" application). |
| May 8, 2024 | Apple's Atrial Fibrillation History FeatureSoftware for home use heart rate monitor | Apple Inc. | New device | Not listed | — | 398 days | The application was submitted for marketing approval of a software for home use heart rate monitor. The device is used to analyze pulse rate data to identify episodes suggestive of atrial fibrillation, and to provide users with the estimated percentage of time that the heart showed the signs of atrial fibrillation in the past relative to the time wearing the Apple Watch. |
| May 2, 2024 | PulseSelect PFA Loop CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | New device | Dec 13, 2023 | 5 mo later | 293 days | A catheter to conduct pulsed field ablation for cardiac electrophysiological mapping and the treatments of patients with drug refractory recurrent symptomatic paroxysmal atrial fibrillation and drug refractory symptomatic persistent atrial fibrillation. (The original product is in the post-market performance review period.) |
| May 2, 2024 | PulseSelect PFA GeneratorPercutaneous cardiac coagulation/ ablation electrosurgical unit | Medtronic Japan Co., Ltd. | New device | Dec 13, 2023 | 5 mo later | 293 days | A pulse generator intended for percutaneous myocardial catheter ablation by the use of pulsed electric fields. (The original product is in the post-market performance review period.) |
| Apr 22, 2024 | RESONATE ICD SeriesAutomatic implantable defibrillator | Boston Scientific Japan K. K. | Change | May 2, 2017 | 84 mo later | 130 days | The device is an automatic implantable defibrillator. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The application was submitted to add a model with a function to provide indicators related to the changes in the patient’s biological information (HeartLogic function) as per the section 3 in the "Handling on the Scope of Situations where 'Documents related to Clinical Study Results' is Necessary on Medical Devices (Operations based on Measures through Pre-and Post-Marketing Phases), (PSEHB/MDED Notification No. 1117-1 and PSEHB/SD Notification No. 1117-1 dated on November 17, 2017)" (A “partial change” application). |
| Mar 29, 2024 | AQUABEAM Robotic SystemSurgical robot unit | PROCEPT BioRobotics Corporation | Change | Dec 21, 2017 | 75 mo later | 99 days | A device to resect and remove prostate tissues of male patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The application was submitted to add a manufacturing site. (A "partial change" application submitted during the post-market performance review period) |
| Mar 27, 2024 | IN.PACT Admiral Drug-Coated Balloon (DCB) CatheterCatheter for balloon dilatation angioplasty | Medtronic Japan Co., Ltd. | Change | May 25, 2018 | 70 mo later | 271 days | A paclitaxel-coated balloon-dilating catheter for angioplasty used for purposes including reducing restenosis of target blood vessels in the superficial femoral and popliteal arteries. The application was submitted to add a balloon length of 250 mm and change the target maximum lesion length from 200 mm to 350 mm (A "partial change" application). |
| Mar 14, 2024 | Reprocessed Loop Electrode Catheter (Stryker Japan)Reprocessed cardiac catheter-tip electrode | Stryker Japan K.K. | Change | Not listed | — | 87 days | A reprocessed single-use medical device originating from “LASSO 2515” (Approval No. 21600BZY00209000) and “LASSO 2515 Navi” (Approval No. 22200BZX00740000), which is a cardiac catheter-tip electrode and is used percutaneously and transluminally placed in the heart to perform a cardiac electrophysiological study and temporary pacing. The application was submitted to change the manufacturing process (A "partial change" application). |
| Mar 5, 2024 | Edwards SAPIEN 3Transcatheter bovine cardiac valve | Edwards Lifesciences Limited | Change | Not listed | — | 151 days | A prosthetic cardiac valve system used for transcatheter valve implantation. The system mainly consists of a bovine pericardium-derived bioprosthetic valve and a delivery system that is used to deploy the bioprosthetic valve at the valve position. The application was submitted to add ISO80369-7 to the applicable standards of plural connectors included in the components of this product and to add raw materials for the introducer and loader. (A "partial change" application submitted during the post-market performance review period) |
| Feb 15, 2024 | Phototherapy Device for Skin Disease/Long-term Hair Reduction NordlysPhototherapy device for skin disease | Syneron Candela K.K. | Change | Jul 15, 2015K150907 | 103 mo later | 290 days | A phototherapy device for skin diseases used to treat superficial skin benign pigmentary diseases, improve superficial telangiectasia symptoms in benign cutaneous vascular lesions, and achieve long-term hair reduction by thermal action of continuous spectral light from visible to infrared rays contained in intense pulse light. The application was submitted to add the long-term hair reduction to the indication of the product (A "partial change" application). |
| Feb 13, 2024 | Edwards SAPIEN 3Transcatheter bovine cardiac valve | Edwards Lifesciences Limited | Change | Jun 17, 2015 | 104 mo later | 231 days | A prosthetic cardiac valve system used for transcatheter valve implantation. The system mainly consists of a bovine pericardium-derived bioprosthetic valve and a delivery system that is used to deploy the bioprosthetic valve at the valve position. The application was submitted to add a method to deliver a prosthetic valve via the common carotid artery, which is a route to be considered for patients for whom the valve cannot be delivered safely via the femoral artery. (A "partial change" application submitted during the post-market performance review period) |
| Feb 13, 2024 | Gore Viabahn Stent GraftHeparin-coated stent-graft for central circulatory system | W. L. Gore & Associates, G.K. | Change | Sep 2014 | 113 mo later | 270 days | A stent graft system consisting of a stent graft with nitinol stent wires wound around the outside of the graft (external stent structure type) and a delivery catheter. The application was submitted for an additional indication of in-stent restenosis lesions among symptomatic peripheral arterial diseases in the superficial femoral artery (A "partial change" application). |
| Feb 6, 2024 | Paravalvular Leak Closure SetArtificial pericardial prosthesis | Japan Lifeline Co., Ltd. | Change | Not listed | — | 221 days | A device consisting of an occluder, pusher, and loader intended to be used for percutaneous closure of a defect hole for prosthetic paravalvular regurgitation. This application was submitted mainly to add a pistol pusher. (A "partial change" application submitted during the post-market performance review period) |
| Feb 6, 2024 | MAGNETOM TerraSuperconducting magnet head/extremity imaging MRI system | Siemens Healthcare K.K. | New device | Not listed | — | 364 days | The application was submitted for marketing approval of a superconducting magnet head/extremity imaging MRI system with a static magnetic field strength of 7T that performs computer processing magnetic resonance signals related to the patient's head or extremity and presents the reconstructed imaging for medical care purposes. |
| Jan 26, 2024 | RFA Lesion SystemRadio-frequency ablation system | Century Medical, Inc. | Change | Not listed | — | 217 days | A radio-frequency ablation system used for coagulating and ablating tissues. The application was submitted to add the followings to the intended use of this product; "small malignant renal mass" as well as "pulmonary malignant tumor," "malignant bone tumor," "osteoid osteoma," "intrapelvic malignant tumor," and "soft tissue tumors that developed in the extremities, thoracic cavity, and abdominal cavity" that are ineligible for or refractory to standard therapy (A “partial change” application). |
| Jan 22, 2024 | FreeStyle Libre 3Glucose monitor system | Abbott Japan LLC | New device | Not listed | — | 270 days | The application was submitted for marketing approval of a glucose monitor system that continuously measures glucose levels in the interstitial fluid. The monitored fluctuation patterns of the glucose level are displayed on the screen. |
Palette Life SciencesEvery New Device Since 2007
Sort by the gap to find the longest waits, or by review time.| Dec 24, 2025 | Digital Biomarker DNP-ASSoftware for general- purpose phonocardiograph | AMI Inc. | New device | Not listed | — | 456 days | The application was submitted for marketing approval of a software for general-purpose phonocardiograph used to analyze information on heart sounds and electrocardiograms provided by the general-purpose phonocardiograph and estimates whether or not aortic valve stenosis is moderate or more severe. The product is intended to be used to assist in making the decision to perform ultrasoundcardiography. |
| Dec 19, 2025 | remede SystemImplantable phrenic nerve electrical stimulator | Zoll Respicardia, Inc. | New device | Oct 2017P160039 | 98 mo later | 1793 days | An implantable phrenic nerve electrical stimulator designed to induce diaphragm contraction through transvenous phrenic nerve stimulation in adult patients with moderate to severe central sleep apnea who are ineligible for, or intolerant to, positive pressure ventilation and oxygen therapy. This product consists of an implantable stimulator for implanting under the clavicle, a lead for detection of respiration and stimulation, a delivery system used for implantation of the lead, and other components. |
| Dec 19, 2025 | PHIL SystemCentral circulatory intravascular embolization prosthesis | Terumo Corporation | New device | Dec 31, 2025 | Same month | 267 days | A central circulatory intravascular embolization prosthesis is used for vascular embolization before surgical resection of cerebral arteriovenous malformation that requires surgical treatment, or for vascular embolization of dural arteriovenous fistula that is difficult to treat curatively with transvenous embolization, radiation therapy and surgical treatment. |
| Dec 19, 2025 | Precision 7Reusable colored vision corrective contact lens | Alcon Japan Ltd. | New device | Dec 2, 2021 | 49 mo later | 266 days | This application was submitted for marketing approval of a reusable colored vision corrective contact lens for daily wear and continuous wear (for a maximum of 1 week). The lens is composed of silicone hydrogel with a water - content of 55% and oxygen permeability (Dk) of 119 × 10 11 2 /sec)•(mLO (cm /(mL×mmHg)). 2 |
| Dec 5, 2025 | SeQuent Please Ph Drug Eluting Balloon CatheterCatheter for balloon dilatation angioplasty | Nipro Corporation | New device | Not listed | — | 995 days | A Catheter for balloon dilatation angioplasty is used for percutaneous transluminal angioplasty in patients who have de novo, restenosis, or in-stent restenosis lesions with a length of 50 mm or greater to 200 mm or less in the superficial femoral artery and popliteal artery with a reference vessel diameter of 4.0 mm or greater to 7.0 mm or less. The balloon surface of this product is coated with paclitaxel as a drug. |
| Dec 3, 2025 | SweatWatchSweat lactate monitoring system | Grace Imaging, Inc. | New device | Not listed | — | 636 days | A sweat lactate monitoring system that provides information to set exercise loads by measuring and displaying changes over time in the patient's sweat lactate concentration during exercise. This product consists of a sensor chip, a sensor device, a data display program, and other components. The product was developed as a device to facilitate the implementation of cardiopulmonary exercise testing used in cardiac rehabilitation, etc. |
| Dec 3, 2025 | TightRail FamilyPacemaker/ defibrillator lead extraction kit | Philips Japan, Ltd. | New device | Mar 4, 2015K150360 | 129 mo later | 230 days | The application was submitted for marketing approval of a pacemaker/defibrillator lead extraction kit intended to be used to facilitate extraction of cardiac leads, incorporating a mechanism to expose and rotate a blade from the sheath tip via manipulation of the handle. |
| Nov 26, 2025 | CT LUCIA 621P Monofocal Intraocular LensHeparin-coated posterior chamber lens | Carl Zeiss Meditec Co., Ltd. | New device | Feb 7, 2023 | 34 mo later | 268 days | This application was submitted for marketing approval of a heparin-coated posterior chamber lens and a posterior chamber lens with inserter, which a monofocal posterior chamber lens is preloaded into an injector, and the lens is intended to be inserted as a substitute for a crystalline lens by implanting in the posterior chamber to correct visual acuity of aphakic eyes. |
| Nov 19, 2025 | OmniaSecure MRI LeadImplantable defibrillator/ pacemaker electrode/lead | Medtronic Japan Co., Ltd. | New device | Apr 22, 2025 | 7 mo later | 233 days | An implantable defibrillator lead that is connected to an implantable defibrillator and a defibrillator with biventricular pacing function. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. The main feature of this product is that the lead diameter is reduced compared with conventional defibrillator leads by removing the lumen for stylet insertion, etc., as with the company's approved pacemaker lead "SelectSecure Lead" (Approval No. 22400BZX00005000). |
| Nov 5, 2025 | Apple's Hypertension Notification FeatureSoftware for analysis of home use pulse wave information | Apple Inc. | New device | Sep 11, 2025 | 2 mo later | 211 days | The application was submitted for marketing approval of a software for analysis of home use pulse wave information used to analyze data obtained by photoplethysmography, detect patterns suggestive of hypertension, and notify the user. |
| Oct 31, 2025 | Restylane DefyneHyaluronic acid- containing injectable soft tissue | Galderma KK | New device | Dec 9, 2016 | 107 mo later | 612 days | The application was submitted for marketing approval of a hyaluronic acid-containing injectable soft tissue indicated for injection into the mid to deep dermis for the correction and the improvement of appearance of moderate to severe facial wrinkles (such as nasolabial folds). |
| Oct 31, 2025 | Restylane RefyneHyaluronic acid- containing injectable soft tissue | Galderma KK | New device | Dec 9, 2016 | 107 mo later | 582 days | The application was submitted for marketing approval of a hyaluronic acid-containing injectable soft tissue indicated for injection into the mid to deep dermis for the correction and the improvement of appearance of moderate to severe facial wrinkles (such as nasolabial folds). |
| Oct 22, 2025 | LVIS EVO StentCentral circulatory intravascular embolization prosthesis | Terumo Corporation | New device | Jul 1, 2022 | 40 mo later | 209 days | A central circulatory intravascular embolization prosthesis is used to prevent the protrusion and/or dislodgement of embolic coils into/from the parent artery during the coil embolization treatment in patients who have a wide-neck cerebral aneurysm (defined as that with a neck part of 4 mm or greater, or dome/neck ratio of less than 2) in the parent artery with a diameter of 2.0 to 4.0 mm, among the patients who have an unruptured aneurysm (with a maximum diameter of 5 mm or greater) which is difficult to treat surgically (including surgical clipping) or by coil embolization using an embolization coil alone. This product was developed based on the company's approved product "LVIS Stent (Approval No. 22700BZX00135000)" and made modifications by introducing changes to raw materials of the stent for overall visibility and reduction in diameter of the catheter used for delivery, etc. |
| Sep 25, 2025 | Digital Biomarker DNP-HFSoftware for general- purpose phonocardiograph | AMI Inc. | New device | Not listed | — | 625 days | The application was submitted for the marketing approval of a software for general-purpose phonocardiograph that analyzes the heart sounds information and the electrocardiograph provided by the combined general- purpose phonocardiograph and estimates whether the plasma BNP value is 100 pg/mL or higher, or less than 100pg/mL. The product is intended to be used to assist in making the decision to perform blood BNP test or ultrasoundcardiography. |
| Sep 24, 2025 | i-Technology Implant SystemTotal hip prosthesis | Zimmer Biomet G.K. | New device | Not listed | — | 180 days | The application was submitted for the marketing approval of total hip prosthesis to be used to replace functions of hip joint in hip replacement arthroplasty (including revision surgery) or hemiarthroplasty. This product consists of a titanium alloy femoral stem, acetabular shell, and screws. The entire surface of the implant is intended to suppress bacterial adhesion and biofilm formation, which can lead to infection, by incorporating povidone-iodine throughout the implant surface. |
| Sep 12, 2025 | Optune LuaAlternating electric field tumor treating system | Novocure GmbH | New device | Oct 15, 2024 | 11 mo later | 625 days | The application was submitted for the marketing approval of alternating electric field tumor treating system used concurrent with a PD-1/PD-L1 inhibitor for the treatment of adult patients diagnosed with unresectable advanced or recurrent non-small cell lung cancer who have progressed on or after platinum containing chemotherapy. This product consists of the electric field generator that generates tumor treating fields and transducer arrays to be attached to the patient's chest. |
| Sep 10, 2025 | Reprocessed Intracardiac Ultrasound Catheter AS (Stryker Japan)Remanufactured central circulatory intravascular ultrasound catheter | Stryker Japan K.K. | New device | Mar 29, 2007 | 221 mo later | 194 days | A catheter for imaging of anatomical structure and physiological functions of the heart and large blood vessels from within the cardiac chamber and the lumen with a built-in transducer whose tip transmits/receives ultrasound. The product is a reprocessed single-use medical device originating from "AcuNav" (Approval No.: 22300BZX00110000) and "Soundstar SH" (Approval No.: 22400BZX00068000). |
| Sep 3, 2025 | Biosaver ECMO Circuit Set HCHeparin-coated percutaneous cardiopulmonary support system | Nipro Corporation | New device | Not listed | — | 294 days | A heparin-coated percutaneous cardiopulmonary support system to assist the cardiopulmonary system in the treatment of severe heart failure or respiratory failure which has not responded sufficiently to drug therapies or artificial ventilation. This product consists of a blood circuit including a blood pump and oxygenator, gas circuit, cannulas and accessories and is used with a dedicated driving unit "Biosaver Console". This product was developed as a compact, lightweight ECMO system that could be used for a mid to long-term period, with the designed maximum duration of use being 14 days. |
| Sep 3, 2025 | Biosaver ConsoleDriving unit for extracorporeal circulation assist centrifugal pump | Nipro Corporation | New device | Not listed | — | 294 days | A driving unit for the centrifugal blood pump incorporated in the extracorporeal circulation circuit. This product has functions to monitor the flow rate, air bubbles, pressure, temperature, and oxygen saturation of circulating blood and is used in combination with the concomitant device "Biosaver ECMO Circuit Set HC." This product was developed as a driving unit of the compact, lightweight ECMO system that could be used for a mid to long-term period. |
| Sep 2, 2025 | CoSealAbsorbable adhesion-prevention dressing | Baxter Japan K.K. | New device | Feb 4, 2003 | 271 mo later | 883 days | An absorbable adhesion-prevention dressing is applied to the surfaces of the heart, pericardial tissues, and large blood vessels to reduce the frequency, range, and degree of postoperative adhesions in patients undergoing extracorporeal ventricular assist device surgery. |
| Sep 1, 2025 | Symplicity Spyral Renal Denervation SystemRenal denervation catheter | Medtronic Japan Co., Ltd. | New device | Not listed | — | 493 days | The application was submitted for the marketing approval of a catheter for renal denervation used to lower blood pressure as an additional treatment in patients with resistant hypertension in whom blood pressure cannot be appropriately controlled with the treatments specified in the guidelines for the management of hypertension (lifestyle modification, non-drug therapy, and drug therapy). This product mainly consists of a generator that generates radiofrequency (RF) energy, a catheter that delivers RF energy, and a return electrode. |
| Sep 1, 2025 | GORE VIATORR TIPS Stent Graft with Controlled ExpansionEndoprosthetic portosystemic shunt | W. L. Gore & Associates G.K | New device | Aug 2016 | 109 mo later | 250 days | A stent graft and delivery catheter used in the therapy to reduce portal pressure by creating a shunt between the portal vein and hepatic vein via transjugular approach in patients with portal hypertension (transjugular intrahepatic portosystemic shunt). |
| Sep 1, 2025 | Elements AI SoftwareSoftware for radiation planning | Brainlab K.K. | New device | Not listed | — | 264 days | The application was submitted for the marketing approval of a software for radiation planning designed to analyze head MR images to prepare the contour of the target tumor, thereby supporting contouring in radiotherapy planning and navigation surgery planning. |
| Aug 26, 2025 | SELUTION SLR PTA Drug-Eluting Balloon CatheterCatheter for balloon dilatation angioplasty | MedAlliance LLC | New device | Not listed | — | 300 days | A catheter for balloon dilatation angioplasty for percutaneous transluminal angioplasty in new or restenotic lesions of 200 mm or less in the superficial femoral artery or popliteal artery with a reference vessel diameter of 4.0 mm or greater and 7.0 mm or less. The balloon surface of this product is coated with a drug mainly composed of sirolimus in a microsphere form. |
| Aug 25, 2025 | Paradise SystemRenal denervation catheter | Otsuka Medical Devices Co., Ltd. | New device | Nov 7, 2023 | 22 mo later | 364 days | A catheter for renal denervation used to lower blood pressure as an additional treatment in patients with resistant hypertension in whom blood pressure cannot be appropriately controlled with the treatments specified in the guidelines for the management of hypertension (lifestyle modification, non-drug therapy, and drug therapy). This product consists of a generator, cartridge, catheter, and cooling water, and is designed to emit ultrasonic energy from the balloon to heat the sympathetic nerves around the renal artery, after inflating the balloon with cooling water in the renal artery. |
| Aug 21, 2025 | Lifton DSupporting software for treatment of depression | DT-Axis Co., Ltd. | New device | Not listed | — | 268 days | A supporting software for treatment of depression based on a cognitive behavioral model, which is installed as an application in a mobile device by patients with depression under drug therapy. The present application was submitted for the marketing approval of the product by applying Section 2 of the "Handling of two-step approval based on the characteristics of Software as a Medical Device" (PSB/MDED Notification No. 1116-2 dated November 16, 2023). |
| Aug 19, 2025 | MiSight 1 DaySingle-use colored vision corrective contact lens | CooperVision Japan, Inc. | New device | Nov 15, 2019 | 69 mo later | 362 days | The application was submitted for the marketing approval of single-use colored vision corrective contact lens made of omafilcon A, which are used for vision correction and slowing progression in patients with myopia. |
| Aug 14, 2025 | VUE-UNO SupremeReusable limbal supported contact lens for abnormal cornea shape | OPHTECS CORPORATION | New device | Not listed | — | 267 days | The application was submitted for the marketing approval of the reusable limbal supported contact lens for abnormal cornea shape designed for vision correction in patients with corneal astigmatism whose vision cannot be corrected sufficiently by conventional eyeglasses or soft contact lenses, and who find it difficult to continuously wear hard contact lenses without any complications. |
| Jul 24, 2025 | Simplera Glucose Sensor SystemGlucose monitor system | Medtronic Japan Co., Ltd. | New device | Not listed | — | 268 days | The application was submitted for marketing approval of a continuous glucose monitoring system that continuously measures glucose levels in the interstitial fluid in people with diabetes mellitus and displays the trends and the patterns of glucose fluctuation. The product is used for assisting the detection of hyperglycemia and hypoglycemia and daily self- management by people with diabetes mellitus. This product is based on the approved product "Medtronic Guardian Connect" (Approval No. 22900BZX00321000), with modifications including the integrated sensors and transmitters, change in the sterilization method, and change in the algorithm. |
| Jul 17, 2025 | Cartilage Repair Device Mochi-GelAbsorbable cartilage regeneration material | Mochida Pharmaceutical Co., Ltd. | New device | Not listed | — | 778 days | An absorbable cartilage regeneration material used to assist in repairing the articular cartilage damage of the knee or elbow and alleviate clinical symptoms through the repaired cartilage. |
| Jul 17, 2025 | TriClip SystemPercutaneous repair system for tricuspid valve coaptation failure | Abbott Medical Japan LLC | New device | Apr 1, 2024 | 16 mo later | 352 days | A percutaneous repair system for tricuspid valve coaptation failure that consists of a delivery system with a clip to coapt the tricuspid valve with regurgitation and a steerable guide catheter to deliver the delivery system into the right atrium. The clip is percutaneously inserted to coapt any of the anterior leaflet, septal leaflet, or posterior leaflet of the tricuspid valve, thereby reducing regurgitation from the tricuspid valve. |
| Jul 15, 2025 | Esprit BTK Everolimus-Eluting Resorbable Scaffold SystemBioabsorbable drug- eluting stent for lower extremity artery | Abbott Medical Japan LLC | New device | Apr 26, 2024 | 15 mo later | 473 days | A bioabsorbable drug-eluting stent for lower limb artery used to increase the intravascular lumen diameter of the below-the-knee arterial lesions in patients with chronic limb-threatening ischaemia (CLTI) (excluding patients on chronic dialysis). The product consists of a bioresorbable scaffold and a delivery system (rapid-exchange balloon catheter). The scaffold is coated with a cytostatic drug (everolimus) and a bioresorbable polymer. |
| Jul 3, 2025 | Peripheral Rotablator ProAtherectomy ablative angioplasty catheter | Boston Scientific Japan K.K. | New device | Sep 6, 2022K220962 | 34 mo later | 944 days | The application was submitted for the marketing approval of an atherectomy ablative angioplasty catheter to be inserted percutaneously to ablate atherosclerotic plaques and/or solid calcified below-the-knee stenotic lesions in which a balloon catheter for percutaneous transluminal angioplasty cannot pass through or cannot be expanded, thereby assisting in endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This product mainly consists of an advancer/catheter to ablate the lesions and a console to control catheter movement. |
| Jun 26, 2025 | Sphere-9 CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | New device | Oct 24, 2024 | 8 mo later | 300 days | An ablation catheter for cardiac electrophysiological mapping as well as the treatments of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, drug refractory symptomatic persistent atrial fibrillation, and common atrial flutter. It is used in combination with a dedicated generator to deliver either radiofrequency or pulsed field energy to cardiac tissue for ablation. (The original product is in the post-market performance review period.) |
| Jun 26, 2025 | Affera Ablation SystemPercutaneous cardiac coagulation/ ablation electrosurgical unit | Medtronic Japan Co., Ltd. | New device | Oct 24, 2024 | 8 mo later | 300 days | A generator of a radiofrequency and pulsed energy is intended for percutaneous myocardial catheter ablation. (The original product is in the post-market performance review period.) |
| Jun 23, 2025 | Remohab CR USoftware for cardiac exercise stress monitoring system with analytic capability | Remohab Inc. | New device | Not listed | — | 294 days | The application was submitted for marketing approval of software for cardiac exercise stress monitoring system with analytic capability intended to support the implementation of remote cardiac rehabilitation in patients with cardiovascular disease for one or multiple patients simultaneously in an online environment under the supervision of healthcare professionals. This is achieved by controlling non-active extension/traction rotary motion equipment, and providing data on the patient’s heart rate and arrhythmia. |
| Jun 12, 2025 | AutocathFFRAnalyzing software for hemodynamics or cardiac function | Medhub Ltd. | New device | Not listed | — | 470 days | This application was submitted for marketing approval of analyzing software for hemodynamics or cardiac function intended to provide fractional flow reserve (FFR) values to support the diagnosis of patients suspected of having coronary artery disease. The software calculates FFR values by automatically selecting images corresponding to the cardiac diastolic phase and containing the highest amount of contrast medium in the coronary arteries from multiple standard coronary angiographic images (DICOM data) acquired at arbitrary projection angles using an angiography system and by automatically detecting vascular stenotic lesions. |
| Jun 5, 2025 | PTeye SystemAutofluorescence detector | Medtronic Japan Co., Ltd. | New device | Not listed | — | 268 days | An autofluorescence detector that assists a surgeon in identifying the parathyroid gland that was visually specified the position by detecting autofluorescence emitted from the tissue when near infrared light is irradiated. |
| Jun 5, 2025 | Ventana DP200 Dx SystemDiagnostic assistant device for pathological whole slide image | Roche Diagnostics K.K. | New device | Not listed | — | 266 days | The application was submitted for marketing approval of a diagnostic assistant device for pathological whole slide image used for the purpose of assisting pathologists in evaluating and diagnosing high-power digital images of the entire pathological slide specimen prepared from formalin-fixed, paraffin-embedded tissue. |
| May 22, 2025 | AviClear Laser SystemDiode laser | Cutera K.K. | New device | Mar 24, 2022 | 38 mo later | 828 days | A diode laser used for the treatment of moderate to very severe acne vulgaris. The product treats acne vulgaris by reducing sebum production by means of giving damage to the sebaceous glands with heat. The results of foreign clinical studies were submitted. |
| Apr 24, 2025 | BarrigelAbsorbable tissue spacer for radiotherapy | Palette Life Sciences | New device | Not listed | — | 854 days | The application was submitted for marketing approval of an absorbable tissue spacer for radiotherapy used to reduce dose of radiation exposure to the rectum by providing space between the prostate and anterior rectal wall during radiotherapy for prostate cancer. |
| Apr 21, 2025 | Silk-Elastin Wound Healing MatrixAbsorbable dressing | Sanyo Chemical Industries, Ltd. | New device | Not listed | — | 361 days | An absorbable dressing consisting of recombinant proteins is used to heal full thickness and partial thickness wounds. The product shows a high adhesion to complicated wounds by turning silk-elastin, a recombinant protein, into a gel with the body temperature after absorbing the exudate. The product is intended to be designed to protect wounds and maintain a moist environment. Results of a Japanese clinical study were submitted. |
| Apr 15, 2025 | Mynx ControlAbsorbable topical hemostatic material | Cordis Japan G.K. | New device | Sep 2018 | 79 mo later | 355 days | An absorbable topical hemostatic material used for hemostasis at the femoral artery puncture site following percutaneous catheterization. This product is composed of a hydrogel sealant made of polyethylene glycol, bioabsorbable material, and a delivery system. The product is designed to stop bleeding by developing the hydrogel sealant to the tissue side of the vascular wall at the puncture site and closing the vascular incision site. |
| Apr 14, 2025 | Sofwave SystemUltrasonic irradiator for skin tightening | JMEC Co., Ltd. | New device | Nov 15, 2021K211483 | 41 mo later | 880 days | A device is used to improve wrinkles on the face and neck through thermocoagulation action into the dermis by irradiating ultrasound to the skin. The product is intended to improve the wrinkles of the skin by irradiating the skin with ultrasonic waves to coagulate the region mainly of the dermis at a depth of 1.5 mm from the skin surface by the thermal action. The results of foreign clinical studies were submitted. |
| Apr 4, 2025 | Evolut FX+ SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Mar 22, 2024 | 12 mo later | 294 days | A bioprosthetic valve (derived from porcine pericardium) of the prosthetic cardiac valve system used for transcatheter valve implantation. This product was developed for easier coronary intervention after transcatheter aortic valve replacement by changing the frame design of the previous-generation product “Evolut PRO+ System” (Approval No.: 30200BZX00272000) such as making 3 windows on the frame of a bioprosthetic valve. (The original product is in the post-market performance review period.) |
| Apr 4, 2025 | KanshasCatheter for balloon dilatation angioplasty | Terumo Corporation | New device | Not listed | — | 554 days | A catheter for balloon dilatation angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral and/or popliteal arteries. The balloon surface of this product is coated with paclitaxel as a drug. |
| Apr 4, 2025 | IPCLPosterior chamber lens with crystalline lens | Atworking Co., Ltd. | New device | Not listed | — | 259 days | The application was submitted for marketing approval of posterior chamber lens with crystalline lens to be inserted into an eye intended to correct visual acuity in patients with refractive errors (myopia, myopic astigmatism). |
| Mar 25, 2025 | ComfyArt One DaySingle-use colored vision corrective contact lens | APEXLENS Co., LTD. | New device | Not listed | — | 652 days | The application was submitted for marketing approval of daily wear, single-use, colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 43% and -11 2 oxygen permeability (Dk) of 60 ×10 (cm /sec)· (mLO /(mL × mmHg)). 2 |
| Mar 25, 2025 | Garmin ECG AppSoftware for home use electrocardiograph | Garmin Japan Ltd. | New device | Jan 12, 2023 | 26 mo later | 468 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating, recording, storing, transferring, and displaying a single-channel ECG similar to Lead-I ECG, as well as functions of analyzing the generated ECG, classifying the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Mar 17, 2025 | Kaneka Broncho Dilation Catheter BR- N1Endoscopic dilation catheter | Kaneka Corporation | New device | Not listed | — | 263 days | An endoscopic dilation catheter intended to secure the bronchial lumen necessary for delivering a bronchoscope to the peripheral lung fields where bronchoscopy cannot show chest abnormal shadows. It is designed to be inserted endoscopically to dilate an intrapulmonary bronchus by dilating the balloon. |
| Mar 17, 2025 | Acriva Trinova Pro ToricMultifocal posterior chamber lens | Wakamoto Pharmaceutical Co., Ltd. | New device | Not listed | — | 266 days | The application was submitted for marketing approval of a multifocal posterior chamber lens which is used to correct near, intermediate and far vision of an aphakic eye with corneal astigmatism and reduce spectacle dependence. |
| Mar 13, 2025 | LYDEX SEALANTAbsorbable tissue reinforcement material | BMG Incorporated | New device | Not listed | — | 602 days | The application was submitted for marketing approval of an absorbable tissue reinforcement material used for preventing air leakage at the surgical closure site of lung air leak. This product consists of a powder reinforcement material and a dedicated applicator used to spray the powder material. |
| Mar 7, 2025 | ELLA-BD Stent PXAbsorbable esophageal stent | Piolax Medical Devices, Inc. | New device | Not listed | — | 253 days | The application was submitted for marketing approval of an absorbable esophageal stent used for esophageal stent placement to dilate and maintain patency of refractory benign esophageal stenosis. |
| Mar 5, 2025 | Luminor 18RX Paclitaxel Eluting PTA Balloon Dilatation CatheterCatheter for balloon dilatation angioplasty | Medico's Hirata Inc. | New device | Not listed | — | 285 days | A catheter for balloon dilatation angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral or proximal popliteal arteries. The balloon surface of this product is coated with paclitaxel as a drug. |
| Feb 13, 2025 | ENDEAVORRIDESupporting software for treatment of attention- deficit/hyperactivity disorder | Shionogi & Co., Ltd. | New device | Not listed | — | 353 days | The application was submitted for marketing approval of a supporting software for treatment of attention- deficit/hyperactivity disorder used to support the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD). |
| Feb 13, 2025 | CureApp AUD A Digital Therapeutic to Reduce Alcohol ConsumptionSupporting software for treatment of alcohol dependence | CureApp Inc. | New device | Not listed | — | 329 days | The application was submitted for marketing approval of a supporting software for treatment of alcohol dependence used to support the alcohol consumption reducing therapy for patients with alcohol dependence. |
| Feb 12, 2025 | NexpowderNon-absorbable topical hemostatic material | Century Medical Inc. | New device | Sep 6, 2022K202929 | 29 mo later | 124 days | A non-absorbable hemostatic material is used to stop non-variceal gastrointestinal bleeding. The hemostatic material is sprayed to the bleeding site by the air pressure and vibration movement generated from the spray. It is then reacted with surrounding water to form a gel, which serves as a mechanical barrier. |
| Jan 17, 2025 | Fitbit ECG App.Software for home use electrocardiograph | Fitbit LLC | New device | Sep 11, 2020 | 52 mo later | 570 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating and recording an ECG wave form similar to Lead-I ECG, as well as functions of classifying the classifiable wave form into the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Dec 24, 2024 | Naida CI M90 Sound ProcessorAuditory electrical stimulator | Nihon Bionics Co., Ltd. | New device | Dec 2, 2020P960058 | 49 mo later | 264 days | The application was submitted for marketing approval of an auditory electrical stimulator used in patients with bilateral severe hearing loss who have not responded sufficiently to wearing hearing aids. |
| Dec 24, 2024 | Paroxysmal Atrial Fibrillation Feature Detection Software SmartPAFin SeriesSoftware for general- purpose electrocardiograph | Cardio Intelligence Inc. | New device | Not listed | — | 420 days | The application was submitted for marketing approval of a software for general-purpose electrocardiograph (ECG) that analyzes electrocardiographic data obtained from a general-purpose ECG, etc. and detects features of paroxysmal atrial fibrillation. The product is used to detect features of paroxysmal atrial fibrillation and examine whether additional ECGs are required. |
| Dec 17, 2024 | Hydron 1 Day PurePlusSingle-use colored vision corrective contact lens | Yung Sheng Optical Japan Co., Ltd. | New device | Dec 20, 2023 | 12 mo later | 265 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 44% and 2 oxygen permeability (Dk) of 120 × 10-11 (cm /sec)· (mLO )/[mL × mmHg]). 2 |
| Dec 17, 2024 | HUAWEI ECG ApplicationSoftware for home use electrocardiograph | Huawei Device Co., Ltd. | New device | Not listed | — | 484 days | The application was submitted for marketing approval of a software for home use electrocardiograph with functions of creating, recording, storing, transferring, and displaying a single-channel ECG similar to Lead-I ECG, as well as functions of analyzing the generated ECG, classifying the wave form suggesting sinus rhythm or atrial fibrillation, and notifying the results to the user. |
| Nov 27, 2024 | GORE TAG Thoracic Branch EndoprosthesisAortic stent graft | W. L. Gore & Associates G.K. | New device | May 2022 | 30 mo later | 302 days | A branch aortic stent graft system used for the intravascular treatment of thoracic descending aorta diseases. It has a branched stent graft structure that enables the treatment while preserving blood flow into the left subclavian artery. |
| Nov 27, 2024 | AI-Powered Software for Bacterial Infection Species Identification Assistance BiTTE-UrineSupporting software for microbial classification | NextGeM Inc. | New device | Not listed | — | 541 days | The application was submitted for marketing approval of supporting software for microbial classification. This software assists physicians in diagnosis by detecting and analyzing the characteristics of each bacterial cell based on urinary gram-stained images, and displaying the results of estimated bacterial species on the screen. |
| Nov 22, 2024 | Propel Sinus ImplantsBioabsorbable drug- eluting stent for sinus | Medtronic Japan Co., Ltd. | New device | Aug 11, 2011P100044 | 159 mo later | 357 days | A bioabsorbable drug-eluting stent for sinus is used for maintaining nasal patency after endoscopic sinus surgery for chronic rhinosinusitis. |
| Nov 18, 2024 | Vivinex Gemetric PlusPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 262 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of an aphakic eye. |
| Nov 18, 2024 | Vivinex Gemetric Plus ToricPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 262 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of aphakic eyes with corneal astigmatism. |
| Nov 8, 2024 | MANTA Vascular Closure DeviceAbsorbable topical hemostatic material with collagen | Teleflex Medical Japan, Ltd. | New device | Feb 1, 2019P180025 | 69 mo later | 366 days | An absorbable topical hemostatic material with collagen used for hemostasis at the femoral artery puncture site following percutaneous catheterization. |
| Oct 23, 2024 | PV 1DAY SiHYSingle-use colored vision corrective contact lens | Pegavision Corporation | New device | Not listed | — | 261 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens and single-use colored vision non- corrective contact lens. The lens is composed of silicone hydrogel with a water content of 60% and -11 2 oxygen permeability (Dk) of 50 × 10 (cm /sec)· (mLO /[mL × mmHg]). 2 |
| Oct 22, 2024 | Aurora EV ICD MRI DeviceAutomatic implantable defibrillator | Medtronic Japan Co., Ltd. | New device | Oct 20, 2023 | 12 mo later | 265 days | An implantable defibrillator intended to treat ventricular tachycardia that performs sensing, cardioversion, anti-tachycardia pacing therapy, and defibrillation by being implanted in the body and used in combination with a substernal implantable lead. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. |
| Oct 22, 2024 | Epsila EV MRI LeadImplantable defibrillator/pacemak er electrode/lead | Medtronic Japan Co., Ltd. | New device | Oct 20, 2023 | 12 mo later | 265 days | A substernal implantable lead to be connected to an implantable cardioverter defibrillator used for sensing, cardioversion, anti-tachycardia pacing therapy, and defibrillation for ventricular tachycardia. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. |
| Oct 15, 2024 | Amulet Left Atrial Appendage OccluderIntracardiac prosthesis | Abbott Medical Japan LLC | New device | Aug 14, 2021 | 38 mo later | 267 days | The device is an intracardiac prosthesis intended to reduce a risk of thromboembolism attributed to the left atrial appendage in patients with non-valvular atrial fibrillation who are at high risk of thromboembolism. The device consists of a closure device, a delivery catheter, and an access system. |
| Sep 30, 2024 | Osia SystemImplantable bone- conduction hearing aid | Nihon Cochlear Co., Ltd. | New device | Jul 3, 2019K190589 | 63 mo later | 854 days | The application was submitted for marketing approval of an implantable bone-conduction hearing aid to improve the ability to hear environmental sounds and speech sounds in patients with hearing impairment who have normal bone conduction thresholds or mild impairment at least in one ear. |
| Sep 30, 2024 | Apple's hearing assist FeatureSoftware for home use hearing assist fitting | Apple Inc. | New device | Sep 12, 2024 | 1 mo later | 241 days | The application was submitted for marketing approval of software for home use hearing assist fitting that allows the user to configure the sound amplification- related settings for hearing aid based on the input audiogram results. |
| Sep 30, 2024 | Apple's hearing check featureSoftware for home use audiometry device | Apple Inc. | New device | Not listed | — | 122 days | The application was submitted for marketing approval of software for home use audiometry device used to notify the user of the possibility of hearing loss by performing air conduction audiometry. |
| Sep 26, 2024 | FARASTAR ConsolePercutaneous cardiac coagulation/ ablation electrosurgical unit | Boston Scientific Japan K.K. | New device | Jan 30, 2024 | 8 mo later | 321 days | A pulse generator for pulsed field ablation procedures used for the treatment of arrhythmia. (The original product is in the post-market performance review period.) |
| Sep 26, 2024 | FARAWAVE CatheterCatheter for cardiac ablation | Boston Scientific Japan K. K. | New device | Jan 30, 2024 | 8 mo later | 321 days | A catheter intended to be used for pulsed field ablation procedure of cardiac tissues and cardiac electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. (The original product is in the post-market performance review period.) |
| Sep 19, 2024 | HemeSight Analysis ProgramSoftware for gene variants analysis (for cancer genome profiling) | Otsuka Pharmaceutical Co., Ltd. | New device | Not listed | — | 174 days | The application was submitted for marketing approval of software for gene variants analysis that outputs genomic profiles summarizing hematological malignancy-related variant information, using, as input information, the base sequence data obtained by the sequence analysis of tumor and normal specimen- derived DNA and tumor specimen-derived RNA from patients with hematological malignancies or similar diseases. The output genomic profiles are used for diagnosis, selection of treatment methods, and investigation of prognosis predictions for hematological malignancies and similar disease, based on the "Guidelines for Genomic Testing of Hematological Malignancies" established by the Japanese Society of Hematology, etc. |
| Sep 19, 2024 | Acriva Trinova ProMultifocal posterior chamber lens | Wakamoto Pharmaceutical Co., Ltd. | New device | Not listed | — | 269 days | The application was submitted for marketing approval of a multifocal posterior chamber lens which is used to correct near, intermediate and far vision of an aphakic eye and reduce spectacle dependence. |
| Sep 2, 2024 | Zeostent HGTransgastric biliary drainage stent | Zeon Medical Inc. | New device | Not listed | — | 242 days | A transgastric biliary drainage stent designed to create an anastomotic site between the gastrointestinal wall (stomach) and the bile duct in endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) for use as a drainage pathway. The product consists of a self-expanding stent with a hook-shaped anchor at the gastric wall-side distal end and a delivery system. |
| Aug 26, 2024 | CardiMax FCP-9800AiMulti-function electrocardiograph | Fukuda Denshi Co., Ltd. | New device | Not listed | — | 242 days | A multi‐functional electrocardiograph intended for ECG with 12 leads including limb leads and chest leads. The device was developed based on the "CardiMax FCP-9800" (Certification No.: 303ADBZX00038000). The change is addition of a function that estimates the possibility of paroxysmal atrial fibrillation occurring in the past 2 years. |
| Aug 26, 2024 | Apple's Sleep Apnea Notification FeatureSoftware for analysis of home use body motion information | Apple Inc. | New device | Sep 13, 2024 | 1 mo earlier | 270 days | The application was submitted for marketing approval of software for analysis of home use body motion information that analyzes wrist motion data from the built-in accelerometer of the Apple Watch to detect any irregular breathing suggestive of sleep apnea and notifies the user of it. |
| Aug 23, 2024 | RST Calculation ProgramSoftware for analysis of body motion information | HeartLab, Inc. | New device | Not listed | — | 333 days | Software for analysis of body motion information used to provide an index related to respiratory stability by analyzing nocturnal body motion data. The present application for marketing approval of the product was submitted based on the "Concept of two-step approval of Software as a Medical Device for disease diagnosis" described in the "Handling of two-step approval based on the characteristics of Software as a Medical Device" (PSB/MDED Notification No. 1116- 2 dated November 16, 2023). |
| Aug 8, 2024 | Penumbra System 4Catheter for central circulatory embolectomy | Medico's Hirata Inc. | New device | Not listed | — | 146 days | A catheter for central circulatory embolectomy used for revascularization for patients with acute ischemic stroke (in principle, within 8 hours of the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) therapy or who failed in revascularization with the t-PA therapy. A clinical evaluation report summarizing the contents of Japanese and foreign clinical literature, etc. was submitted to evaluate the efficacy and safety of ADAPT. |
| Aug 2, 2024 | TECNIS PureSee Extended Depth of Focus IOL SimplicityPosterior chamber lens with inserter | AMO Japan K.K. | New device | Not listed | — | 224 days | The application was submitted for marketing approval of a posterior chamber lens with inserter. |
| Aug 2, 2024 | TECNIS PureSee Toric Extended Depth of Focus IOL SimplicityPosterior chamber lens with inserter | AMO Japan K.K. | New device | Not listed | — | 224 days | The application was submitted for marketing approval of a posterior chamber lens with inserter. |
| Aug 2, 2024 | Endoscopic Surgery Support Program SurVis-HysSupporting software for surgical image recognition | Jmees Inc. | New device | Not listed | — | 368 days | The application was submitted for marketing approval of supporting software for surgical image recognition. This software assists surgeons with image recognition by processing image data obtained from an endoscopy system and highlighting candidate areas of the ureter and bladder during surgery. |
| Jul 29, 2024 | pRESET Stent RetrieverCatheter for central circulatory embolectomy | phenox Limited | New device | Jan 20, 2023K222848 | 18 mo later | 391 days | A catheter for central circulatory embolectomy that is intended for use to restore blood flow by removing clots from the intracranial blood vessel in patients with acute ischemic stroke (in principle, within 8 hours from the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed to restore blood flow with the t-PA therapy. The results of foreign clinical studies were submitted. |
| Jul 24, 2024 | SENTINEL Cerebral Protection SystemCentral circulatory catheter for trapping embolus | Boston Scientific Japan K.K. | New device | Jun 1, 2017 | 86 mo later | 254 days | A distal embolic protection device designed to temporarily place filters at the aortic bifurcation (brachiocephalic artery and left common carotid artery) for capturing and removing substances causing embolization during transcatheter aortic valve replacement (TAVR). |
| Jun 24, 2024 | LymmityPneumatically- powered sequential device for stimulating lymph flow | Techno Takatsuki Co., Ltd. | New device | Not listed | — | 346 days | A pneumatically-powered sequential device for stimulating lymph flow to reduce edema in patients with lymphedema by applying pneumatic compression to the affected limb and trunk. The product consists of a main unit with a built-in actuator and sleeves that compress the affected limb and trunk. As clinical evaluation data, a clinical evaluation report summarizing the literature research data on a foreign clinical study of intermittent pneumatic compression therapy with a similar product was submitted. |
| Jun 19, 2024 | Medilizer AGD SystemCerebrovascular guiding assist device | Bolt Medical, Inc. | New device | Not listed | — | 266 days | A cerebrovascular guiding assist device used to deliver an endovascular treatment device to a target lesion. The product is used in cases where the delivery of endovascular treatment devices including catheters is difficult by traditional methods due to vascular tortuosity, etc. The results of clinical studies conducted in Japan were submitted. |
| Jun 19, 2024 | PODEYE ToricPosterior chamber lens | Beaver-Visitec International Japan K.K. | New device | Not listed | — | 265 days | The application was submitted for marketing approval of a posterior chamber lens with cylindrical refractivity to be implanted in the posterior chamber of the eye to replace a cloudy crystalline lens and restore vision. |
| Jun 19, 2024 | CardiMax FCP-9900Ai SystemMulti-function electrocardiograph | Fukuda Denshi Co., Ltd. | New device | Not listed | — | 257 days | A multi-functional electrocardiograph intended for ECG with at least 12 leads including limb leads and chest leads. The device was developed based on “CardiMax FCP-9900 System” (Certification No.: 301ADBZX00034000). The change is addition of a function that estimates the possibility of paroxysmal atrial fibrillation occurring in the past 2 years. |
| Jun 12, 2024 | Kaneka Cutting Balloon Catheter CO- R1Catheter for coronary balloon dilatation angioplasty | Kaneka Corporation | New device | Not listed | — | 160 days | A balloon catheter used to dilate coronary stenosis that is difficult to dilate with a conventional balloon catheter. The balloon has integrated blades along its surface. |
| Jun 6, 2024 | Hydrus Glaucoma MicrostentIntraocular drain | Alcon Japan Ltd. | New device | Aug 10, 2018P170034 | 70 mo later | 252 days | The application was submitted for marketing approval of a stent and its delivery system used simultaneously during cataract surgery to lower intraocular pressure in patients with mild to moderate open-angle glaucoma. |
| Jun 3, 2024 | SEERSOphthalmic material for maintaining visibility | Menicon Co., Ltd. | New device | Not listed | — | 270 days | The application was submitted for marketing approval of an ophthalmic material for maintaining visibility during open surgery to treat glaucoma. The product is a prefilled syringe loaded with synthetic peptide in a clear gel formulation, which is applied to the area of observation or treatment to ensure a clear operative field and help with observation and treatment. |
| May 23, 2024 | TRUFILL n-BCA Liquid Embolic SystemCentral circulatory intravascular embolization prosthesis | Johnson & Johnson K.K. | New device | Sep 25, 2000P990040 | 284 mo later | 315 days | A central circulatory intravascular embolization prosthesis is used as an embolic agent for vascular embolization in cases where embolization is needed before surgical removal of cerebral arteriovenous malformation refractory to non-surgical approaches or in dural arteriovenous fistula that is difficult to treat sufficiently with transvenous embolization, etc. A clinical evaluation report summarizing the literature research data, etc. on the efficacy and safety of this product was submitted. |
| May 8, 2024 | Apple's Atrial Fibrillation History FeatureSoftware for home use heart rate monitor | Apple Inc. | New device | Not listed | — | 398 days | The application was submitted for marketing approval of a software for home use heart rate monitor. The device is used to analyze pulse rate data to identify episodes suggestive of atrial fibrillation, and to provide users with the estimated percentage of time that the heart showed the signs of atrial fibrillation in the past relative to the time wearing the Apple Watch. |
| May 2, 2024 | PulseSelect PFA Loop CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | New device | Dec 13, 2023 | 5 mo later | 293 days | A catheter to conduct pulsed field ablation for cardiac electrophysiological mapping and the treatments of patients with drug refractory recurrent symptomatic paroxysmal atrial fibrillation and drug refractory symptomatic persistent atrial fibrillation. (The original product is in the post-market performance review period.) |
| May 2, 2024 | PulseSelect PFA GeneratorPercutaneous cardiac coagulation/ ablation electrosurgical unit | Medtronic Japan Co., Ltd. | New device | Dec 13, 2023 | 5 mo later | 293 days | A pulse generator intended for percutaneous myocardial catheter ablation by the use of pulsed electric fields. (The original product is in the post-market performance review period.) |
| Feb 6, 2024 | MAGNETOM TerraSuperconducting magnet head/extremity imaging MRI system | Siemens Healthcare K.K. | New device | Not listed | — | 364 days | The application was submitted for marketing approval of a superconducting magnet head/extremity imaging MRI system with a static magnetic field strength of 7T that performs computer processing magnetic resonance signals related to the patient's head or extremity and presents the reconstructed imaging for medical care purposes. |
| Jan 22, 2024 | FreeStyle Libre 3Glucose monitor system | Abbott Japan LLC | New device | Not listed | — | 270 days | The application was submitted for marketing approval of a glucose monitor system that continuously measures glucose levels in the interstitial fluid. The monitored fluctuation patterns of the glucose level are displayed on the screen. |
| Dec 22, 2023 | RelivionTranscutaneous electrical nerve stimulator for the head | Sawai Pharmaceutical Co., Ltd. | New device | Feb 16, 2021 | 34 mo later | 360 days | A transcutaneous electrical nerve stimulator for the head intended for the acute treatment of migraine with or without aura. The results of foreign clinical studies were submitted. |
| Dec 22, 2023 | VARIPULSE Pulsed Field Ablation CatheterCatheter for cardiac ablation | Johnson & Johnson K.K. | New device | Not listed | — | 322 days | A multielectrode catheter is used for conducting pulsed field ablation and cardiac electrophysiological mapping for the treatment of patients with drug-refractory symptomatic paroxysmal atrial fibrillation. |
| Dec 22, 2023 | TRUPULSE GeneratorPercutaneous cardiac coagulation/ ablation electrosurgical unit | Johnson & Johnson K.K. | New device | Not listed | — | 322 days | A generator that delivers pulsed field ablation energy for percutaneous myocardial catheter ablation is used for the treatment of patients with tachyarrhythmia. |
| Dec 4, 2023 | ClotTriever Thrombectomy SystemCatheter for non- central circulatory embolectomy | Inari Medical, Inc. | New device | Feb 16, 2017K163549 | 82 mo later | 350 days | A catheter for non-central circulatory embolectomy used to restart blood flow in patients with deep vein thrombosis with severe acute symptoms excluding post-thrombotic syndrome. The results of foreign clinical studies were submitted. |
| Nov 21, 2023 | Vivinex GemetricPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 265 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of an aphakic eye. |
| Nov 21, 2023 | Vivinex Gemetric ToricPosterior chamber lens with inserter | HOYA Corporation | New device | Not listed | — | 265 days | The application was submitted for marketing approval of a posterior chamber lens with inserter in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of aphakic eyes with corneal astigmatism. |
| Nov 10, 2023 | Surpass Evolve Flow Diverter SystemCentral circulatory intravascular embolization prosthesis | Stryker Japan K.K. | New device | Jul 13, 2018P170024 | 64 mo later | 221 days | The application was submitted for marketing approval of a flow diverter system intended to be used for endovascular therapy for intracranial aneurysms that are difficult to treat surgically or by coil embolization with a maximum diameter of 10 mm or greater and wide-necked (neck part of 4 mm or greater or dome-to-neck ratio of less than 2) located from the petrous segment to the supraclinoid segment of the internal carotid artery (except for the acute ruptured aneurysms). |
| Oct 31, 2023 | Reprocessed Stabilizer G (HOGY)Reprocessed single-use organ fixation pelotte | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 456 days | A reprocessed single-use medical device originated from the existing certified device "ACROBAT-i stabilizer" (Certification No.: 224AABZX00035000), which is an organ fixation pelotte used to partially immobilize areas around the blood vessel undergoing surgery for stabilizing the anastomotic site under pulsatile conditions during cardiac surgery using sternotomy. |
| Oct 18, 2023 | PASCAL Precision SystemPercutaneous repair system for mitral valve coaptation failure | Edwards Lifesciences Limited | New device | Sep 14, 2022 | 13 mo later | 322 days | Percutaneous repair system for mitral valve coaptation failure is intended to reduce mitral regurgitation (MR) by coapting the anterior and posterior leaflets of the mitral valve using a percutaneously inserted clip. The device is indicated for degenerative mitral regurgitation (DMR). The device consists of an implant system equipped with a clip and a guide sheath set that is used to deliver the implant system to the left atrium. (The original product is in the post-market performance review period.) |
| Oct 5, 2023 | MIREVONeuropsychologic al assessment application program | Ai-BrainScience Inc. | New device | Not listed | — | 646 days | The application was submitted for marketing approval of a program to continuously collect information on patient’s gaze for use in neuropsychological assessment in order to support medical care for patients with dementia. |
| Sep 28, 2023 | Dexcom G7 CGM SystemGlucose monitor system | Dexcom, Inc. | New device | Not listed | — | 300 days | The application was submitted for marketing approval of a continuous glucose monitoring system that continuously measures glucose levels in the interstitial fluid in people with diabetes mellitus and displays the trends and the patterns of glucose fluctuation. The product is used for assisting the detection of hyperglycemia and hypoglycemia and daily self-management by people with diabetes mellitus. |
| Sep 28, 2023 | Synergy Megatron Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Jan 22, 2021 | 32 mo later | 189 days | A stent system consists of a drug-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have de novo coronary artery lesions at the length of 28 mm or less with a reference vessel diameter of 3.50-5.00 mm, and a delivery catheter to implant a stent to the target lesion. |
| Sep 25, 2023 | Tigertriever Thrombectomy DeviceCatheter for central circulatory embolectomy | Rapid Medical Ltd. | New device | Mar 23, 2021K203592 | 30 mo later | 277 days | A catheter for central circulatory embolectomy that is intended for use to restore blood flow by removing clots from the intracranial blood vessel in patients with acute ischemic stroke (in principle, within 8 hours from the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed to restore blood flow with the t-PA therapy. The results of foreign clinical studies were submitted as clinical evaluation data. |
| Aug 31, 2023 | COOK Hemospray Endoscopic Non-absorbable Hemostatic MaterialNon-absorbable topical hemostatic material | Cook Medical Japan G.K. | New device | May 7, 2018DEN170015 | 64 mo later | 251 days | A non-absorbable hemostatic material is used to stop non-variceal gastrointestinal bleeding by endoscopically inserted into the gastrointestinal tract. The product is composed of hemostatic material and the delivery system. |
| Aug 8, 2023 | Medis QFRAnalyzing software for hemodynamics or cardiac function | Medis medical imaging systems | New device | May 30, 2019 | 50 mo later | 252 days | Software that calculates QFR (Quantitative Flow Ratio) and supports the diagnosis of patients suspected of having coronary artery disease by reconstructing a three-dimensional model of the coronary artery from angiographic projections and performing numerical analyses. |
| Jul 27, 2023 | Soft Life-size 3D Cardiac ModelHeart model supporting surgical plan | crossMedical, Inc. | New device | Not listed | — | 269 days | A 3D life-size cardiac model created based on multi-slice CT image information for patients with complex congenital heart disease for which diagnosis and surgical procedure are difficult to be determined with conventional diagnostic imaging. The product is provided in order to diagnose the cardiac structure of complex congenital heart diseases for which it is difficult to diagnose or determine surgical procedures with conventional diagnostic imaging, and it is used with other medical information to support the planning of surgery. |
| Jul 11, 2023 | SYNFOLIUMSynthetic cardiovascular patch | TEIJIN MEDICAL TECHNOLOGIES CO.,LTD. | New device | Not listed | — | 169 days | A synthetic cardiovascular patch used for correction of blood flow, securing blood flow paths, and generation/reconstruction of surrounding tissues in congenital cardiac surgery. The product has an integrated structure in which a knitted fabric composed of biodegradable synthetic polymer (poly-L-lactic acid yarn) and a non-biodegradable synthetic polymer (polyethylene terephthalate yarn) is coated with a crosslinked gelatin membrane. |
| Jul 11, 2023 | Blue Radical P-01Ultrasonic periodontal scaler in combination with drugs | Luke Co., Ltd. | New device | Not listed | — | 476 days | An ultrasonic periodontal scaler in combination with drugs is used for removing dental calculus and other deposits and sterilizing the base of periodontal pockets in the treatment of patients with periodontitis at stage III or IV. The product consists of a scaler tip attached handpiece, dedicated hydrogen peroxide solution, and laser unit. |
| May 29, 2023 | Thoraflex HybridAortic stent graft | Terumo Corporation | New device | Apr 2022 | 13 mo later | 320 days | An aortic stent graft and gelatin coated vascular graft used for surgical repair in patients with aneurysms or dissections of the aortic arch and descending aorta. The aortic stent graft and gelatin coated vascular graft are sutured and integrated in advance for the purpose of simplifying the procedure. The results of foreign clinical studies were submitted as clinical evaluation data. |
| May 29, 2023 | External Ventricular Assist Device EVADSingle-use extracorporeal assistant artificial cardiac pump | Sun Medical Technology Research Corp. | New device | Not listed | — | 935 days | A single-use extracorporeal assistant artificial cardiac pump used to maintain normal systemic circulation including the heart itself and improve cardiac insufficiency in patients with severe heart failure exceeding the limit of treating with conventional medication or existing assisted circulation (such as intra-aortic balloon pumping or venoarterial bypass) due to severe heart failure or cardiogenic shock. The device consists of the internal components of the inflow cuff and outflow graft, external components such as the cannula carrying blood into and from the body, blood pump, and controller, and accessories. They are identical to those of the company's approved product "implantable Ventricular Assist System EVAHEART" (Approval No.: 22200BZX00939000) except for the cannula and tunneler. |
| May 11, 2023 | Paravalvular Leak Closure SetArtificial pericardial prosthesis | Japan Lifeline Co., Ltd. | New device | Not listed | — | 867 days | A set consisting of an occluder, pusher, and loader intended to be used for percutaneous closure of a defect hole for prosthetic paravalvular regurgitation. |
| Apr 26, 2023 | OSYPKA TMAExtracorporeal pacemaker electrode wire | Heiwa Bussan Co., Ltd. | New device | Not listed | — | 295 days | A wire-type cardiac electrode that is connected to the external pacemaker "OSYPKA DefiPace" (Approval No.: 30500BZX00068000) for temporary cardiac pacing after open heart surgery. When the product is placed in both atria, biatrial pacing and cardioversion for atrial fibrillation can be performed. |
| Apr 25, 2023 | Envi-SR Retriever for Mechanical ThrombectomyCatheter for central circulatory embolectomy | NeuroVasc Technologies, Inc. | New device | Not listed | — | 207 days | A catheter for central circulatory embolectomy intended for use to restore blood flow in patients with acute ischemic stroke in whom intravenous tissue plasminogen activator (tPA) therapy is not indicated or fails to achieve reperfusion. As clinical evaluation data, the results of clinical studies conducted in Japan were submitted. |
| Apr 20, 2023 | INDIGO SystemCatheter for central circulatory embolectomy | Penumbra, Inc. | New device | Sep 2012K121917 | 127 mo later | 115 days | The application was submitted for marketing approval of catheter for central circulatory embolectomy used to aspirate thrombus from a peripheral artery or vein. A clinical evaluation report summarizing foreign clinical studies and the contents of foreign literatures was submitted as clinical evaluation data. |
| Apr 3, 2023 | VASCADE MVPAbsorbable topical hemostatic material with collagen | Haemonetics Japan G.K. | New device | Nov 27, 2018 | 52 mo later | 264 days | The application was submitted for marketing approval of an absorbable topical hemostatic material with collagen used for hemostasis at the femoral venous access site following percutaneous catheterization. As clinical evaluation data, the results of foreign clinical studies were submitted. |
| Mar 29, 2023 | OSYPKA DefiPaceInvasive external cardiac pacemaker | Heiwa Bussan Co., Ltd. | New device | Not listed | — | 267 days | An external cardiac pacemaker for temporary atrial pacing, ventricular pacing, or atrial-ventricular sequential pacing. The product was developed based on the company's approved product "Osypka PACE300" (Approval No.: 22400BZX00123000). The major improvement is that the electrode can be placed in both atria by the combined use of the cardiac electrode, "OSYPKA TMA" (Approval No.: 30500BZX00092000) with the device so that cardioversion can be performed for atrial fibrillation. |
| Mar 28, 2023 | Kao Steam Eye Care MaskHome-use eyelid warming pack | Kao Corporation | New device | Not listed | — | 270 days | The application was submitted for marketing approval of a single-use pack to alleviate symptoms such as dry eyes and tired eyes by applying heat with steam generated by oxidation reaction of iron to the skin around the eyes. |
| Mar 27, 2023 | VENOVO Venous Stent SystemVenous stent | Medicon, Inc. | New device | Mar 13, 2019P180037 | 48 mo later | 266 days | A venous stent used to maintain the lumen of the iliofemoral vein for symptomatic iliofemoral venous outflow obstruction that is difficult to be treated with conventional therapies. The results of foreign clinical studies were submitted. |
| Feb 24, 2023 | Clareon Vivity Extended Vision IOL AutonoMe Automated Preload Delivery SystemPosterior chamber lens with inserter | Alcon Japan Ltd | New device | Jan 26, 2022 | 13 mo later | 275 days | The application was submitted for marketing approval of posterior chamber lenses with inserter preloaded with a multifocal intraocular lens which is used to correct near, intermediate, and far vision of an aphakic eye and reduce spectacle dependence. |
| Feb 15, 2023 | SUSMED Med CBT-i App for InsomniaSoftware for insomnia | Susmed, Inc. | New device | Not listed | — | 378 days | The application was submitted for marketing approval of a software for insomnia that supports cognitive behavioral therapy provided by physicians for the treatment of insomnia. |
| Feb 8, 2023 | Medtronic InceptivImplantable stimulator for pain relief | Medtronic Japan Co., Ltd. | New device | Not listed | — | 188 days | An implantable stimulator for pain relief used to relieve chronic intractable pain by applying an electrical stimulation to the spinal epidural space. A function to sense evoked compound action potentials (ECAPs) from the spinal cord (ECAP sensing) and automatically optimize the stimulus strength (neurosensing function) were installed based on the company's approved product "Intellis" (Approval No. 22900BZX00255000). ECAP sensing and neurosensing function reduce hyperstimulation and discomfort caused by the momentary approach of the distance between the spinal cord and lead, such as coughing and sneezing. The results of foreign clinical studies to evaluate the efficacy and safety of ECAP sensing and neurosensing function were submitted. |
| Jan 13, 2023 | Conamon PVP KitOrthopedic bone cement | J-Sol Medical Co., Ltd. | New device | Jun 9, 2005K042415 | 211 mo later | 276 days | An orthopedic bone cement used for percutaneous vertebroplasty. It mainly consists of a polymethyl methacrylate bone cement and instruments used for preparation (mixer, injector, and needle). The bone cement of the product is identical with the company's approved product "Mendec Spine Bone Cement Kit" (22800BZX00185000), which has approval for the indication of painful vertebral fracture due to malignant spinal tumor. The difference from the approved product is that the indication of vertebral fracture due to osteoporosis is included in addition to the indication of the approved product. |
| Dec 22, 2022 | Zilver Vena Venous StentVenous stent | Cook Medical Japan G.K. | New device | Oct 9, 2020P200023 | 26 mo later | 261 days | A venous stent used to maintain the lumen of the iliofemoral vein for symptomatic iliofemoral venous outflow obstruction that is difficult to treat with conventional therapies. The results of foreign clinical study were submitted. |
| Dec 21, 2022 | OptiLight M22 IPL modelXenon beam light therapy unit | Lumenis Be Japan K.K. | New device | Jul 26, 2021K193500 | 17 mo later | 337 days | The application was submitted for marketing approval of a xenon beam light therapy unit used to improve blood flow and relieve pain and inflammation by hyperthermia effect and for providing localized heat to the eyelids in patients with meibomian gland dysfunction. |
| Dec 20, 2022 | Aveir LPImplantable leadless cardiac pacemaker | Abbott Medical Japan LLC | New device | Mar 31, 2022 | 9 mo later | 265 days | An implantable electrode integrated cardiac pacemaker intended to be percutaneously placed in the right ventricle using a catheter. Patients in whom the device is implanted may undergo limited MRI examinations only if the patients meet the set requirements. |
| Dec 8, 2022 | Obtained 47 Brain Image Analysis Program (K121447), iSchemaView Rapid of usefulness (iSchemaView, Inc.) added in Apr. (K200760) 510(k) 510(k) inSoftware for general- purpose imaging system workstation | Not listed | New device | Not listed | — | 268 days | A software for general-purpose imaging system workstation used to assist the determination on mechanical thrombectomy in patients with acute-phase cerebral infarction based on the results of analysis on the volume of ischemic core, hypoperfusion area and their differences/ratios. |
| Nov 28, 2022 | AutoloGel SystemPlatelet-rich plasma gel preparation kit | Rohto Pharmaceutical Co., Ltd. | New device | Not listed | — | 363 days | A kit used to prepare autologous platelet-rich plasma (PRP) gel for promoting healing or covering of wounds that have not responded to conventional treatments. PRP is obtained by centrifugation of patient's own blood, and it changes from liquid to gel by mixing the drugs as components of the product. The results of a Japanese clinical study were submitted to evaluate the efficacy and safety of the product. |
| Nov 28, 2022 | Zephyr Endobronchial Valve SystemEndobronchial valve | Pulmonx Corporation | New device | Jun 29, 2018P180002 | 53 mo later | 347 days | An endobronchial valve used in patients who have severe chronic obstructive pulmonary disease with severe emphysema and hyperinflation and are receiving optimal non-invasive treatment and also whose physiological examination shows little to no collateral ventilation between adjacent pulmonary lobes. The results of foreign clinical studies were submitted. |
| Nov 25, 2022 | Agent Paclitaxel-coated Balloon CatheterCatheter for coronary balloon dilatation angioplasty | Boston Scientific Japan K.K. | New device | Not listed | — | 224 days | A catheter for coronary balloon dilatation angioplasty used to inhibit restenosis in revascularization for coronary in-stent restenosis and de novo coronary lesions. |
| Oct 27, 2022 | NanoZoomer S360MD Slide scanner systemDiagnostic assistant device for pathological whole slide image | Hamamatsu Photonics K.K. | New device | Not listed | — | 268 days | The application was submitted for marketing approval of a diagnostic assistant device for pathological whole slide image, which is intended to assist pathologists to evaluate and diagnose high magnification digital images of whole pathological slide samples. This product automatically creates, displays, and stores pathological whole slide images. |
| Oct 18, 2022 | Svelte Sirolimus-eluting Coronary Stent SystemCoronary stent | Svelte Medical Systems, Inc. | New device | Dec 13, 2021P210014 | 10 mo later | 263 days | A stent system consisting of a sirolimus-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo native coronary artery lesion (a lesion length of 34 mm or less) with a reference vessel diameter of 2.25-4.00 mm, and a delivery catheter to implant the stent to the site of stenosis. |
| Oct 14, 2022 | Radiation Dermatitis Film-forming Material StrataXRTLocal control hydrogel dressing | Toyo Medic Co., Ltd. | New device | Not listed | — | 261 days | A local control hydrogel dressing made of silicone gel used to reduce skin disorders caused by irradiation and promote healing. The product was developed to cover the inflammatory area and maintain a moist environment for the purpose of promoting healing of radiation dermatitis. A clinical evaluation report summarizing foreign clinical literatures, etc. was submitted to evaluate that this product is effective in suppressing or improving the severity of radiation dermatitis and that there are no risks of adverse events specific to this product. |
| Oct 12, 2022 | ENROUTE Transcarotid Neuroprotection SystemCentral circulatory catheter for trapping embolus | Silk Road Medical, Inc. | New device | Mar 10, 2016K153485 | 79 mo later | 512 days | A device used to prevent embolization by transcarotid vascular access during carotid angioplasty and stent placement in patients with carotis stenosis. The results of foreign clinical study were submitted. |
| Oct 12, 2022 | ENROUTE Transcarotid Stent SystemCarotid artery stent | Silk Road Medical, Inc. | New device | May 18, 2015P140026 | 89 mo later | 512 days | A stent system is used for extending and maintaining the vascular lumen through a transcarotid approach to be inserted and placed in the site of stenosis in the cervical carotid artery (common carotid artery, internal carotid artery). The results of foreign clinical study were submitted. |
| Oct 11, 2022 | Airy One DaySingle-use colored vision corrective contact lens | HOYA Corporation | New device | Not listed | — | 224 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens, which is intended to be used for visual correction. The lens is composed of silicone hydrogel with a water content of 48% and an oxygen permeability (Dk) of 112 -11 2 × 10 (cm /sec)·(mLO /[mL × mmHg]). 2 |
| Oct 11, 2022 | hoyaONE treasuredSingle-use colored vision corrective contact lens | HOYA Corporation | New device | Not listed | — | 224 days | A product with multiple brand name of "Airy One Day." |
| Sep 29, 2022 | Syringe Pump Control Software for Assisting Total Intravenous AnesthesiaSoftware for automated drug delivery for general anesthesia | Nihon Kohden Corporation | New device | Not listed | — | 363 days | The application was submitted for marketing approval of a software that controls the dose of sedatives, analgesics, and muscle relaxants by controlling the concomitantly used syringe pumps under the supervision of anesthesiologists in surgeries in which general anesthesia is provided with intravenous anesthetics. |
| Sep 20, 2022 | Avansee Preload1P ToricPosterior chamber lens with inserter | Kowa Company, Ltd. | New device | Not listed | — | 267 days | The application was submitted for marketing approval of posterior chamber lens with inserter having cylindrical refractivity, which is intended to be used for visual correction of corneal astigmatism. |
| Sep 9, 2022 | C2 CryoBalloon Ablation SystemGeneral-purpose cryosurgical unit | HOYA Corporation | New device | Sep 29, 2010 | 143 mo later | 528 days | A general-purpose cryosurgical unit for endoscopic cryoablation of lesion tissue in patients with Barrett's esophageal lesion associated with dysplasia or non- invasive adenocarcinoma. The product consists of a balloon catheter and a controller that sprays and exhausts nitrous oxide gas. By spraying nitrous oxide gas into the balloon, cryoablation can be provided to the lesion based on the principle of adiabatic expansion. A clinical evaluation report was submitted to evaluate the clinical efficacy and safety of cryoablation of lesions. |
| Sep 9, 2022 | ApajetTooth surface coating spray device | Sangi Co., Ltd. | New device | Not listed | — | 247 days | A tooth surface coating spray device with which the tooth surface is coated with hydroxyapatite layer to suppress hypersensitivity of dentin or formed dentin and reline the cavity containing dentin. The results of Japanese clinical studies conducted to verify the efficacy and safety based on novelty of the principle of coating the tooth surface by spraying the dedicated powder were submitted. |
| Sep 6, 2022 | Coolief Radiofrequency Pain Management SystemElectrosurgical unit for cardiac ablation | Avanos Medical Japan Inc. | New device | Jun 8, 2007K163236 | 183 mo later | 258 days | An electrosurgical unit for ablation to treat pain by supplying a high-frequency current to the peripheral nerve to warm and coagulate (cauterize) the nerve in patients with chronic pain associated with knee osteoarthritis who are not candidates for orthopedic surgery and do not respond to conventional conservative therapy. The product can also be used to treat chronic pain of the face, neck, and back. The results of foreign clinical studies in which the effectiveness of product was compared with that of adrenocorticosteroid injection for pain relief in patients with chronic knee pain due to knee osteoarthritis were submitted. |
| Sep 6, 2022 | FINEVISION HPMultifocal posterior chamber lens | Beaver-Visitec International Japan K.K. | New device | Not listed | — | 253 days | The application was submitted for marketing approval of a multifocal posterior chamber lens to be inserted as a substitute for the crystalline lens in the posterior chamber to correct near, intermediate, and far vision of an aphakia eye. |
| Sep 1, 2022 | Reprocessed Steerable Electrode Catheter (Stryker Japan)Reprocessed cardiac catheter-tip electrode | Stryker Japan K.K. | New device | Jul 9, 2008 | 170 mo later | 505 days | A reprocessed single-use medical device originating from “Inquiry Catheter” (Approval No. 21600BZY00253000), which is a cardiac catheter-tip electrode and is used placed percutaneously and transluminally in the heart to perform a cardiac electrophysiological study and temporary pacing. |
| Aug 26, 2022 | PENTAS StentCentral circulatory intravascular embolization prosthesis | PENTAS Inc. | New device | Not listed | — | 268 days | A self-expandable assist stent used to prevent a coil mass from protruding into and dropout from the parent artery during the coil embolization treatment in patients with a parent artery with a diameter of 2.5-4.6 mm among patients with unruptured cerebral aneurysm (the maximum diameter of 5 mm or greater) that are difficult to be treated with surgery or coil embolization with embolic coil alone and wide-necked (neck part of 4 mm or greater or dome-to-neck ratio of less than 2). The product was developed as a stent expected to have the maximum blood flow suppression effect with the minimum metal area. An available treatment planning program is included to supplementally support the stent placement. The results of Japanese clinical studies were submitted as clinical evaluation data. |
| Aug 19, 2022 | TVC NIRS CatheterCentral circulation system intravascular near-infrared catheter | Goodman Co., Ltd. | New device | Apr 12, 2019K183599 | 40 mo later | 435 days | A catheter with a near-infrared spectroscopy (NIRS) function using NIRS to detect lipid core plaque in the vascular wall. This device provides imaging information for diagnosis. NIRS function presents one of the risk factors associated with major cardiovascular events. At the same time, the shape and characteristics of the central circulatory vascular lumen and vascular wall are visualized with ultrasound to provide diagnostic image information. The results of foreign clinical studies were submitted. |
| Aug 17, 2022 | Reprocessed Saw Blade S (HOGY)Reprocessed single- use surgical saw | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 294 days | Reprocessed single-use medical device originating from the existing certified device, "Stryker Bone Saw Blade" (226AFBZX00019000), which is a surgical saw for cutting or separating anatomical structure. |
| Aug 2, 2022 | M-DES Coronary StentCoronary stent | Nipro Corporation | New device | Not listed | — | 260 days | A stent system consisting of a sirolimus-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo native coronary artery lesion (a lesion length of 32 mm or less) with a reference vessel diameter of 2.5-4.25 mm and a delivery catheter used to implant the stent to the site of stenosis. The results of a Japanese clinical study were submitted for evaluation of the efficacy and safety of the product. |
| Jul 4, 2022 | Niti-S EUS-BD SystemTransgastric biliary drainage stent | Century Medical, Inc. | New device | Not listed | — | 193 days | The product is a stent for maintaining the drainage route between the punctured gastrointestinal tract and bile duct in endoscopic ultrasound-guided biliary drainage (EUS-BD). The application was submitted to expand the indication of the company’s approved product "Niti-S Biliary Silicone Covered Stent (Approval No.: 22200BZX00699000)" to EUS-BD. The clinical evaluation report on the treatment outcome of EUS-BD using the product was submitted. |
| Jun 9, 2022 | ReDS Pro SystemElectromagnetic component analyzer | Century Medical, Inc. | New device | Aug 2015K150095 | 82 mo later | 224 days | A device to provide the lung fluid composition ratio by measuring the lung fluid content using electromagnetic waves, consisting of a console, a sensor unit, etc. The device was developed for the intention of the use as an auxiliary positioning in the treatment of heart failure by monitoring the lung fluid composition ratio quantitatively measured with this device. As the clinical evaluation data, the clinical evaluation report summarizing the contents of clinical literatures, etc. was submitted. |
| Jun 7, 2022 | Reprocessed Intracardiac Ultrasound Catheter V (Stryker Japan)Remanufactured central circulatory intravascular ultrasound catheter | Stryker Japan K.K. | New device | May 8, 2019 | 37 mo later | 442 days | A catheter for imaging of structure and blood flow of the heart, etc. with a built-in transducer whose tip transmits/receives ultrasound. The product is a reprocessed single-use medical device originating from "ViewFlex Xtra ICE Catheter" (Approval No.: 22600BZX00091000). |
| Jun 2, 2022 | COVID-19 Pneumonia Analysis Program SCO-PA01Software for diagnostic X-ray imaging system workstation | Canon Medical Systems Corporation | New device | Not listed | — | 98 days | The application was submitted for marketing approval of a computer detection support software which processes the image information of the lungs obtained from the X- ray computed tomography system, and is used to present reference information on the possibility of containing characteristic findings of COVID-19 pneumonia in the CT image when performing the image diagnosis of pneumonia. |
| May 18, 2022 | GORE Cardioform Septal OccluderArtifitial pericardial prosthesis | W. L. Gore & Associates G.K. | New device | Mar 30, 2018P050006 | 50 mo later | 359 days | This product is a percutaneous, transcatheter patent foramen ovale (PFO) closure device. This treatment is intended to close the PFO to reduce the risk of recurrence of ischemic stroke in patients who have had a cryptogenic stroke with possible involvement of a PFO due to a presumed paradoxical embolism. Data from the results of foreign clinical studies were submitted. |
| Apr 26, 2022 | nodocaEndoscopic telescope | Aillis, Inc. | New device | Not listed | — | 322 days | A system used as an aid in the diagnosis of influenza virus infection by photographing pharynx and analyzing findings of pharynx such as lymph tissue on the images (including the tonsils and lymph follicles) and clinical data to detect findings, symptoms, etc. characteristic to influenza virus infection. It is not intended to make a definitive diagnosis based only on the analysis results of this product. |
| Apr 26, 2022 | CureApp HT Digital Therapeutic App for Hypertension Adjunctive TreatmentSupporting software for hypertension treatment | CureApp Inc. | New device | Not listed | — | 334 days | The application was submitted for marketing approval of a supporting software for hypertension treatment used to support the treatment of hypertension by helping to modify lifestyle in the treatment of hypertension in patients with essential hypertension. |
| Apr 14, 2022 | Excimer Laser Turbo Power CatheterLaser angioplasty catheter | Philips Japan Ltd. | New device | Not listed | — | 363 days | A laser angioplasty catheter used in percutaneous endovascular treatment for lesions of restenosis or reocclusion that occur within a stent placed in the femoropopliteal artery. The product is used with an exclusive laser console, “Excimer Laser Angioplasty Device” (Approval No. 21300BZY00528000), and is used an atherectomy device used to treat stenosis of lesions by vaporizing the tissue with limited heat damage to the surroundings using an excimer laser at a wavelength of around 308 nm. |
| Apr 7, 2022 | Medicarbo Hip NailImplantable femur intramedullary fixation nail | B.I.TEC Co., Ltd. | New device | Not listed | — | 765 days | An implantable femur intramedullary fixation nail that is inserted into the medullary cavity of the femur for fixation or stabilization of fracture of the base of the femoral neck or trochanteric femoral fracture. Carbon fiber reinforced PEEK resin is used as the raw material for the nail and lag screw body contained in the component. The results of a Japanese clinical study conducted as a multicenter, single-arm, open-label design were submitted to evaluate the performance of this product for bone union as well as malfunctions and adverse events. |
| Mar 31, 2022 | BioFreedom Ultra Drug-coated StentCoronary stent | Biosensors Japan Co., Ltd. | New device | Not listed | — | 489 days | A stent system consisting of a biolimus-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo coronary artery lesion (a lesion length of 33 mm or less) with a reference vessel diameter of 2.5-4.0 mm and a delivery catheter used to implant the stent to the site of stenosis. As clinical evaluation data, the results of foreign clinical studies were submitted. |
| Mar 28, 2022 | IVL GeneratorDriving unit for angioplasty athelectomy catheter | Shockwave Medical, Inc. | New device | Feb 12, 2021 | 13 mo later | 363 days | A generator used to disrupt severely calcified de novo coronary artery lesions. As clinical evaluation data, the results of foreign clinical studies and Japanese studies were submitted. |
| Mar 28, 2022 | C Coronary IVL CatheterAtherectomy ablative angioplasty catheter | Shockwave Medical, Inc. | New device | Feb 12, 2021 | 13 mo later | 363 days | A catheter used to disrupt severely calcified de novo coronary artery lesions. As clinical evaluation data, the results of foreign clinical studies and Japanese studies were submitted. |
| Mar 28, 2022 | GORE Excluder Conformable AAA Stent Graft SystemAortic stent graft | W. L. Gore & Associates G.K. | New device | Dec 22, 2020 | 15 mo later | 364 days | An aortic stent graft used for the intravascular treatment of infrarenal abdominal aortic aneurysm (including aneurysms extending from the abdominal aorta to the iliac artery) that satisfies the specific anatomical requirements. The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Mar 28, 2022 | EIT Monitor PulmoVista 500Respiratory function measuring system | Draeger Japan Ltd. | New device | Not listed | — | 238 days | The application was submitted for marketing approval of a respiratory function measuring system which displays information on changes in lung volume and local distribution in the internal electrode surface by measuring the biological impedance distribution in the chest using electric impedance tomography technology. This product displays the tomographic image data related to impedance changes in real time and analyzes the data. |
| Mar 14, 2022 | REGENETEN ImplantCollagen- containing absorbable tendon regeneration material | Smith & Nephew KK | New device | Mar 26, 2014 | 96 mo later | 391 days | A collagen containing absorbable tendon regeneration material that manages and protects tendons with oriented collagen fibers that act as a scaffold for tendon tissue, in order to promote repair of a cuff injury site without substantial loss of tissue. A clinical evaluation report organizing the results of non-GCP-compliant foreign clinical studies and clinical literatures, etc. was submitted to evaluate the facts that this product contributes to the repair of the cuff such as a tendency towards increased tendon thickness and that the risks associated with the use of this product are acceptable for the efficacy. |
| Feb 24, 2022 | Preserflo MicroShunt Glaucoma Drainage System Core KitIntraocular drain | Santen Pharmaceutical Co., Ltd. | New device | Not listed | — | 269 days | The application was submitted for marketing approval of an intraocular drain used to reduce intraocular pressure in patients with glaucoma whose intraocular pressure can not be sufficiently reduced by treatments including drug and laser therapies. |
| Feb 17, 2022 | RECELL Autologous Cell Harvesting and Non-cultured Cell Suspension Preparation KitAutologous skin cell grafting kit | Cosmotec Co., Ltd. | New device | Sep 20, 2018 | 41 mo later | 360 days | An autologous skin cell grafting kit intended to produce a non-cultured cell suspension from a skin specimen collected from a patient and promote healing of the wound of acute burn and donor sites. The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Feb 10, 2022 | Phototherapy Device for Pigmentary Skin Disease NordlysPhototherapy device for skin diseases | Syneron Candela K.K. | New device | Jul 15, 2015 | 79 mo later | 182 days | A phototherapy device for skin diseases used to treat benign superficial skin pigmentary disease by thermal action of continuous spectral light from visible to infrared rays using intense pulsed light. A clinical evaluation report summarizing clinical literatures, etc. on the previous generation product of this device and similar products of other companies was submitted to evaluate the improvement effect on pigmentary disease and the acceptability of anticipated adverse events for the efficacy. |
| Feb 8, 2022 | Celution Cell Therapy Kit SUIAdipose tissue separation kit | Cytori Therapeutics, K.K. | New device | Sep 28, 2006K060482 | 184 mo later | 776 days | An adipose tissue separation kit to clean, separate, and process adipose tissue by centrifugation to be administered specific cells and adipose tissue for the treatment of patients who have not responded or have not sufficiently responded to behavioral therapy or drug therapy for mild to moderate male stress urinary incontinence associated with urethral sphincter incompetence secondary to a surgery for prostatic hyperplasia or prostate cancer. The results of Japanese clinical studies were submitted to evaluate the efficacy and safety of the treatment using this product. |
| Feb 8, 2022 | AQUABEAM Robotic SystemSurgical robot unit | PROCEPT BioRobotics Corporation | New device | Dec 21, 2017DEN170024 | 50 mo later | 229 days | A device to resect an enlarged prostate by inserting a handpiece transurethrally and using a high-pressure water injection of physiological saline. A physician sets a resection plan preoperatively, and the robot system performs treatment following the plan. The application was submitted for marketing approval of a medical device used for resection and removal of prostate tissue of male patients with lower urinary tract symptoms associated with prostatic hyperplasia. |
| Jan 20, 2022 | aitAlternating magnetic field therapy device | Peace of Mind Co., Ltd. | New device | Not listed | — | 269 days | The application was submitted for marketing approval of an alternating magnetic field therapy device used to relieve pain by transcutaneously irradiating 2 types of alternating magnetic fields and stimulating the nerves. |
| Jan 17, 2022 | Navitor Transcatheter Aortic Valve Implantation SystemTranscatheter bovine cardiac valve | Abbott Medical Japan LLC. | New device | Not listed | — | 292 days | A self-expandable percutaneous aortic bioprosthetic valve system for a percutaneous aortic valve replacement used in symptomatic patients with severe aortic valve stenosis attributed to calcification and degeneration of the native aortic valve cusps, who are not eligible for surgery and of which this treatment is considered as their best therapeutic option. This product consists of a self-expanding bioprosthetic valve, delivery system, and loading system. As clinical evaluation data, the results of foreign clinical studies were submitted. |
| Jan 7, 2022 | Acumen HPI SystemMultiparameter monitor | Edwards Lifesciences Limited | New device | Nov 16, 2018K180881 | 38 mo later | 266 days | The application was submitted for marketing approval of a multiparameter monitor to measure hemodynamics such as thermodilution cardiac output and arterial pressure-based cardiac output and to collect and monitor various biological information. |
| Dec 24, 2021 | HOPE LifeMark-CAD Pneumonia Image Analysis Program for COVID- 19Software for diagnostic X-ray imaging system workstation | Fujitsu Japan Limited | New device | Not listed | — | 60 days | The application was submitted for marketing approval of a computer detection support software which processes the image information of the lungs obtained from the X-ray computed tomography system, and is used to present reference information on the possibility of containing characteristic findings of COVID-19 pneumonia in the CT image when performing the image diagnosis of pneumonia. |
| Dec 24, 2021 | Reprocessed cuff C (HOGY)Reprocessed cuff for pneumatically- powered massager | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 267 days | Reprocessed single-use medical device originating from the component of “SCD 700 Series” (Certification No.: 223AABZX00029000), which is a cuff for a pneumatically-powered massager used to prevent venous thrombosis by promoting venous blood circulation. |
| Dec 20, 2021 | Total 14Reusable colored vision corrective contact lens | Alcon Japan Ltd. | New device | Not listed | — | 264 days | The application was submitted for marketing approval of daily wear, reusable colored vision corrective contact lens, which is intended to be used for visual correction. The lens is composed of silicone hydrogel (Lehfilcon A) with a moisture content of 55% and an oxygen permeability (Dk) -11 2 of 123 x 10 (cm /sec)·(mLO /[mL × mmHg]). 2 |
| Dec 17, 2021 | NasalezeHome-use nasal mucosal protector | Nasaleze Limited | New device | Dec 31, 2013 | 96 mo later | 267 days | The application was submitted for marketing approval of a home-use nasal mucosal protector used for alleviation of symptoms associated with allergic rhinitis (sneezing, runny nose, and stuffy nose). |
| Dec 13, 2021 | Motiva Breast ImplantsGel-filled mammary prosthesis | Establishment Labs S.A. | New device | Not listed | — | 269 days | A gel-filled mammary prosthesis made of a silicone gel used for breast reconstruction or augmentation in adult women to restore or form the shape of a breast. This product contains SmoothSilk Series implant and SmoothSilk Ergonomix Series implant as components, both of which are round in shape and have a smooth surface finish. A clinical evaluation report consisting of data related to foreign clinical study and clinical publications was submitted to prove there are not unacceptable risks of product- specific adverse events. |
| Nov 30, 2021 | Wire for Lymphatic VesselsNon-vascular guidewire | TRS Co., Ltd. | New device | Not listed | — | 179 days | The application was submitted for marketing approval of a non-vascular guidewire used to be inserted into the lymphatic vessels to confirm their courses, locations, etc. in lymphatic-venous anastomosis for treatment of lymphoedema. A clinical evaluation report summarizing literatures, etc. on lymphatic-venous anastomosis at the sites where this product is expected to be used was submitted. |
| Nov 29, 2021 | RelayPro Thoracic Stent Graft SystemAortic stent graft | Terumo Corporation | New device | Not listed | — | 301 days | The application was submitted for marketing approval of an arterial stent graft used for the endovascular treatment of descending thoracic aortic aneurysm. The product was designed based on the company’s approved product "Relay Plus Thoracic Stent Graft System" (Approval No. 22500BZX00160000) and for which different stent graft types were added and the delivery system was improved. The results of physicochemical characterization tests, biological safety test, durability test, animal test, and clinical studies were submitted to secure the application content. |
| Nov 22, 2021 | Impella 5.5 SmartAssistControler for temporary non- roller type cardiac support blood pump | Abiomed, Inc. | New device | Sep 24, 2019 | 26 mo later | 270 days | A catheter-based blood pump that assists systemic circulation in patients with drug resistant acute heart failure, such as cardiogenic shock, can be inserted through axillary/subclavian artery and placed in the left ventricle. This device removes blood directly from the left ventricle and sends the blood from the catheter into the ascending aorta. The product is concomitantly used with a dedicated driving device “Impella Controller” (Approval No.: 22800BZX00031000). This product was developed with the aim of limiting the insertion site to the axillary/subclavian artery according to the clinical needs, increasing the circulatory support flow, and reducing the size of the catheter pump based on the approved "Impella Circulatory Assist Pump Catheter" (Approval No.: 228000BZI00032000). A clinical evaluation report summarizing the contents of clinical literatures, etc. was submitted as the data for clinical evaluation of the product. |
| Oct 27, 2021 | Octopal R Pulse Oximeter DMO- 8000Pulse oximeter | Nihon Kohden Corporation | New device | Not listed | — | 359 days | This application was submitted for marketing approval of a pulse oximeter that has a function of measuring patients’ vital signs (percutaneous arterial oxygen saturation, carboxyhemoglobin concentration, methemoglobin concentration, and pulse rate), displaying them on the screen, and issuing an alarm. |
| Oct 27, 2021 | TenaleafAbsorbable adhesion- prevention dressing | GUNZE LIMITED | New device | Not listed | — | 245 days | A sheet-type absorbable adhesion-prevention dressing to reduce the frequency, extent, and severity of postoperative adhesions in patients undergoing surgery of abdominal or pelvic cavity. The product becomes gel by absorbing water in the damaged site or abdominal cavity, prevents formation of fibrin networks in the damaged site and surrounding tissues as a physical barrier, and exerts an adhesion-reducing effect. |
| Oct 26, 2021 | Jetstream Atherectomy SystemAtherectomy ablative angioplasty catheter | Boston Scientific Japan K.K. | New device | Apr 10, 2013 | 103 mo later | 356 days | The application was submitted for marketing approval of a catheter system used to remove hard atherosclerotic disease and stenosis in the superficial femoral artery and/or proximal popliteal artery to facilitate pre-dilation of severely calcified lesions (excluding in-stent restenosis lesions) that do not pass through or are difficult to dilate with a PTA balloon catheter used for pre-dilatation prior to drug-coated balloons. |
| Oct 26, 2021 | EluNIR Drug-Eluting StentCoronary stent | Medinol Ltd. | New device | Nov 2017P170008 | 47 mo later | 971 days | A coronary stent used for the treatment of patients with symptomatic heart disease who have de novo native coronary artery lesions (a lesion length of 42 mm or less) with a reference vessel diameter of 2.50-4.25 mm. The results of foreign and Japanese clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Oct 14, 2021 | 1day SD01H-SSingle-use colored vision corrective contact lens | SEED Co., Ltd. | New device | Not listed | — | 269 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens, which is intended to be used for visual correction. The lens is composed of silicone hydrogel with a water content of 68% -11 and an oxygen permeability (Dk) of 60 x 10 2 (cm /sec)·(mLO /[mL × mmHg]). 2 |
| Oct 13, 2021 | Rezum SystemWater vapour delivery system for prostatic tissue | Boston Scientific Japan K.K. | New device | Aug 27, 2015K150786 | 74 mo later | 359 days | A water vapour delivery system for prostatic tissue indicated for dysuria associated with prostatic hyperplasia. In the system, a needle in the delivery device is inserted into the site of enlarged prostate and the high-temperature water vapour is delivered from the holes of the needle tip. The system uses the thermal energy released from the liquefaction of the water vapour injected from the needle tip, to necrotise the enlarged prostate tissue with time, and improves dysuria. The results of a foreign clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Oct 5, 2021 | Ultimaster NagomiCoronary stent | Terumo Corporation | New device | Not listed | — | 256 days | A stent system consisting of a drug-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have de novo native coronary artery lesions (a lesion length of 45 mm or less) with a reference vessel diameter of 2.25-4.0 mm, and a delivery catheter used to implant a stent to the target lesion. The results from a subgroup analysis of global clinical study data using the previous generation product of this product “Ultimaster” (Approval No.: 22700BZX00224000) were submitted to evaluate the efficacy and safety of this product. |
| Sep 17, 2021 | Medtronic MiniMed 700 SeriesPortable insulin infusion pump | Medtronic Japan Co., Ltd. | New device | Sep 1, 2020 | 13 mo later | 340 days | The application was submitted for marketing approval of a glucose monitoring system used for continuous subcutaneous infusion of basal insulin at a selectable rate and bolus infusion of insulin at a selectable dose. |
| Aug 26, 2021 | DiamondTemp Ablation CatheterCatheter for cardiac ablation | Medtronic Japan Co., Ltd. | New device | Jan 28, 2021 | 7 mo later | 269 days | An electrode catheter to be used for conducting cardiac electrophysiological mapping, and percutaneous cardiac ablation with high-frequency current for the treatment of patients with drug- resistant recurrent symptomatic paroxysmal atrial fibrillation and common type atrial flutter. The results of foreign clinical studies were submitted as clinical evaluation data . |
| Aug 23, 2021 | Harmony Transcatheter Pulmonary Valve Replacement SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Mar 26, 2021 | 5 mo later | 266 days | A transcatheter porcine pericardial valve used in patients with severe pulmonary regurgitation who have a medical history of surgical repair of the right ventricular outflow tract or transcatheter intervention (balloon valvuloplasty) and for whom pulmonary valve replacement is clinically required. The results of a global clinical study were submitted to evaluate the efficacy and safety of the product. |
| Aug 6, 2021 | Oncotype DX Breast Recurrence Score ProgramSoftware program to support tumor malignancy determination | Exact Sciences K.K. | New device | Not listed | — | 340 days | The application was submitted for marketing approval of a software program to support tumor malignancy determination which outputs a Recurrence Score that assists in determining chemotherapy use based on the RNA expression levels of 21 genes in tumor tissue of hormone receptor-positive, HER2-negative, early-stage invasive breast cancer patients. |
| Jul 21, 2021 | POLARx Cryoablation Balloon CatheterCatheter for cardiac ablation | Boston Scientific Japan K.K. | New device | Not listed | — | 250 days | A balloon catheter used for cryoablation of cardiac tissue in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Jul 14, 2021 | Opalescence GODrug-containing dental tooth surface cleaner auxiliary material | ULTRADENT PRODUCTS, INC. | New device | Not listed | — | 226 days | A drug-containing dental tooth surface cleaner auxiliary material whose ready-made tray is pre- filled with 6% hydrogen peroxide. This product is used by patients on their teeth at home, etc., under the management of a dentist. The results of a Japanese clinical study designed as a multicenter, open-label controlled study were submitted to evaluate the efficacy and safety of the product. |
| Jun 17, 2021 | GORE Cardioform ASD OccluderArtifitial pericardial prosthesis | W. L. Gore & Associates G.K. | New device | May 28, 2019 | 25 mo later | 261 days | An artifitial pericardial prosthesis used to percutaneously close ostium secundum atrial septal defect. The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product. |
| Jun 16, 2021 | TNS Alloy StemFemoral component for hip prosthesis | Mizuho Corporation | New device | Not listed | — | 266 days | A femoral component for hip prosthesis used for total hip replacement or prosthesis replacement in patients with hip joint functional disorders including osteoarthritis, rheumatoid arthritis and necrosis of the femoral head. The product has only a direct fixation type of femoral stem, and is used with an approved stem head. The product is made from Ti-Nb-Sn alloy, and obtains elastic gradient from proximal to distal by thermal processing of the base material. The results of a Japanese clinical study designed as a single-arm, open-label, multicenter study were submitted to evaluate the improvement in JOA hip score after surgery as efficacy and malfunctions and adverse events as safety. |
| Jun 11, 2021 | Week Fresh View SReusable colored vision corrective contact lens | Rohto Pharmaceutical Co., Ltd. | New device | Not listed | — | 248 days | The application was submitted for marketing approval of daily wear, reusable colored vision corrective contact lens, which is intended to be used for visual correction. The lens is composed of silicone hydrogel (toufilcon B) with a moisture content of 50% and an oxygen permeability (Dk) -11 of 91×10 (cm2/sec)·(mLO /[mL x mmHg]). 2 |
| Jun 7, 2021 | EpiFixTissue-healing promoting material using human amniotic membrane | MiMedx Group, Inc. | New device | Not listed | — | 363 days | A tissue-healing promoting material composed of human amniotic membranes intended to promote wound healing in patients with refractory ulcers who have not responded to conventional therapies. The product is made of dried human amniotic/chorionic membranes obtained from the human placenta, prepared by cleaning, drying, and sterilizing, and contains multiple types of amniotic/chorionic membrane-derived extracellular matrix proteins, growth factors, cytokines, etc. A clinical evaluation report primarily consisting of the results of a foreign post-marketing clinical study, a literature review, and an adverse event report was submitted to evaluate the efficacy and safety of the product as a tissue-healing promoting material. |
| May 26, 2021 | RENASYS Abdominal KitOpen abdominal wound dressing kit | Smith & Nephew KK | New device | Nov 22, 2011 | 114 mo later | 321 days | The application was submitted for marketing approval of a dressing kit intended to facilitate early closure of the peritoneum. The product provides the protection of abdominal contents from external environment, efficient drainage, suppression of inflammation, and alleviation of edema by covering the organs inside the abdomen and applying controlled negative pressure in the case where open abdominal wounds are accompanied by exposure of abdominal organs and also abdominal closure by primary suture is difficult. The product consists of an organ protective layer, form filler, drape, and soft port. An approved product, “RENASYS Wound Therapy System” is used in combination with the product for negative pressure control. |
| May 26, 2021 | COVID-19 Pneumonia Image Analysis Program FS-AI693Software for general-purpose imaging system workstation | FUJIFILM Corporation | New device | Not listed | — | 65 days | The application was submitted for marketing approval of a computer detection support software which processes the image information of the lungs obtained from the X-ray computed tomography system, and is used to present reference information on the possibility of containing characteristic findings of COVID-19 pneumonia in the CT image when performing the image diagnosis of pneumonia. |
| May 13, 2021 | ALTO Abdominal Stent Graft SystemAortic stent graft | Endologix LLC | New device | Mar 13, 2020 | 14 mo later | 364 days | The application was submitted for marketing approval of a stent graft system for the treatment of abdominal aorta that obtains adhesion to blood vessels by filling polymer. |
| May 11, 2021 | Bausch & Lomb Aqualox One Day UV ShinSingle-use colored vision corrective contact lens | Bausch & Lomb Japan Co., Ltd. | New device | Jun 2, 2020 | 11 mo later | 242 days | The application was submitted for marketing approval of daily wear, single-use colored vision corrective contact lens, which is intended to be used for visual correction. The lens is composed of silicone hydrogel (kalifilcon A) with a moisture content of 55% and an oxygen permeability (Dk) -11 2 of 107 x 10 (cm /sec)·(mLO /[mL x mmHg]). 2 |
| Apr 23, 2021 | TREO Abdominal Stent Graft SystemAortic stent graft | Terumo Corporation | New device | May 4, 2020 | 12 mo later | 263 days | An aortic stent graft indicated for the intravascular treatment of infrarenal abdominal aortic aneurysm that satisfies the specific anatomical conditions. The results of a single-arm clinical study conducted in the US were submitted to evaluate the efficacy and safety of the product. |
| Apr 21, 2021 | FreeStyle Libre 2Glucose monitor system | Abbott Japan LLC | New device | Jun 12, 2020 | 10 mo later | 246 days | The application was submitted for marketing approval of a glucose monitor system that continuously measures glucose levels in the interstitial fluid. The monitored fluctuation patterns of the glucose level are displayed on the screen. |
| Mar 29, 2021 | ReBOSSIS-JAbsorbable bone regeneration material | ORTHOREBIRTH Co., Ltd. | New device | Not listed | — | 208 days | An absorbable bone regeneration material used to fill bony defects caused by trauma, autogenous bone harvesting or treatment of diseases, and to support autogenous bone graft (allograft). The product is a cotton-shaped material consisting of fine fiber combined with β-tricalcium phosphate and a lactic acid-glycolic acid copolymer. The results of a multicenter, open-label study conducted in Japan were submitted to demonstrate the meeting of standard for achieving bone replacement capability based on results of clinical study conducted by another company for its approved product, and to confirm the state of developing no unacceptable adverse event peculiar to this product. |
| Mar 29, 2021 | Biofloat Ventricular Assist Device Set HCSingle-use extracorporeal assistant artificial cardiac pump | Nipro Corporation | New device | Not listed | — | 292 days | A single-use extracorporeal assistant artificial cardiac pump used to maintain normal systemic circulation including the heart itself and improve cardiac insufficiency in patients with severe heart failure exceeding the limit that can be treated with conventional medication or existing assisted circulation (such as intraaortic balloon pumping or venoarterial bypass) due to severe heart failure or cardiogenic shock. This product is concomitantly used with a dedicated driving device “Biofloat Console” (Approval No. 22800BZX00322000). The product adopts an approved device “Biofloat Centrifugal Pump” (Approval No. 22800BZX00321000) as a blood pump. The product was developed to increase auxiliary flow and reduce the risk of hemolysis and thrombus compared to the similar approved device with a pulsating type pump, “Nipro Heparin-Coated Ventricular Assist Device Set” (Approval No. 21700BZZ00011000). As clinical evaluation data, the results of a Japanese clinical study were submitted to evaluate the clinical efficacy and safety of the product for the use in maximum designed duration. |
| Mar 18, 2021 | Reprocessed Trocar E2 (HOGY)Reprocessed single-use trocar sleeve | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 170 days | Reprocessed single-use medical device originating from “Endopath Trocar System” (Certification No. 21900BZX00882000), which is a set of a trocar and a sleeve used to provide a working channel by puncturing it into the abdominal or thoracic cavity. The difference from the company’s approved device “Reprocessed Trocar E (HOGY)” (Approval No. 30200BZX00393000) is that this product originates from the original medical device made with different components. |
| Mar 15, 2021 | 1-Day Acuvue Theravision KSingle-use colored drug-containing contact lenses for correcting visual acuity | Johnson & Johnson K.K. | New device | Not listed | — | 474 days | The application was submitted for marketing approval of single-use colored drug-containing contact lenses used for vision correction, and alleviation of ocular allergic symptoms when wearing contact lenses in patients with allergic conjunctivitis. |
| Feb 9, 2021 | iLux SystemEyelid thermal pulsation system | Alcon Japan Ltd. | New device | Dec 26, 2017 | 37 mo later | 266 days | The application was submitted for marketing approval of an eyelid thermal pulsation system used for providing localized heat and pressures to the eyelids in patients with meibomian gland dysfunction. |
| Feb 8, 2021 | Ranger Drug-Coated Balloon CatheterBalloon-dilating catheter for angioplasty | Boston Scientific Japan K. K. | New device | Oct 30, 2020 | 3 mo later | 497 days | This application was submitted for marketing approval of a paclitaxel-coated balloon-dilating catheter for angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral or proximal popliteal arteries. |
| Feb 5, 2021 | ULTRASCORE Scoring PTA Balloon Catheter 035 OTWBalloon-dilating catheter for angioplasty | Medicon, Inc. | New device | Jun 14, 2017 | 44 mo later | 245 days | The application was submitted for marketing approval of a balloon-dilating catheter for angioplasty used for expanding lesions that are resistant to expansion by a normal balloon catheter in the renal artery, artery of lower extremity, or shunt in the percutaneous transluminal angioplasty (PTA) or for post-expansion at the time of stent placement in these blood vessels. |
| Jan 26, 2021 | Tecnis Symfony Plus VB SimplicityPosterior chamber lenses with an injector | AMO Japan K.K. | New device | Not listed | — | 244 days | The application was submitted for marketing approval of a posterior chamber lens with an injector in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct far, intermediate and near vision of an aphakic eye. |
| Jan 21, 2021 | Surpass Streamline Flow Diverter SystemProsthetic material for embolization in vessels of the central circulation system | Stryker Japan K.K. | New device | Jul 13, 2018 | 30 mo later | 269 days | A flow diverter system intended to be used for endovascular therapy for intracranial aneurysms that are difficult to treat surgically or by coil embolization with a maximum diameter of 10 mm or greater and wide-necked (neck part of 4 mm or greater or dome-to-neck ratio of less than 2) located from the petrous segment to the supraclinoid segment of the internal carotid artery (except for the acute ruptured aneurysms). The results of foreign and Japanese clinical studies to evaluate the efficacy and safety of the product were submitted. |
| Jan 14, 2021 | SHILLA Growth Guidance SystemSpinal internal fixation system | Medtronic Sofamor Danek, Co., Ltd. | New device | Jul 2014 | 78 mo later | 266 days | A spinal internal fixation system used generally in patients aged less than 10 years, with potentially life-threatening, severe, progressive, early-onset scoliosis. The product is used in patients for whom surgical correction and maintaining of correction are necessary, who are with a Cobb angle of 50 degrees or greater, and whose spinal curvature covers at least 6 segments of the spine from the upper end vertebra to the lower end vertebra. The results of a Japanese multicenter study in patients with early-onset scoliosis were submitted to evaluate the level of correction of the Cobb angle at 24 months after surgery for efficacy, and the incidence rate of adverse events and device failures for safety. |
| Jan 8, 2021 | Prosthesis for Microvascular Decompression of Cranial NerveSurgical mesh | Kono Seisakusho Co.,Ltd. | New device | Not listed | — | 262 days | A surgical mesh consisting of polytetrafluoroethylene (PTFE) resin used to keep blood vessels away from nerves during microvascular decompression for trigeminal neuralgia, hemifacial spasm or glossopharyngeal neuralgia. The clinical evaluation report was submitted to evaluate the efficacy and safety of microvascular decompression of cranial nerve. |
| Dec 25, 2020 | Cellex ECP SystemExtracorporeal photopheresis system | Mallinckrodt Pharmaceuticals Ireland Limited | New device | Apr 8, 1987 | 405 mo later | 224 days | The product is a system used for extracorporeal photopheresis therapy for steroid-resistant or intolerant chronic graft versus host disease. The system consists of a main unit, kit, methoxsalen solution, and a UVA lamp. The results of a Japanese clinical study were submitted to evaluate the efficacy and safety of the product. |
| Dec 24, 2020 | VBS Vertecem V+ Bone Cement KitOrthopedic bone cement | Johnson & Johnson K.K. | New device | Not listed | — | 267 days | An orthopedic bone cement intended to be used to stabilize the fractured vertebral body and thereby relieves the pain of patients in acute phase of painful compression fracture of spine due to primary osteoporosis in the one vertebral body from the fifth thoracic vertebrae to the fifth lumbar vertebrate. The product is used for the patients whose lower back pain has not relieved after receiving sufficient conservative treatment. The results of a Japanese multicenter, single-arm study were submitted to evaluate the rate of restoration of vertebral height and pain score for the efficacy and the adverse events for the safety. |
| Dec 24, 2020 | VBS Stent BalloonVertebral body support material | Johnson & Johnson K.K. | New device | Not listed | — | 262 days | A vertebral body support material which creates a cavity in the fractured vertebral body to restore and maintain the vertebral height of fractured vertebral body for patients in acute phase of painful compression fracture of spine due to primary osteoporosis in the one vertebral body from the fifth thoracic vertebrae to the fifth lumbar vertebrate. The product is used for patients whose lower back pain has not relieved after receiving sufficient conservative treatment. The results of a Japanese multicenter, single-arm study were submitted to evaluate the rate of restoration of vertebral height and pain score for the efficacy and the adverse events for the safety. |
| Dec 23, 2020 | HemoSphere Advanced Monitoring PlatformMultiparameter monitor with critical parameters | Edwards Lifesciences Ltd. | New device | Aug 29, 2019 | 16 mo later | 268 days | The application was submitted for marketing approval of a multiparameter monitor with critical parameters intended to measure thermodilution cardiac output, arterial pressure-based cardiac output, blood pressure, venous oxygen saturation, and tissue oxygen saturation, and use to collect and monitor various physiological information. |
| Dec 10, 2020 | Juvederm Vista Volite XCInjectable material to a soft tissue using hyaluronic acid | Allergan Japan K.K. | New device | Not listed | — | 163 days | An injectable material to a soft tissue using hyaluronic acid intended to be used to correct superficial cutaneous depressions such as fine lines and for improvement of skin quality in face and neck in adults by injecting it intradermally. This product consists of hyaluronic acid gel and a syringe. The hyaluronic acid gel contains 0.3 wt% of lidocaine hydrochloride for pain relief during the procedure. The results of a foreign clinical study on injection of the product into the face and neck were submitted as the evaluation of the efficacy and the safety. |
| Dec 10, 2020 | Reprocessed Trocar E (HOGY)Reprocessed single-use trocar sleeve | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 259 days | Reprocessed single-use medical device originating from “Endopath Trocar System” (Certification No. 21900BZX00882000), which is a set of a trocar and a sleeve used to provide a working channel by puncturing it into the abdominal or thoracic cavity. |
| Dec 2, 2020 | WATCHMAN FLX Left Atrial Appendage Closure DeviceEndocardial prosthetic material | Boston Scientific Japan K. K. | New device | Jul 21, 2020 | 4 mo later | 246 days | The device is an endocardial prosthetic material intended to reduce a risk of thromboembolism attributed to the left atrial appendage in patients with non-valvular atrial fibrillation who are at high risk of thromboembolism. This device consists of a delivery system loaded with a closure device and an access system. The device was developed based on the company’s approved product “WATCHMAN Left Atrial Appendage Closure System” (Approval No. 23100BZX00049000). The improvement was made by changing the design for application to a wider range of left atrial appendage size, for easier position adjustment, and for further reduction of the risks of damaging left atrial appendage and of thrombosis. The intended use was also changed so that not only warfarin but also other general anticoagulants can be used in the postoperative period. As clinical evaluation data, the results of US clinical studies were submitted to evaluate the efficacy and safety of this product in patients with non-valvular atrial fibrillation who are at high risk of thromboembolism. |
| Nov 30, 2020 | Leica Virtual Slide System AT2 DXDiagnostic assistant device for pathological whole slide image | Leica Microsystems K.K. | New device | May 20, 2019 | 18 mo later | 264 days | The application was submitted for marketing approval of a diagnostic assistant device for pathological whole slide image, which automatically captures, displays, and stores pathological whole slide images, and is intended to assist pathologists to evaluate and diagnose histopathological images. |
| Nov 24, 2020 | Reprocessed V-pipe (HOGY)Reprocessed single-use natural orifices endoscopic dilator | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 333 days | Reprocessed single-use medical device originating from “Vagi-pipe” (Notification No. 20B1X00005000001), which is an endoscopic dilator used to dilate the vaginal opening during total laparoscopic hysterectomy. |
| Nov 9, 2020 | LIFESTREAM Vascular Stent SystemStent-graft for central circulatory system | Medicon, Inc. | New device | Apr 2017 | 43 mo later | 266 days | The application was submitted for marketing approval of a stent-graft for central circulatory system which consists of a stent graft and a delivery catheter used to treat de novo or restenotic lesions in the iliac arteries. |
| Oct 19, 2020 | XIENCE Skypoint 48 Drug-Eluting StentCoronary stent | Abbott Medical Japan LLC | New device | Not listed | — | 146 days | A stent system consisting of a drug-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo native coronary artery lesions (a lesion length of 44 mm or less) with a reference vessel diameter of 2.25- 4.25 mm, and a delivery catheter used to implant a stent to the site of stenosis. The results of foreign clinical studies were submitted as clinical evaluation data to evaluate the efficacy and safety of the product. |
| Sep 23, 2020 | IN.PACT AV Drug-Coated Balloon (DCB) CatheterBalloon-dilating catheter for angioplasty | Medtronic Japan Co., Ltd. | New device | Not listed | — | 334 days | A balloon-dilating catheter for angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or restenotic lesions in the native arteriovenous dialysis fistulae. The balloon surface of this product is coated with paclitaxel as a drug. The results of a global clinical study including Japan were submitted to evaluate the efficacy and safety of the product. |
| Sep 17, 2020 | Wingman Catheter SystemCatheter for penetrating vascular stenosis | Century Medical, Inc. | New device | Aug 11, 2010 | 121 mo later | 268 days | Catheter for penetrating vascular stenosis used to assist the passage of guide wire and secure the passing parts in chronic total occlusion lesions in the artery of lower extremity which the guide wire is difficult to pass, except the region of iliac arteries. The results of foreign clinical study conducted to evaluate the efficacy and safety of the product were submitted. |
| Sep 4, 2020 | Apple’s ECG AppHome-use ECG program | Apple Inc. | New device | Sep 11, 2018 | 24 mo later | 119 days | A home-use program that creates, records, stores, transfers, and displays single channel ECGs similar to lead-I ECGs. It analyzes the obtained ECG, classifies the wave form as being suggestive of sinus rhythm or atrial fibrillation and notifies the results to the user. A clinical evaluation report summarizing overseas clinical literature was submitted to evaluate the efficacy and safety of the product. |
| Sep 4, 2020 | Apple’s Irregular Rhythm Notification FeatureHome-use cardiac rate monitoring program | Apple Inc. | New device | Sep 11, 2018 | 24 mo later | 116 days | A home-use program that analyzes pulse rate data, detects irregular heartbeats suggestive of atrial fibrillation and notifies the user. A clinical evaluation report summarizing overseas clinical literature was submitted to evaluate the efficacy and safety of the product. |
| Sep 2, 2020 | Clareon TORIC Aspherical Hydrophobic Acryl Intraocular LensPosterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 253 days | The application was submitted for marketing approval of posterior chamber lenses having cylindrical refractivity, which are intended to be used for visual correction of corneal astigmatism. |
| Sep 2, 2020 | BioBlade Laser SystemPDT semiconductor laser | Rakuten Medical Japan K.K. | New device | Not listed | — | 167 days | The application was submitted for marketing approval of a laser system to be used in combination with Akalux IV Infusion 250 mg (non- proprietary name: cetuximab sarotalocan sodium [genetical recombination]) for the treatment of unresectable, locally advanced or recurrent head and neck cancer. |
| Aug 28, 2020 | Evolut PRO+ SystemTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Sep 19, 2019 | 11 mo later | 246 days | A prosthetic cardiac valve system used for transcatheter valve implantation in the native aortic valve or the surgically placed aortic bioprosthetic valve for patients with severe symptomatic native aortic stenosis caused by the calcification of native aortic valve leaflets or patients with symptomatic valvular disease due to dysfunction (stenosis, insufficiency, or combined) of a surgically placed aortic bioprosthetic valve, and who are unable to undergo surgery. The product consists of a porcine pericardial-derived bioprosthetic valve, and a delivery set, which is composed of delivery catheter and loading system. The 23-mm, 26-mm, and 29-mm bioprosthetic valves are identical to those are approved as the components of "CoreValve Evolut PRO" (Approval No.: 23000BZX00196000). As for 34-mm bioprosthetic valve, it has an outer skirt attached to the inflow part of the 34-mm bioprosthetic valve which is approved as the components of "CoreValve Evolut R" (Approval No.: 22800BZX00414000). The profile of delivery catheter is smaller compared with that of CoreValve Evolut PRO. The results of some clinical studies on the previously approved products conducted in the US were submitted to evaluate the efficacy and safety of Evolut PRO+ System. |
| Aug 21, 2020 | CureApp SC Digital Therapeutic and CO Checker for Nicotine Dependence (CureApp, Inc.) SpaceOAR System (Boston Scientific Corporation) FoundationOne Liquid CDx Cancer Genomic ProfileSmoking cessation treatment support system Medical products 4 Absorbable tissue spacer for radiotherapy Program 1 Software for gene variants analysis (for comprehensive genomic profiling for cancer) | Chugai Pharmaceutical Co., Ltd. | New device | Not listed | — | 259 days | This application was submitted for marketing approval of a smoking cessation treatment support system, consisting of a digital therapeutic and an exhaled CO meter to support the smoking cessation treatment for patients with nicotine dependence, to be used as an adjunct to the standard smoking cessation treatment program. A synthetic absorbable material intended to be injected and provide space between the prostate and anterior rectal wall, in order to reduce radiation exposure to the rectum during radiation therapy for prostate cancer. The application was submitted to add other types of powder vial and injection needle. (A “partial change” application submitted during the post-market performance review period) This application was submitted for marketing approval of an analysis program to acquire comprehensive genomic profiling pertaining to 324 cancer-related genes in circulating tumor DNA in the whole blood obtained from patients with solid tumors which contributes to formulating a therapeutic policy and determining the eligibility of drugs. This product also falls under the category of a term name, “Software for analysis of somatic variants (for eligibility identification of antineoplastic agents).” |
| Aug 20, 2020 | Sientra Breast ImplantGel-filled mammary prosthesis | Medical U&A, Inc. | New device | Mar 9, 2012 | 101 mo later | 181 days | A gel-filled artificial breast made of a silicone gel used for breast reconstruction or augmentation in adult women to restore or form the shape of a breast. This product contains a breast implant (round smooth, round textured, and anatomical textured) and a sizer as components. A clinical evaluation report consisting of data related to foreign clinical studies and clinical literatures was submitted to evaluate the incidence of adverse events as the efficacy and safety of the artificial breast. |
| Aug 20, 2020 | ECMO System HLS SET Advanced- LTHeparin-coated percutaneous cardiopulmonary support system | Getinge Group Japan K.K. | New device | Not listed | — | 265 days | This device is a heparin coated extracorporeal circulation system used for cardiopulmonary support. This device consists of a centrifugal pump with an oxygenator, a blood parameter measuring cell, a patient circuit, a gas line filter, a priming set, and a cannulae, and is used with a dedicated driving device, "CARDIOHELP Console" (Approval No.: 22500BZX00277000). This device is a combination of the approved product, "ECMO System HLS Set Advanced" (Approval No.: 22800BZX00092000) and "HLS Cannulae" (Approval No.: 22600BZX00042000), and developed as an ECMO for mid to long-term use by extending the maximum designed duration of use from conventional 6 hours to 14 days. The results of Japanese clinical study were submitted as clinical evaluation data to evaluate clinical efficacy and safety of the product for the use in maximum designed duration. |
| Aug 20, 2020 | Reprocessed Flowtron ACS900 (HOGY)Reprocessed cuff for pneumatically- powered massager | HOGY MEDICAL CO., LTD. | New device | Not listed | — | 511 days | Reprocessed single-use medical device originating from the component of "Flowtron ACS900 (Certification No.: 228ADBZX00013000), which is a pneumatically-powered massager to prevent venous thrombosis by compressing the patient’s leg with pneumatic pressure to promote venous blood circulation. |
| Aug 19, 2020 | Ultrasound Bone Densitometer EchoS SystemUltrasound bone densitometer | Toyo Medic Co., Ltd. | New device | Oct 19, 2018 | 22 mo later | 189 days | An ultrasound bone densitometer to analyze the estimated bone density by measuring the ultrasound pulse reflected from the bone to diagnose the bone nature. This product consists of a main body of EchoS, a transducer, and a personal computer installed with the dedicated software and is not used for definitive diagnosis. A clinical evaluation report consisting of foreign clinical literatures was submitted to confirm the correlation of the estimated bone density analyzed by this product and the bone density measured by a dual-energy x-ray absorptiometry. |
| Aug 4, 2020 | Juvederm Vista Volux XCInjectable material to a soft tissue using hyaluronic acid | Allergan Japan K. K. | New device | Not listed | — | 223 days | An injectable material to a soft tissue using hyaluronic acid injected subcutaneously or into supraperiosteal space to correct volume loss and increase the volume in adult faces. This product consists of hyaluronic acid gel and a syringe. The hyaluronic acid gel contains lidocaine hydrochloride 0.3 wt% for pain relief during the procedure. The results of a foreign clinical study on injection of the product in the chin and jaw were submitted as an evaluation of the efficacy and safety. |
| Aug 3, 2020 | RheocarnaAdsorption hemoperfusion column | Kaneka Corporation | New device | Not listed | — | 263 days | An adsorption hemoperfusion column filled with dextran sulfate and L-tryptophan immobilized cellulose beads used for improving ulcers in arteriosclerosis obliterans for which revascularization is not indicated. The results of Japanese clinical study that evaluated the efficacy and safety of the product were submitted. |
| Jul 17, 2020 | Clareon TORIC Intraocular Lens AutonoMe Auto-pre-loaded Delivery SystemPosterior chamber lenses with an injector | Alcon Japan Ltd. | New device | Not listed | — | 260 days | The application was submitted for marketing approval of posterior chamber lenses with an injector having cylindrical refractivity, which are intended to be used for visual correction of corneal astigmatism. |
| Jul 16, 2020 | PuraStatAbsorbable topical hemostatic material | 3-D Matrix, Ltd. | New device | Not listed | — | 267 days | The product is an absorbable topical hemostatic material in a pre-filled syringe, which is filled with clear synthetic peptide solution, and used for reducing the number of ablation with hemostatic forceps to stop oozing in gastrointestinal endoscopy. In a Japanese clinical study using the frequency in use of hemostatic forceps in gastrointestinal endoscopy as the primary endpoint, it was evaluated that the frequency of use of hemostatic forceps was significantly lower when using this product compared with the conventional hemostatic method. |
| Jul 3, 2020 | Traumacem V+ Bone Cement KitOrthopedic bone cement | Johnson & Johnson K.K. | New device | Sep 28, 2017 | 33 mo later | 259 days | Orthopedic bone cement used for augmentation of the head element of intramedullary femoral nail in patients with poor bone quality. This product consists of polymethylmethacrylate-based polymer powder and methylmethacrylate-based monomer liquid, and is used with the company’s intramedullary femoral nail, "TFN-Advanced Proximal Femoral Nail System" (Approval No.: 22700BZX00142000). A clinical evaluation report summarizing the foreign clinical literatures was submitted to evaluate the safety and efficacy of this product used with the intramedullary femoral nail. |
| Jun 29, 2020 | COVID-19 Pneumonia Image Analysis Program Ali-M3Software for diagnostic X-ray imaging system workstation | MIC Medical Corp. | New device | Not listed | — | 27 days | The application was submitted for marketing approval of a computer detection support software which processes the image information of the lungs obtained from the X-ray computed tomography system, and is used to present reference information on the possibility of containing characteristic findings of COVID-19 pneumonia in the CT image when performing the image diagnosis of pneumonia. |
| Jun 29, 2020 | Coroflex ISAR Neo Coronary StentCoronary stent | Nipro Corporation | New device | Not listed | — | 411 days | A stent system consisting of a sirolimus-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo native coronary artery lesion (a lesion length of 32 mm or less) with a reference vessel diameter of 2.25-4.25 mm, and a delivery catheter used to implant a stent to the site of stenosis. Probucol is used for the product instead of non-biodegradable polymers, as a base to retain the drug. The results of Japanese clinical studies were submitted as clinical evaluation data. |
| Jun 26, 2020 | Automated Hematology Analyzer XN-31Malaria diagnostic device | SYSMEX CORPORATION | New device | Not listed | — | 268 days | Automated Hematology Analyzer XN-31 is a medical device that assists the diagnosis of malaria by counting DNA-containing erythrocytes including malaria parasites in the whole blood leveraging flow cytometry. To demonstrate the evaluation of malaria diagnosis made by Automated Hematology Analyzer XN-31, the study result, which agrees with that obtained by performing microscopy using peripheral blood smears was submitted as the clinical study. |
| Jun 9, 2020 | Vertecem V+ Bone Cement KitOrthopedic bone cement | Johnson & Johnson K.K. | New device | Not listed | — | 253 days | A bone cement for orthopedic surgery used by filling into the vertebral body through a spinal screw with fenestrations in order to fix and stabilize the screw when performing posterior spinal fusion for the spine with lowered bone strength due to osteoporosis, osteopenia, or malignant spinal tumor. The product is used with the company’s “Expedium Verse Fenestrated Screw System (Approval No.: 30200BZX00193000)”. A clinical evaluation report summarizing the foreign clinical literatures, etc. was submitted to evaluate the efficacy and safety of the concomitant use of this product and spinal screw. |
| Jun 9, 2020 | Expedium Verse Fenestrated Screw SystemSpinal internal fixation system | Johnson & Johnson K.K. | New device | Dec 20, 2016 | 42 mo later | 253 days | A spinal internal fixation system used for temporary fixation, support or alignment correction of the spine in patients with spinal diseases such as degenerative disease, trauma, and tumor in the thoracic vertebra, lumbar vertebra, and sacral vertebra. The fenestrations are provided on the screw shaft portion so that bone cement can be injected into the vertebral body. For the spine with lowered bone strength due to osteoporosis, osteopenia, or malignant spinal tumor and thereby may lose the fixability of the screw in the bone, the product is used with the company’s bone cement “Vertecem V+ Bone Cement Kit (Approval No.: 30200BZX00192000)”. A clinical evaluation report summarizing the foreign clinical literatures, etc. was submitted to evaluate the efficacy and safety of the concomitant use of this product and bone cement. |
| May 29, 2020 | Eustachian Tube PlugProsthetic material for eustachian tube | Fuji Systems Corporation | New device | Not listed | — | 346 days | The application was submitted for marketing approval of a prosthetic material for the eustachian tube used to narrow the lumen by placing it into an excessively open eustachian tube to improve the symptoms of patients with refractory patulous eustachian tube who do not respond to conservative treatment. The results of Japanese clinical studies were submitted as clinical evaluation data. |
| Apr 28, 2020 | Tecnis Synergy TVB SimplicityPosterior chamber lenses with an injector | AMO Japan K.K. | New device | Not listed | — | 123 days | The device is a posterior chamber lens with an injector in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision of an aphakic eye with corneal astigmatism. The results of foreign clinical studies were submitted as clinical evaluation data. |
| Apr 16, 2020 | Clariti 1 DaySingle-use colored contact lenses for correcting visual acuity | CooperVision Japan Inc. | New device | Dec 11, 2018 | 16 mo later | 170 days | The application was submitted for marketing approval of daily wear, single-use, colored contact lenses for correction of visual acuity, which are intended to be used for visual correction. The lens is composed of silicone hydrogel (Somofilcon A) with a moisture content of 56% and an oxygen permeability (Dk) of 60. |
| Mar 27, 2020 | MED-EL Bonebridge Bone Conduction ImplantBone-anchored hearing aid | MED-EL Elektro-Medizinische Ger äte GmbH | New device | Jul 20, 2018 | 20 mo later | 245 days | A bone-anchored hearing aid used to improve the ability to hear environmental sounds and speech sounds in bilateral hearing-impaired patients who are not expected to achieve improvement with existing treatment and have normal bone conduction thresholds or mild impairment at least in one ear. The results of foreign clinical studies were submitted as clinical evaluation data. |
| Mar 11, 2020 | Inicell implantDental implant body | Morita Corporation | New device | Not listed | — | 251 days | The application was submitted for marketing approval of a dental implant body used as an artificial dental root which is surgically placed into the jawbone. As a method capable of early loading, a surface of the device is cleaned with sodium hydroxide aqueous solution packed together with the device immediately before implant placement. |
| Mar 6, 2020 | Scalp Cooling Device CellGuardInstrument and device for cooling therapy | Hair Clinic Reve21. Co. Ltd. | New device | Not listed | — | 266 days | An instrument and device for cooling therapy that cools the scalp to prevent drug-induced alopecia in patients with solid cancer. The product is composed of a cooling unit, cooling water, a silicon cap, an inner cap, and an outer cap. The results of Japanese clinical study conducted to evaluate the effectiveness of preventing alopecia and safety of this product in breast cancer patients were submitted as evaluation data. A clinical evaluation report summarizing the literature review of similar foreign medical devices was also submitted. |
| Mar 5, 2020 | ImmunopurePurifier for blood cell removal | Nikkiso Co., Ltd. | New device | Not listed | — | 157 days | A purifier for blood cell removal used for leucocyte-removing therapy intended to induce remission in patients with ulcerative colitis in the active phase, especially in patients with refractory moderate ulcerative colitis. A clinical evaluation report evaluating the efficacy and safety of the product as equivalent to similar medical devices was submitted. |
| Mar 5, 2020 | PK Papyrus Covered Coronary Stent SystemCoronary arterial stent graft | Biotronik Japan, Inc. | New device | Sep 14, 2018 | 18 mo later | 212 days | A coronary arterial stent graft used for the life- saving urgent intervention for perforations in coronary artery with a reference vessel diameter ranging from 2.5 mm to 5.0 mm or coronary bypass graft. The product achieved excellent flexibility, a low crossing profile, and a small stent diameter for the treatment of small vessels, and was designed based on the concept of improving the success rate for the treatment of coronary perforations and reducing the risk involving suitability of guiding catheters. As clinical evaluation data, the clinical evaluation report summarizing clinical literatures on the evaluation of the efficacy and safety of the product was submitted. |
| Mar 2, 2020 | Attain Stability LeadImplantable defibrillator/pacema ker lead | Medtronic Japan Co., Ltd. | New device | Not listed | — | 311 days | The device is a coronary venous lead of implantable biventricular pacing pulse generator for cardiac resynchronization therapy. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. The product was developed based on the company’s approved product. The improvement of the device is its side helix mechanism which enables active fixation to the coronary vein wall. As clinical evaluation data, the results of foreign clinical studies were submitted to evaluate the efficacy and safety of the helix for fixation to the vessel wall. |
| Feb 20, 2020 | React CatheterEmboli-removal catheter in the central circulatory system | Medtronic Japan Co., Ltd. | New device | Jul 4, 2018 | 20 mo later | 211 days | An emboli-removal catheter in the central circulatory system used for revascularization for patients with acute ischemic stroke (in principle, within 8 hours of the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) therapy or who failed in revascularization with the t-PA therapy. A clinical evaluation report summarizing the contents of Japanese and foreign clinical literatures, etc. was submitted to evaluate the efficacy and safety of the procedure for aspirating and retrieving thrombus only with a catheter (a Direct Aspiration first Pass Technique [ADAPT]). |
| Feb 20, 2020 | Tecnis Synergy VB SimplicityPosterior chamber lenses with an injector | AMO Japan K.K. | New device | Not listed | — | 143 days | The device is a posterior chamber lens with an injector in which a multifocal posterior chamber lens is preloaded into a single-use intraocular lens injector, and the lens is intended to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision of an aphakic eye. The results of foreign clinical studies were submitted as clinical evaluation data. |
| Feb 19, 2020 | Dexcom G6 CGM SystemGlucose monitoring system | Dexcom, Inc. | New device | Mar 27, 2018 | 23 mo later | 266 days | The application was submitted for marketing approval of a continuous glucose monitoring system that continuously measures and records glucose concentration in the interstitial fluid in persons with diabetes and displays the trends and the patterns of glucose fluctuation. |
| Feb 19, 2020 | Embozene MicrospheresProsthetic material for embolization in vessels of the central circulation system | Boston Scientific Japan K. K. | New device | Dec 15, 2008 | 134 mo later | 267 days | A non-absorbable prosthetic material for embolization in vessels of the central circulation system intended to be used for arterial embolization in patients with hypervascular tumors or arteriovenous malformation. The product is characterized by a higher uniformity and a wider range of particle sizes (including smaller sizes [40 μm, 75 μm] and a larger size [1300 μm]) compared to the original product, “Embosphere” (Approval No. 22500BZX00269000). As clinical evaluation data, the clinical evaluation report consisting of data from publications on the equivalence of the similar medical devices was submitted to confirm the efficacy and safety of the product. |
| Feb 13, 2020 | QDOT Micro CatheterCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Not listed | — | 254 days | An electrode catheter to be used for conducting cardiac electrophysiologic mapping, and cardiac ablation with high-frequency current for the treatment of patients with drug refractory symptomatic paroxysmal or persistent atrial fibrillation, atrial flutter, and patients with ventricular tachycardia who cannot be successfully treated by other therapies. The device was developed based on “Thermocool Smarttouch SF” (Approval No. 22800BZX00244000). The major changes were the location and the number of temperature sensors, additional micro electrodes, and two ablation modes; QMODE (temperature control mode for this device only) and QMODE+ (mode for the delivery of high power, short duration ablation). As clinical evaluation data, the results of foreign clinical studies were submitted to evaluate the efficacy and safety of the QMODE+ mode. |
| Feb 6, 2020 | RM Pressfit vitamys cupArtificial hip joint, acetabular component | Mathys Ltd. | New device | Not listed | — | 230 days | A hip arthroplasty acetabular component used for replacement and repair of the acetabulum at the pelvic side in order to substitute for the function of the hip joint. This product was improved by developing as a monoblock cup which is directly fixed in order to avoid friction caused by the difference of hardness between the cup and liner, while the conventional type was a modular cup which is used by combining the cup and liner. The clinical evaluation report consisting of data from foreign post-marketing clinical trials, foreign registry data, and published clinical literatures was submitted to confirm that product-specific adverse events have not been found. |
| Jan 10, 2020 | LightSheer Duet Diode Laser SystemDiode laser | Lumenis Japan Co., Ltd. | New device | Apr 7, 2006 | 165 mo later | 197 days | A diode laser is intended to achieve stable long- term hair reduction by selective photothermolysis. In addition to ET handpiece mounted a sapphire tip to reduce complications by cooling the skin, the improvement was made by developing HS handpiece to perform laser irradiation by skin suction. The clinical evaluation report consisting of data from foreign clinical studies and published clinical literatures was submitted to confirm that long-term hair reduction and expected adverse events could be acceptable as a cosmetic medical device. |
| Dec 26, 2019 | Woven EndoBridge DeviceProsthetic material for embolization in vessels of the central circulation system | Terumo Corporation | New device | Dec 31, 2018 | 12 mo later | 302 days | A prosthetic material for embolization in vessels of the central circulation system intended to be used to occlude wide-necked (defined the size as neck ≥4 width mm or dome-to-neck ratio <2) intracranial aneurysms located in the branch of anterior or posterior circulation. The results of foreign clinical studies conducted to evaluate the efficacy and safety of the product were submitted. |
| Dec 26, 2019 | Lotus Edge Valve SystemTranscatheter bovine pericardial valve | Boston Scientific Japan K. K. | New device | Apr 23, 2019 | 8 mo later | 301 days | A self-expandable percutaneous aortic bioprosthetic valve system for a percutaneous aortic valve replacement used in symptomatic patients with severe aortic valve stenosis attributed to calcification and degeneration of the native aortic valve, who are not eligible for surgery and of which this treatment is considered as their best therapeutic option. The bioprosthetic valve has 3 pairs of locking mechanisms and is locked to a specified frame height and diameter after being implanted. As clinical evaluation data, the results of foreign and Japanese clinical studies were submitted. |
| Dec 19, 2019 | BioMimics 3D Stent SystemStent for blood vessel | Medico's Hirata Inc. | New device | Oct 4, 2018 | 14 mo later | 268 days | A vascular stent used for treatment of symptomatic peripheral arterial disease with reference vessel diameter of 4-6 mm and a lesion length up to 140 mm in the native superficial femoral artery and/ or proximal popliteal artery, and for treatment of acute or impending occlusion in the aforementioned sites following the failure of interventional treatment. The product is characterised in that the product has a unique helical shape that enables the kink and fracture to be suppressed with interspersed mechanical strain as the knee/hip is bent, while previously approved stents are straight shapes. The result of a global clinical trial was submitted to confirm the efficacy and safety of the product in patients with symptomatic peripheral arterial disease. |
| Dec 18, 2019 | CASPER Rx Carotid Artery StentCarotid artery stent | Terumo Corporation | New device | Not listed | — | 237 days | A stent system used for extending and maintaining the vascular lumen via a catheter percutaneously inserted and placed in the site of stenosis in the carotid artery (common carotid artery and internal carotid artery). The main difference between the previously approved product and the product is that the previously approved carotid artery stent is indicated only for use in patients with a high risk of carotid endarterectomy (CEA), while the product is indicated for use in patients regardless of CEA risk. As data from results of non-clinical studies related to the product, data on physicochemical characterizations, biological safety and animal study results were submitted. The data related to the results of Japanese clinical studies using the product were also submitted. Patients with carotid stenosis were included in the clinical studies regardless of CEA risk, and the efficacy and safety of the product were evaluated. |
| Dec 12, 2019 | Precision 1Single-use colored contact lenses for correcting visual acuity | Alcon Japan Ltd. | New device | Dec 11, 2018 | 12 mo later | 259 days | The device is a single-use, colored contact lens for correcting visual acuity consisting of silicone hydrogel with a water content of 51% (Verofilcon A). |
| Dec 10, 2019 | CathWorks FFRangioCirculatory dynamics analysis instrument | CathWorks Ltd. | New device | Dec 19, 2018 | 12 mo later | 265 days | A diagnosis support device that calculates the FFRangio (Fractional Flow Reserve) by numerical analysis of the reconstructed three dimensional coronary artery model based on the images of coronary angiography in patients suspected of having coronary artery diseases. The device is installed and used in the catheterization laboratory. It is characterized in that the results can be calculated and displayed on the spot, without transferring data of contrast image, etc. to outside the hospital. As clinical evaluation data, the results of foreign clinical studies conducted to evaluate the efficacy and safety of the product were submitted. |
| Nov 18, 2019 | LENTIS Comfort ToricMultifocal posterior chamber lens | Santen Pharmaceutical Co., Ltd | New device | Not listed | — | 172 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct far and intermediate vision of an aphakic eye with corneal astigmatism. The improvement was made to the product in that cylindrical refractivity was added in the posterior optical zone of the company’s approved product “Lentis Comfort” (Approval No.: 23000BZX00243000). |
| Nov 5, 2019 | LipiFlow Thermal Pulsation SystemEyelid thermal pulsation system | AMO Japan K.K. | New device | Jun 28, 2011 | 100 mo later | 251 days | The application was submitted for marketing approval of a device designed for providing localized heat and pressures to the eyelids in patients with meibomian gland dysfunction (MGD). |
| Oct 31, 2019 | iStent inject Trabecular Micro- Bypass System (Glaukos Corporation) RETISSA Medical ApprovalHeparin-using intraocular drain Instrument & apparatus 71 Laser retinal scanning type eyewear | QD Laser, Inc. | New device | Jun 12, 2018 | 17 mo later | 335 days | A stent and the injector used simultaneously in cataract surgery for lowering intraocular pressure in patients with mild to moderate open-angle glaucoma. This device is the successor product of “iStent Trabecular Micro-Bypass Stent System” (Approval No. 22800BZI00013000). The improvements were made to the product in that two stents were loaded within the injector and the operability was refined. Laser projector type eyewear intended to be used for visual correction in patients whose vision is affected by irregular astigmatism (whose vision cannot be corrected sufficiently by conventional glasses or contact lenses). The results of Japanese clinical studies were submitted as clinical evaluation data. |
| Oct 31, 2019 | INVOS 5100C SystemCerebral oximeter | Covidien Japan, Inc. | New device | May 14, 2008 | 138 mo later | 230 days | A medical device measuring regional hemoglobin oxygen saturation (rSO ) of blood in the brain or in 2 other tissue beneath the sensor and using as an adjunct trend monitor of them. |
| Oct 28, 2019 | Palacos R+G Bone CementOrthopedic bone cement | AquaMed Japan, Inc. | New device | May 2004 | 185 mo later | 269 days | Orthopedic bone cement intended for use in fixation of joint prostheses (prosthetic hip, knee, shoulder, elbow, hand, foot, head prosthesis, etc.) to living bone at the second stage in two-stage reimplantation accompanied by post-surgery infection due to prosthetic joint replacement. It consists of powdered and liquid components and a mixing device. The improvement was made to the product in that an antibiotic (gentamicin) was contained into the company’s approved powdered polymer. A clinical evaluation report summarizing foreign clinical papers and information on foreign post-marketing malfunctions was submitted to compare with the product without gentamicin and evaluate that the clinical results of prosthetic joint replacement using the product are equivalent. |
| Oct 24, 2019 | PulseRiderProsthetic material for embolization in vessels of the central circulation system | Johnson & Johnson K.K. | New device | Jun 19, 2017 | 28 mo later | 267 days | A device intended for the treatment of wide- necked cerebral aneurysms at a vessel bifurcation that are difficult to treat with surgery or coil embolization with embolic coils alone. It consists of a device for cerebral aneurysms at a vessel bifurcation to be placed for preventing a coil mass from protruding into and/or dropout into the parent artery during the coil embolization treatment and a detachment system. The results of foreign clinical studies conducted to evaluate the performance and safety of the product were submitted. |
| Sep 30, 2019 | Fractional RF Elos PlusTherapeutic electrosurgical device | Syneron Candela K. K. | New device | Not listed | — | 166 days | A therapeutic electrosurgical device intended to be used ablation of soft tissue for fractional skin resurfacing for cosmetic improvement. The intended use of this product is equivalent to that of the company's approved product, “CO2RE Carbon Dioxide Laser with Fractional Mode” (Approval No. 22900BZX00428000). This product is improved by the use of radiofrequency, while the company's approved product uses the principle of CO2 laser. A clinical evaluation report consisting of published clinical literatures of this product and results from a foreign clinical study of the previous generation product was submitted to confirm that performance for skin resurfacing and adverse events are acceptable for cosmetic uses. |
| Sep 25, 2019 | Valiant Navion Thoracic Stent Graft SystemAortic stent graft | Medtronic Japan Co., Ltd. | New device | Oct 19, 2018 | 11 mo later | 365 days | A stent graft system is used to treat patients with descending thoracic aortic aneurysms or complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who do not respond to medical treatment. The product was designed based on “Valiant Thoracic Stent Graft System” (Approval No. 22400BZX00124000) and for which the graft material and stent design, etc. were changed to have a delivery catheter with a smaller diameter for improved accessibility to lesions. The result of foreign clinical study in aortic aneurysm and clinical evaluation report summarizing the contents of Japanese and foreign clinical literatures, etc. on chronic complicated Stanford type B aortic dissection were submitted to evaluate the efficacy and safety of the product. |
| Sep 18, 2019 | COMBO Plus Coronary StentCoronary stent using murine antibody | OrbusNeich Medical K. K. | New device | Not listed | — | 384 days | A coronary stent system used for treating patients with symptomatic ischemic cardiac disease who have a de novo coronary artery lesion (a lesion length of 28 mm or less) with a reference vessel diameter of 2.5-3.5 mm. A murine-derived anti- CD34 antibody to capture endothelial progenitor cells (ECPs) in circulating blood and sirolimus to inhibit cell proliferation are coated on the stent surface. As clinical evaluation data, the results of global clinical studies including Japan were submitted to evaluate the effectiveness and safety of this product. |
| Sep 10, 2019 | AMPLATZER Piccolo OccluderProsthetic material for embolization in vessels of the central circulation system | Abbott Medical Japan Co., Ltd. | New device | Jan 11, 2019 | 8 mo later | 263 days | A self-expanding duct occluder and delivery system intended to be used for percutaneous closure of an opening of the arterial duct in patients with patent ductus arteriosus (PDA). As clinical evaluation data, the results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product in patients with PDA including low birth weight infants. |
| Aug 20, 2019 | FRED SystemProsthetic material for embolization in vessels of the central circulation system | Terumo Corporation | New device | Not listed | — | 358 days | A flow diverter system intended to be used to occlude intracranial aneurysms (including fusiform aneurysm) that are difficult to treat surgically or by coil embolization with a maximum diameter of 5 mm or greater and wide-necked (neck part of 4 mm or greater or dome-to-neck ratio of less than 2) located from the petrous segment of the internal carotid artery to the proximal regions of the middle cerebral artery and anterior cerebral artery, and in basilar and vertebral arteries, except for the acute phase of aneurysms that are at risk of rupture. As clinical study data, results of foreign clinical studies to evaluate the efficacy and safety of the product and a Japanese clinical study to confirm the compatibility of the device with the medical environment in Japan were submitted. |
| Aug 20, 2019 | Zepto SystemOphthalmic electrosurgical unit | Mynosys Cellular Devices, Inc. | New device | Jun 2, 2017 | 27 mo later | 266 days | The application was submitted for marketing approval of an ophthalmic electrosurgical device that is indicated for use in performing anterior capsulotomy during cataract surgery. |
| Jul 9, 2019 | TMJ Replacement SystemTotal temporomandibular joint prosthesis | Medical U&A, Inc. | New device | Sep 21, 2005 | 166 mo later | 252 days | A total temporomandibular joint prosthesis is used in patients with oral and maxillofacial symptoms that are difficult to cure or alleviate by any treatments other than replacement or reconstruction of the glenoid cavity and mandibular condyle. The improvement in the product was made to enable replacement or reconstruction of the glenoid cavity as well as the mandibular condyle. A clinical evaluation report summarizing foreign clinical studies, post- marketing prospective observational studies, and clinical papers was submitted. |
| Jul 5, 2019 | Resolute Onyx SV Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Nov 16, 2017 | 20 mo later | 695 days | A stent system consisting of a drug-eluting stent used for treating patients with symptomatic ischemic cardiac disease who have a new coronary artery lesion (a lesion length of 27 mm or less) that have a reference vessel diameter of 2.0- 2.25 mm and are considered as vascular dissection or acute or impending coronary occlusion associated with angioplasty, and a delivery catheter to place the stent at the site of stenosis. As clinical evaluation data, the results of global clinical studies including Japan were submitted to evaluate the efficacy and safety of the product. |
| Jun 10, 2019 | EmboTrap Revascularization DeviceEmboli-removal catheter in the central circulatory system | Johnson & Johnson K.K. | New device | May 9, 2018 | 13 mo later | 257 days | A revascularization device in the central circulatory system used for revascularization of patients with acute ischemic stroke (in principle, within 8 hours of symptom onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed in revascularization with intravenous t-PA therapy. The product is characterized by proprietary design of its dual- layered stent. The results of foreign clinical studies which were conducted to verify the efficacy and safety of the product were submitted. |
| May 29, 2019 | BonarcArtificial bone using collagen | TOYOBO CO., LTD. | New device | Not listed | — | 527 days | A bone void filler made of octacalcium phosphate and collagen intended for bone regeneration treatments with filling it into bone defects or gaps in the upper/lower jaw bones and alveolar bones. These treatments include bone regeneration assuming placement of dental implants and bone regeneration for cleft palate and cyst cavities. The results of Japanese clinical studies that evaluated the efficacy and safety of the product were submitted. |
| May 28, 2019 | AMPLATZER PFO OccluderProsthetic material for artificial cardiac membrane | Abbott Medical Japan L.L.C. | New device | Oct 28, 2016 | 31 mo later | 333 days | A percutaneous transcatheter closure device of a patent foramen ovale (PFO) is used to reduce the risk of recurrence of cerebral infarction in patients with a history of cryptogenic cerebral infarction in whom the existence of PFO is determined to be related to the onset of cerebral infarction. Data from foreign clinical studies were submitted as clinical evaluation data. |
| May 23, 2019 | PREVENA Incision Management SystemSingle-use negative pressure wound therapy system | KCI K.K. | New device | Jun 11, 2010 | 107 mo later | 267 days | A single-use negative pressure wound therapy system intended to reduce the risk of surgical site infection (SSI) by maintaining the closure environment for closed surgical incisions in patients at high SSI risk and providing controlled negative pressure to remove effusion. The following improvement was made to the product: Approved devices for negative pressure maintenance/management therapy are indicated for refractory wounds that have not responded or are considered unlikely to respond to conventional treatments, whereas the product is intended to reduce the risk of SSI with the indication of closed surgical incisions. A clinical evaluation report summarizing meta-analyses for comparison between the product and conventional treatments and information on malfunctions and adverse event was submitted to evaluate the efficacy and safety of the product. |
| May 22, 2019 | AXS Catalyst Aspiration CatheterEmboli-removal catheter in the central circulatory system | Stryker Japan K.K. | New device | Mar 18, 2018 | 14 mo later | 147 days | An emboli-removal catheter in the central circulatory system used for revascularization of patients with acute ischemic stroke (in principle, within 8 hours of symptom onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed in revascularization with intravenous t-PA therapy. A clinical evaluation report summarizing the contents of Japanese and foreign clinical literatures, etc. was submitted to evaluate the efficacy and safety of the procedure for aspirating and retrieving thrombus only with a catheter (a Direct Aspiration first Pass Technique). |
| Apr 25, 2019 | VenaSeal Closure SystemProsthetic material for embolization in blood vessels | Covidien Japan, Inc. | New device | Feb 25, 2015 | 50 mo later | 359 days | A prosthetic material for embolization in blood vessels to treat venous reflux by injecting it into primary varicose vein in the lower extremity truncal saphenous vein. This device consists of the adhesive composed mainly of n-butyl-2- cyanoacrylate and the delivery system to inject the adhesive into the vein. The results of foreign controlled clinical studies with high-frequency ablation as conventional treatment, were submitted to evaluate the efficacy and safety of the device. |
| Apr 25, 2019 | SurgifloGelatin-based local absorbable hemostatic material with human thrombin | Johnson & Johnson K.K. | New device | May 16, 2016 | 35 mo later | 268 days | A gelatin-based local absorbable hemostatic material with human thrombin used in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. The results of foreign clinical studies using the previous-generation product were submitted. Based on the results of animal studies, literature reports, etc., it was explained that the changes from the previous-generation product would not greatly affect the efficacy and safety of the product. |
| Apr 16, 2019 | HeartMate 3 Left Ventricular Assist SystemImplantable ventricular assist device | Thoratec Corporation | New device | Aug 23, 2017 | 20 mo later | 370 days | The device is an implantable ventricular assist device system used to improve the blood circulation until heart transplantation. The device is used for patients who are shown continuous decompensation in spite of drug therapy or circulation assist techniques, such as an external ventricular assist system and considered difficult to survive without heart transplant. The blood pump of the product is a downsized centrifugal pump compared to that of the approved product "HeartMate II Left Ventricular Assist System" (Approval No. 22400BZI00017000) so that it is not necessary to create a pump pocket at the time of implantation. The blood is discharged by rotating the rotor inside the pump with magnetic levitation. The results of foreign clinical studies were submitted as clinical evaluation data. |
| Mar 27, 2019 | Paxman Scalp Cooling System OrbisInstrument and device for cooling therapy | Century Medical, Inc. | New device | Not listed | — | 362 days | An electronically controlled cooling device that cools the scalp to prevent hair loss in patients receiving drug therapy for their solid cancer. The product is used in connection with “Paxman Scalp Cooling Cap” (23100BZX00088000). The results of Japanese clinical study for evaluation of the efficacy and safety of this product to prevent chemotherapy induced hair loss in patients with breast cancer were submitted as evaluation data. The results of foreign clinical studies, results of literature search, etc. were also submitted as reference data. |
| Mar 27, 2019 | Paxman Scalp Cooling CapInstrument and device for cooling therapy | Century Medical, Inc. | New device | Jun 7, 2018 | 10 mo later | 362 days | A cooling cap that cools the scalp to prevent hair loss in patients receiving drug therapy for their solid cancer. The product is composed of a silicon cap and a cap cover that protects the cap, and it is used in connection with “Paxman Scalp Cooling System Orbis” (23100BZX00087000). The results of Japanese clinical study for evaluation of the efficacy and safety of this product to prevent chemotherapy induced hair loss in patients with breast cancer were submitted as evaluation data. The results of foreign clinical studies, results of literature search, etc. were also submitted as reference data. |
| Mar 7, 2019 | DuraGen Artificial Dura MaterCollagen-using absorbent artificial dura mater | EPJ Medical Service Co., Ltd. | New device | Jul 1999 | 236 mo later | 629 days | A collagen-using absorbent artificial dura mater used for prosthesis for deficiency part of dura mater. The product is different from the existing artificial dura maters in that the spinal dura mater is included as the indicated site and suture is not necessary for prosthesis. A clinical evaluation report summarizing the contents of foreign clinical studies, literatures, etc. was submitted to evaluate the efficacy and safety of the product. |
| Feb 21, 2019 | Ovation Abdominal Stent Graft SystemAortic stent graft | Endologix, Inc. | New device | Dec 11, 2012 | 74 mo later | 329 days | A stent graft system for the treatment of abdominal aortic aneurysms that obtains adhesion to blood vessels by filling polymer. The product is delivered and placed in a transcatheter manner to abdominal aortic aneurysms and prevents aortic rupture by excluding blood flow into the aortic aneurysms. The result of foreign clinical study was submitted to evaluate the efficacy and safety of the product in patients with abdominal aortic aneurysms. |
| Feb 21, 2019 | WATCHMAN Left Atrial Appendage Closure DeviceEndocardial prosthetic material | Boston Scientific Japan K. K. | New device | Mar 13, 2015 | 47 mo later | 267 days | This device was developed to reduce the risk of ischemic stroke and systemic embolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for thromboembolism. The device consists of a delivery system loaded with a closure device, a sheath for delivering the delivery system to the left atrial appendage, and a dilator. By closing the left atrial appendage with a percutaneously delivered closure device, it is intended to reduce the risk of ischemic stroke and systemic embolism caused by left atrial appendage thrombus. The results of foreign and Japanese clinical studies using the product were submitted to evaluate the efficacy and safety of the product. |
| Feb 20, 2019 | Alcon AcrySof IQ PanOptix Single-PieceMultifocal posterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 216 days | The product is a single-piece multifocal posterior chamber lens to be inserted into an aphakic eye after cataract surgery. The improvement was made to the product in that it has a trifocal diffractive structure, while the company’s approved product, “Alcon AcrySof IQ ReSTOR Single-Piece” (Approval No. 22000BZX00970000) has a bifocal diffractive structure. The results of Japanese clinical studies were submitted to evaluate the clinical efficacy and safety of the product including its multifocal mechanism, in addition to the performance evaluation of its multifocal mechanism. |
| Feb 20, 2019 | Alcon AcrySof IQ PanOptix Toric Single- PieceMultifocal posterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 211 days | The product is a single-piece multifocal posterior chamber lens to be inserted into an aphakic eye after cataract surgery accompanied with corneal astigmatism. The improvement was made to the product in that it has a trifocal diffractive structure the same as that of “Alcon AcrySof IQ PanOptix Single Piece” (Approval No. 23100BZX00042000), while the company’s approved products, “Alcon AcrySof IQ ReSTOR +2.5D Toric Single Piece” (Approval No. 22700BZX00006000) and “Alcon AcrySof IQ ReSTOR Toric Single Piece” (Approval No. 22600BZX00007000) each have a bifocal diffractive structure. Since the evaluation of aberrations of cylindrical axis for the company’s approved products showed that trifocusing on the front of the optical part does not affect the rotation, the efficacy and safety of the product were evaluated based on the results of a Japanese clinical study of “Alcon AcrySof IQ PanOptix Single Piece.” |
| Jan 23, 2019 | Excimer Laser Turbo CatheterLaser angioplasty catheter | Spectranetics Corporation | New device | Apr 27, 2004 | 177 mo later | 362 days | A laser angioplasty catheter used for percutaneous endovascular treatment given to restenotic or reocclusive lesions that occur within a stent placed in the femoropopliteal artery. The product is used with an exclusive laser oscillator, “Excimer Laser Angioplasty Device” (Approval No.21300BZY00528000). The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product compared to a standard balloon-alone treatment. |
| Jan 21, 2019 | Brainsway TMS SystemRepetitive transcranial magnetic stimulator | Century Medical, Inc. | New device | Jan 1, 2013 | 73 mo later | 364 days | A repetitive transcranial magnetic stimulator that provides treatment for adult patients with Major Depressive Disorder (MDD) who have not benefitted from conventional antidepressant medication, by stimulating neurons with the electric current induced in the local area of the cerebral cortex using a pulsed magnetic field. The results of foreign clinical studies using the previous- generation products were submitted to evaluate the efficacy and safety of the product in patients with MDD who have not benefitted from conventional antidepressant medication in comparison with the sham treatment group. |
| Dec 27, 2018 | FoundationOne CDx Cancer Genomic ProfileSoftware for gene variants analysis (for comprehensive genomic profiling for cancer) | Chugai Pharmaceutical Co., Ltd. | New device | Nov 30, 2017 | 13 mo later | 286 days | An analysis program to acquire comprehensive genomic profiling pertaining to 324 cancer-related genes obtained from patients with solid tumors which contributes to formulating a therapeutic policy and determining the eligibility of drugs. The study results on analysis performance, clinical performance as a profiling test, and concordance with approved companion diagnostics were submitted. This product also falls under the category of a term name, “Software for analysis of somatic variants (for eligibility identification of antineoplastic agents).” |
| Dec 26, 2018 | XprESS ENT Dilation SystemEndoscopic dilatation catheter | Entellus Medical, Inc. | New device | Apr 5, 2017 | 21 mo later | 383 days | XprESS is a balloon catheter used for dilation of the cartilaginous portion to the isthmus of the Eustachian tube for treating persistent Eustachian tube stenosis through transnasal approach. The product has a new intended use and indication. The improved feature of the product is that it is used for a different treatment site from that of the existing “endoscopic dilatation catheter” in Japan. The results of foreign clinical studies were submitted to evaluate the clinical efficacy and safety of the product for Eustachian tube dysfunction. |
| Dec 26, 2018 | HOYA Vivinex ToricPosterior chamber lenses with an injector | HOYA Corporation | New device | Not listed | — | 147 days | The product is a one-piece monofocal posterior chamber lens to be inserted into an aphakic eye after cataract surgery accompanied with corneal astigmatism. The improvement was made to the product in that correction function of corneal astigmatism was added to the rear face of the monofocal posterior chamber lens of the company’ s approved product, “HOYA Vivinex iSert” (Approval No. 22400BZX00498000). The results of Japanese clinical studies were submitted to evaluate the clinical efficacy and safety of the product including astigmatic correction function. |
| Dec 25, 2018 | OncoGuide NCC Oncopanel SystemGene variants analysis set (for comprehensive genomic profiling for cancer) | Sysmex Corporation | New device | Not listed | — | 180 days | A template DNA preparation reagent and an analysis program to acquire comprehensive genomic profiling pertaining to 114 cancer-related genes obtained from patients with solid tumors which contributes to formulating a therapeutic policy and determining the eligibility of drugs. The study results on analysis performance and clinical performance as a profiling test were submitted. |
| Dec 20, 2018 | Okamoto Condoms VGHygiene products 2 Contraceptive condom for males | Okamoto Industries, Inc. | New device | Not listed | — | 266 days | A contraceptive condom for males intended to help contraception and prevention of sexually transmitted diseases. The product is composed of a condom itself and dressing agent (anti-adhesion agent, lubricant). The lubricant contains 0.5% of SPL7013. Regarding the safety evaluation for SPL7013, a clinical evaluation report that mainly includes the overseas clinical study data of SPL7013 gel for bacterial vaginosis, which has not been approved in Japan, was submitted. |
| Dec 11, 2018 | NESKEEPAbsorbable tissue spacer for radiation therapy | Alfresa Pharma Corporation | New device | Not listed | — | 355 days | A biologically absorbable spacer to provide a space between a malignant tumor and organs at risk in particle radiotherapy. The spacer is an absorbable non-woven fabric made of polyglycolic acid and is placed by laparotomy as a spacer between malignant tumor and organs at risk. A clinical study was conducted in Japan to verify the necessary space was secured and to confirm the safety of the device for patients who have malignant tumors in abdominal cavity or pelvis that require sufficient space between such tumors and organs for particle therapy and have no other effective therapy than particle therapy, and the report was submitted. |
| Dec 11, 2018 | XTRACExcimer laser | JMEC Co., Ltd. | New device | Mar 5, 2008 | 129 mo later | 257 days | An excimer laser that treats skin diseases subject to medium-wave UV therapy by irradiating laser light with wavelength 308 nm in the UV region which is generated by gas mixture containing xenon and chloride to the affected site through a handpiece. While the existing certified UV treatment device used for the equivalent purpose uses excimer lamp as a light source, but this product uses excimer laser as a light source. This point is the difference between this product and the existing certified products. The clinical evaluation report prepared based on overseas literatures, including the clinical results of this device and the previous generation device in other countries, was submitted to evaluate the efficacy and safety of the product equivalent to those of the existing UV treatment devices. |
| Dec 11, 2018 | Tron FX Thrombectomy DeviceEmboli-removal catheter in the central circulatory system | JIMRO Co., Ltd. | New device | Not listed | — | 256 days | A Central circulatory system embolectomy catheter that is intended for use in removing intracerebral clots to restore blood flow in patients with acute ischemic stroke (generally within 8 hours of symptom onset) in whom IV t-PA therapy is not indicated or fails to achieve reperfusion. The results of Japanese clinical studies that evaluated the efficacy and safety of the product for acute ischemic stroke were submitted. |
| Dec 6, 2018 | Eluvia Drug-Eluting Vascular Stent SystemDrug-eluting femoral artery stent | Boston Scientific Japan K. K. | New device | Sep 18, 2018 | 3 mo later | 190 days | A drug-eluting stent used for the treatment of symptomatic vascular disease with a lesion length up to 190 mm in the native femoropopliteal artery with reference vessel diameter of 4 -6 mm for each limb, and for the treatment of acute or impending occlusion in the aforementioned sites following the failure of interventional treatment. The product is a combination of the company's approved stent system and drug coating. The results of the randomized controlled global clinical study conducted to evaluate the performance of the product with a lesion length up to 140 mm using other company’s approved product, “Zilver PTX Drug-Eluting Peripheral Stent” (Approval No. 22400BZX00013000) as a control and the results of the single-arm global clinical study conducted to evaluate the performance of the product with a lesion length up to 190 mm were submitted. |
| Dec 6, 2018 | Implantable Ventricular Assist Device System HVADImplantable ventricular assist device | Medtronic Japan Co., Ltd. | New device | Nov 20, 2012 | 73 mo later | 462 days | The device is an implantable ventricular assist device system used to improve the blood circulation until heart transplant. The device is used for patients who are qualified to receive heart transplant, shown continuous decompensation in spite of drug therapy or circulation assist techniques, such as an external ventricular assist system and considered difficult to survive without heart transplant. A blood pump of the product is a small-sized centrifugal pump compared to that of similar approved products. An impeller inside the pump rotates by the magnetic levitation mechanism and dynamic pressure mechanism. As clinical evaluation data, the results of foreign and Japanese clinical studies were submitted. |
| Dec 5, 2018 | Cerebral Thrombus Aspiration CatheterEmboli-removal catheter in the central circulatory system | Terumo Corporation | New device | Jun 11, 2018 | 6 mo later | 252 days | An emboli-removal catheter in the central circulatory system used for revascularization of patients with acute ischemic stroke (in principle, within 8 hours of symptom onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed in revascularization with intravenous t-PA therapy. The product is different from the approved product, “Penumbra System” (Approval No. 22300BZX00269000) in that it aspirates and retrieves thrombus only with a catheter without using a separator (A Direct Aspiration first Pass Technique, hereinafter referred to as “ADAPT”), and also it aspirates thrombus manually with a syringe. A clinical evaluation report summarizing the contents of Japanese and foreign clinical literatures, etc. was submitted to evaluate the efficacy and safety of ADAPT. |
| Dec 5, 2018 | Supera StentStent for blood vessel | Century Medical, Inc. | New device | Mar 28, 2014 | 56 mo later | 250 days | A self-expanding vascular stent used for the treatment of symptomatic vascular disease with a lesion length up to 140 mm in the native superficial femoral artery and proximal popliteal artery with reference vessel diameter of 4.0-6.5mm, and for the treatment of acute or impending occlusion in the aforementioned sites following the failure of interventional treatment. The results of foreign clinical studies conducted to evaluate the performance of the product were submitted. |
| Nov 21, 2018 | Liftal KSubmucosal filling material for endoscope | Kaigen Pharma Co., Ltd. | New device | Not listed | — | 265 days | A vial product filled with 20 mL of 0.6% sodium alginate solution. The product largely dissociates a gap between the mucosal layer and the muscle layer by staying the submucosa using its viscoelasticity which is the feature of sodium alginate solution. As a result, it allows to form and maintain the bulge of lesions site (mucosal layer) when resecting or dissecting the mucosal layer. Thus, the product is a submucosal filling material for endoscopy intended to improve the operability of resection or dissection of lesion sites during Endoscopic Submucosal Dissection (EDS) and Endoscopic Mucosal Resection (EMR). The results of Japanese clinical studies conducted to verify the efficacy and safety of the product were submitted. |
| Nov 20, 2018 | PDA Closure Set IIProsthetic material for embolization in vessels of the central circulation system | Abbott Medical Japan Co., Ltd. | New device | Aug 18, 2013 | 63 mo later | 270 days | A self-expanding duct occluder and delivery system intended to be used for percutaneous closure of an opening of the arterial duct in patients with patent ductus arteriosus (PDA). The product was developed to improve the placement of the product into smaller arterial ducts and the compatibility with different forms of arterial ducts based on the approved product, “PDA Closure Set” (Approval No. 22000BZX01768000). The results of foreign clinical studies were submitted to verify the clinical efficacy and safety of the product. |
| Oct 31, 2018 | UroLift SystemImplantable prostate tissue lifting system | NeoTract, Inc. | New device | Nov 30, 2017 | 11 mo later | 201 days | An implantable prostate tissue lifting system indicated for the treatment of dysuria associated with prostatic hyperplasia. The system is composed of an implant to be placed in the prostate and a delivery device which delivers the implant transurethrally to the prostate. By placing the implant in the prostate, the product compresses enlarged prostate tissues and relieves compression on the urethra. The results of foreign clinical studies which were conducted to verify the efficacy and safety of the product in patients with prostatic hyperplasia were submitted. |
| Oct 26, 2018 | Juvederm Vista Volbella XCInjectable material to a soft tissue using hyaluronic acid | Allergan Japan K. K. | New device | May 31, 2016 | 29 mo later | 648 days | An Injectable material to a soft tissue using hyaluronic acid used to correct facial wrinkles by injecting it intradermally (from the middle to deep dermis), to correct facial hollows by injecting it subcutaneously or into the deep part on the periosteum, and to augment the lip by injecting it subcutaneously into the lip mucosa. The improvement was made for the product to optimize the injection into the lip or more shallow part of the facial skin by decreasing the concentration of hyaluronic acid gel of the company’s approved product, “Juvederm Vista Voluma XC” (22800BZX00338000). The results of foreign clinical studies were submitted to evaluate the efficacy and safety of the product by this improvement. |
| Oct 26, 2018 | ABTHERA Dressing KitDressing kit for open abdominal wounds | KCI K.K. | New device | Feb 2003 | 188 mo later | 182 days | A dressing kit for open abdominal wounds intended to facilitate early closure of the peritoneum. The product provides the protection of abdominal contents from external environment, efficient drainage, suppression of inflammation, and alleviation of edema by covering the organs inside the abdomen and applying controlled negative pressure in the case where open abdominal wounds are accompanied by exposure of abdominal organs and also abdominal closure by primary suture is difficult. The product is composed of the tubing set, drape, blue foam, and protective layer. An optional item of the product, ABTHERA Negative Pressure Maintenance Controller, is used to transmit negative pressure. Also, this device may be used in combination with the negative pressure maintenance controller of the approved product, “InfoV.A.C. Therapy System” or “V.A.C.Ulta Therapy System.” |
| Oct 23, 2018 | Avaira vReusable colored contact lenses for correcting visual acuity | CooperVision Japan Inc. | New device | Jul 13, 2016 | 27 mo later | 208 days | Reusable colored contact lenses for daily wear intended for the correction of visual acuity. The lens is made of fanfilcon A, a silicone hydrogel. A novel material was developed to improve oxygen permeability and UV absorption, and the results of foreign clinical studies, etc. conducted to evaluate the efficacy and safety were submitted. |
| Oct 23, 2018 | Rohto 2 Week Clear ViewReusable colored contact lenses for correcting visual acuity | CooperVision Japan Inc. | New device | Not listed | — | 208 days | A product with multiple brand name of "Avaira v." |
| Oct 23, 2018 | Rohto 2 Week Fresh ViewReusable colored contact lenses for correcting visual acuity | CooperVision Japan Inc. | New device | Not listed | — | 208 days | A product with multiple brand name of "Avaira v." |
| Oct 18, 2018 | Adherus Dural SealantAbsorbable tissue reinforcement material | Medical U&A, Inc. | New device | Mar 30, 2015 | 43 mo later | 927 days | A synthetic absorbent material used as an absorbable prosthetic material to close a gap between the dura maters, the sutured site of the dura mater, or a gap between the duraplasty material and the dura mater. The results of a foreign clinical study conducted to verify the non- inferiority of this product to approved products for cerebrospinal fluid (CSF) leaks after surgery, etc. were submitted. |
| Sep 21, 2018 | Bridge Occlusion Balloon CatheterIntravascular catheter for embolization of the central circulation system | Spectranetics Corporation | New device | Feb 5, 2016 | 32 mo later | 267 days | A balloon catheter for temporary use in the superior vena cava for the purpose of emergency hemostasis during lead extraction. Since the existing occlusion balloon catheter has a shorter balloon length that is not long enough to achieve emergency hemostasis during lead extraction, this product was developed as a balloon catheter that can cover the entire superior vena cava. A clinical evaluation report summarizing the foreign literatures on the use of this product or similar products was submitted to evaluate the efficacy and safety of the product. |
| Sep 14, 2018 | Triggerfish SensorMeasuring device for corneal curvature variation | SEED Co., Ltd. | New device | Apr 3, 2016 | 29 mo later | 266 days | A contact lens-type pressure sensor that is mounted on the front part of the eye to monitor changes in the corneal curvature induced by changes in the intraocular pressures and to detect peak patterns of variation in intraocular pressure. The device is used in combination with Triggerfish (Approval No. 23000BZX00273000). The results of a foreign clinical study in patients with primary open-angle glaucoma and healthy adults were submitted to confirm the capability to detect changes in corneal curvature, etc. |
| Sep 14, 2018 | TriggerfishTelemetry measuring device for biological signals | SEED Co., Ltd. | New device | Apr 3, 2016 | 29 mo later | 266 days | A device to monitor changes in the corneal curvature induced by changes in the intraocular pressure, to detect peak patterns of variation in intraocular pressure, and to receive and record data measured by Triggerfish Sensor (Approval No. 23000BZX00272000), etc. The results of a foreign clinical study in patients with primary open- angle glaucoma and healthy adults were submitted to confirm the capability to detect changes in corneal curvature, etc. |
| Sep 10, 2018 | UT Filter ASlow continuous hemofilter | Nipro Corporation | New device | Not listed | — | 167 days | The device is used for slow continuous hemofiltration in patients with acute renal failure or those with chronic renal failure with unstable hemodynamics. The device slowly removes and adjusts unwanted metabolites, water, and electrolytes in the blood. The device was developed as a slow continuous hemofilter by changing the size variation of the approved hemodiafilter product (Brand name: Fineflux, Approval No. 22600BZX00004000). |
| Aug 24, 2018 | Ultimate 1 Day SHSingle-use colored contact lenses for correcting visual acuity | Sincere Co., Ltd. | New device | May 26, 2016 | 27 mo later | 269 days | Daily wear, single-use, colored contact lenses for correction of visual acuity. The lens is composed of silicone hydrogel (Olifilcon B) with a moisture content of 47% and an oxygen permeability (Dk) of 120.0. Due to the novelty of the raw material, a foreign clinical study was conducted to confirm the efficacy and safety of the product as a contact lens for visual correction. |
| Aug 21, 2018 | BioMonitor 2Implantable data recorder for electrocardiogram | Biotronik Japan, Inc. | New device | Apr 11, 2016 | 28 mo later | 174 days | An implantable data recorder for electrocardiogram, subcutaneously implanted to diagnose arrhythmia in patients who presented with symptoms such as syncope and in whom the cause of the symptom could not be identified despite a careful examination, and to detect atrial fibrillation in patients with cryptogenic cerebral infarction. The results of a foreign clinical study were submitted to evaluate the arrhythmia detection function and safety. |
| Aug 20, 2018 | Grafton DBMResorbable bone reconstruction material using human demineralized bone matrix | Medtronic Sofamor Danek, Co., Ltd. | New device | Dec 16, 2005 | 152 mo later | 356 days | A resorbable bone reconstruction material using human demineralized bone matrix to fill bony voids and gaps for the purpose of bone tissue reconstruction. The product consists of human demineralized bone matrix and glycerol. A clinical evaluation report primarily consisting of the results of a foreign post-marketing clinical study, a literature review, and an adverse event report was submitted to evaluate the efficacy and safety of the product as a bone reconstruction material. |
| Aug 17, 2018 | Lentis ComfortMultifocal posterior chamber lens | Santen Pharmaceutical Co., Ltd. | New device | Not listed | — | 268 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct far and intermediate vision of an aphakic eye. The improved points are that the product has a refractive multifocal mechanism with two regions with different curvature radius of the optic zone, a pair of plate supports, and that it uses new raw materials. A Japanese clinical study was conducted to confirm the clinical efficacy and safety of the product including visual function as a multifocal posterior chamber lens. |
| Aug 2, 2018 | Percepta MRI CRT-P SeriesImplantable biventricular pacing pulse generator without defibrillator function | Medtronic Japan Co., Ltd. | New device | May 6, 2017 | 15 mo later | 464 days | The device is an implantable biventricular pacing pulse generator without a defibrillator function. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. The device was developed based on the approved product, "Medtronic Viva CRT-P" (Approval No. 22600BZX00304000). Major improved points are conditionally allowed MRI scans and an additional feature to assess the efficacy of CRT pacing during atrial fibrillation (AF) and to regulate the pacing rates according to the assessment (EffectivCRT during AF feature). The results of a foreign clinical study were submitted to evaluate the efficacy and safety of the EffectivCRT during AF feature. |
| Jul 10, 2018 | Neo Sight One Day AeroSingle-use colored contact lenses for correcting visual acuity | Aire Inc. | New device | Not listed | — | 270 days | Daily wear, single-use, colored contact lenses for correction of visual acuity. The lens is composed of silicone hydrogel with a moisture content of 45% and an oxygen permeability (Dk) of 58.5. Due to the novelty of the raw material, a Japanese clinical study was conducted to confirm the efficacy and safety of the product as a contact lens for visual correction. |
| Jun 29, 2018 | CoreValve Evolut PROTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Mar 20, 2017 | 15 mo later | 301 days | A prosthetic cardiac valve system used for transcatheter valve implantation in the native aortic valve for patients with severe symptomatic native aortic stenosis caused by the calcification of native aortic valve leaflets, and who are unable to undergo surgery. The product consists of a porcine pericardial-derived bioprosthetic valve and a delivery set composed of a delivery catheter system and a loading system. An outer skirt is attached to the inflow part of the bioprosthetic valve of the approved product, “CoreValve Evolut R” (Approval No. 22800BZX00414000) to reduce paravalvular regurgitation. The results of a clinical study conducted in the US to examine the efficacy and safety of the product were submitted. |
| Jun 25, 2018 | InspireHypoglossal nerve stimulator | Inspire Medical Systems, Inc. | New device | Apr 30, 2014 | 50 mo later | 363 days | An implantable device used to stimulate the hypoglossal nerve in synchronization with breathing to improve airway patency in patients with moderate-to-severe obstructive sleep apnea syndrome who are ineligible for, or intolerant to, continuous positive airway pressure (CPAP) therapy. The product consists of a pulse generator, stimulation lead, sensing lead, programmer for physicians, and programmer for patients. The results of a foreign clinical study that was conducted to confirm the efficacy and safety of the product in patients who are ineligible for, or intolerant to, CPAP were submitted. |
| Jun 7, 2018 | CorPath GRX SystemCatheter manipulation equipment for use in the cardiac and central circulatory system | Corindus, Inc. | New device | Oct 27, 2016 | 19 mo later | 359 days | Remote catheter manipulation equipment to be installed in a cardiac catheterization room to manipulate and hold guiding catheters, guidewires, rapid exchange balloon dilatation catheters for coronary angioplasty, and rapid exchange coronary stent catheters that are used for percutaneous coronary intervention (PCI). The product consists of a remote work space, a bed- side unit, and single-use articles. The results of a foreign clinical study using the previous generation model of the product were submitted to evaluate the efficacy and safety of the product in patients who undergo PCI. |
| Jun 5, 2018 | Perceval Bioprosthetic ValveBovine pericardial valve | Sorin Group Italia S.r.l. | New device | Jan 8, 2016 | 29 mo later | 872 days | The device is designed to replace a diseased native aortic valve or a malfunctioning prosthetic aortic valve via open heart surgery. The device primarily consists of a bioprosthetic valve composed of bovine pericardium and a self- expandable metallic stent made of nickel-titanium alloy, a holder handle to position and deploy the bioprosthetic valve at the aortic valve position, and a dilating balloon to expand the bioprosthetic valve after implantation. Unlike conventional bioprosthetic valves for aortic valve replacement (AVR), this device does not require suturing of the bioprosthetic valve with suturing threads because all sutures are eventually removed. The stent’s radial force allows stable anchoring of the bioprosthetic valve as the stent of the valve fits in the aortic root (the sinus of Valsalva). The results of a clinical study conducted in Europe were submitted to evaluate the efficacy and safety of the product in patients with aortic valve stenosis or aortic valve stenosis and regurgitation requiring AVR. |
| Jun 4, 2018 | miraDry SystemMicrowave scalpel | JMEC Co., Ltd. | New device | Oct 25, 2013 | 55 mo later | 363 days | The device used to ablate and coagulate eccrine glands through microwave heating of the deep dermal layer of skin for the treatment of severe primary axillary hyperhidrosis. The handpiece of the product functions to cool the surface of the skin to prevent damage caused by the heat. The results of foreign clinical studies using the previous-generation products were submitted to evaluate the efficacy in severe primary axillary hyperhidrosis and the acceptability of the anticipated adverse events in comparison with the efficacy. |
| Jun 1, 2018 | Juvederm Vista Volift XCInjectable material to a soft tissue using hyaluronic acid | Allergan Japan K.K. | New device | Mar 17, 2017 | 14 mo later | 430 days | An injectable material to a soft tissue using hyaluronic acid to be injected into the middle and deep dermis to correct moderate to severe wrinkles and folds in the facial skin. The improved point is that a lower concentration of the hyaluronic acid gel of the company’s approved product 1, "Juvederm Vista Voluma XC" (22800BZX00338000) used for correcting volume deficit, is used for optimal correction of wrinkles and folds. The results of a foreign clinical study were submitted to evaluate the efficacy and safety of the impact of the improved point on the correction of wrinkles and folds. |
| May 25, 2018 | Dexcom G4 PLATINUM SystemGlucose monitoring system | Dexcom, Inc. | New device | Oct 5, 2012 | 68 mo later | 428 days | The device is a continuous glucose monitoring system indicated for detecting trends and tracking patterns by measuring interstitial fluid glucose concentration in persons with diabetes. The device continuously records interstitial fluid glucose concentration obtained by a sensor that is inserted subcutaneously and displays the collected information on a monitor. Patterns and trends of interstitial fluid glucose concentration obtained by the device can be used to optimize the management of diabetes. It is used to complement self-blood glucose monitoring. The results of foreign clinical studies were submitted to evaluate the efficacy and safety of this product. |
| May 24, 2018 | PLATINIUM SonR CRT-DImplantable biventricular pacing pulse generator with defibrillator function | Sorin CRM SAS | New device | Not listed | — | 265 days | An implantable biventricular pacing pulse generator with defibrillation function to supply an appropriate defibrillation pulse to the myocardium to reduce the heart rate to the normal range as necessary when tachycardia is detected, and to supply a pacing pulse to increase the heart rate to the normal range when bradycardia is detected. This device was developed based on the approved product, "PLATINIUM CRT-D" (Approval No. 22800BZI00022000). A major improved point is the addition of a CRT optimization function to automatically regulate AV and VV delays according to the endocardial acceleration signals from the acceleration sensor equipped in "SonRtip lead" (Approval No. 23000BZI00013000), which is used in combination with the device. The results of a foreign clinical study were submitted to evaluate the efficacy and safety of the CRT optimization function. |
| May 24, 2018 | SonRtip leadImplantable defibrillator/ pacemaker lead | Sorin CRM SAS | New device | Not listed | — | 265 days | A pacemaker lead with an acceleration sensor to convert endocardial acceleration into electrical signals equipped in the tip, which is used as an atrial pacing lead for "PLATINIUM SonR CRT-D" (Approval No. 23000BZI00012000) with CRT optimization function. The results of a foreign clinical study were submitted to evaluate the efficacy and safety of the CRT optimization function. |
| May 18, 2018 | Mediostar Next ProDiode laser | Medical U&A, Inc. | New device | Mar 10, 2015 | 38 mo later | 259 days | The device is intended to achieve stable long-term hair reduction by selective photothermolysis. Diode lasers at wavelengths of 808 nm and 940 nm are delivered simultaneously. A clinical evaluation report summarizing clinical literatures on the previous generation product was submitted to evaluate the long-term hair reduction effect and the absence of permanent adverse events. |
| May 7, 2018 | Long-Pulsed Laser GentleMax ProNeodymium:YAG laser | Syneron Candela K.K. | New device | Dec 26, 2013 | 52 mo later | 138 days | The device intended to achieve stable long-term hair reduction by selective photothermolysis. The device is a combination device with which 755 nm Alexandrite laser or 1064 nm Nd:YAG laser can be selected. The functions of the Alexandrite laser are the same as those of the company’s previous model, "Long-Pulsed Alexandrite Laser GentleLase Pro" (Approval No. 22800BZX00446000). A clinical evaluation report summarizing clinical literatures on the previous generation product was submitted to evaluate the long-term hair reduction effect and the absence of permanent adverse events. |
| May 2, 2018 | Mobi-C Artificial Cervical DiscTotal disc replacement prothesis | Zimmer Biomet G.K. | New device | Aug 23, 2013 | 56 mo later | 356 days | An artificial cervical disc to restore the functions of one disc or two adjacent discs in the cervical vertebrae (C3 to C7). The product consists of cobalt chromium molybdenum alloy endplates coated with plasma sprayed titanium and hydroxyapatite coating and an ultra-high molecular weight polyethylene mobile bearing insert. The results of foreign clinical studies were submitted to verify the non-inferiority of the treatment using this product to the conventional therapy of anterior cervical discectomy and fusion (ACDF). |
| Apr 26, 2018 | Comprehensive Shoulder NanostemHumeral component for shoulder prosthesis | Zimmer Biomet G.K. | New device | Not listed | — | 121 days | A humeral stem component system used proximally in the humerus to substitute for shoulder joint functions during total shoulder arthroplasty or shoulder humeral head replacement. The improved point is the adoption of a humeral stem that is shorter than the conventional one to reduce the invasiveness to the bone marrow cavity, thereby allowing bone preservation. A clinical evaluation report summarizing the contents of foreign clinical literatures, post-marketing surveillance, and malfunction reports was submitted to evaluate the risks of looseness, dislocation, etc. caused by this improved point. |
| Apr 24, 2018 | Hemodiafilter FX HDFHemodiafilter | Fresenius Medical Care Japan K.K. | New device | Not listed | — | 109 days | A hemodiafilter used to remove fluid and uremic substances stored in the body due to uremia. This device is indicated for patients with extremely impaired renal function caused by chronic or acute kidney failure. The improved point is that the product uses a semi-permeable membrane that is identical to the one used in the company’s approved product, a hollow fiber dialyzer "Fresenius Dialyzer FX Series (Approval No. 22000BZX00037000)", as a hemodiafilter to meet market needs. |
| Apr 23, 2018 | Misago 2Stent for iliac artery | Terumo Corporation | New device | May 22, 2015 | 35 mo later | 257 days | A nickel-titanium alloy vascular stent used for vascular expansion and maintenance of a lumen in symptomatic artery disease of the iliac arteries and the superficial femoral artery region, and for the treatment of acute or impending occlusion associated with unsuccessful intervention treatment of the superficial femoral artery region. Sharing the basic design with the approved product, "Misago" (Approval No. 22400BZX00463000), a stent for use in superficial femoral arteries, Misago 2 has an additional sized model with a wider diameter for iliac artery. The results of a clinical study of the product for use in the iliac arteries and the superficial femoral artery region were submitted to evaluate the efficacy and safety of the product. |
| Apr 17, 2018 | EBL DeviceDevice for endoscopic loop ligation | Akita Sumitomo Bakelite Co., Ltd. | New device | Not listed | — | 183 days | A medical device to be mounted on the end of an endoscope, and that is intended to be used to ligate internal hemorrhoids or colonic diverticular bleeding points with an O ring by drawing them into the device. Ligation of tissues with an O ring stops bleeding and causes tissue necrosis to block the diverticula. The device was developed by improving the company’s approved product, “Pneumatic EVL Device (with cuff)” (Approval No. 22100BZX01110000), an endoscopic esophageal varix ligation set, and is designed for use in the large intestine. Three different sizes are available depending on the size of the endoscope. |
| Apr 10, 2018 | PELNAC G plusCollagen-based artificial skin | GUNZE Limited | New device | Not listed | — | 256 days | PELNAC G plus is a bilayer collagen-based artificial dermis made of a gelatin-containing collagen sponge and a silicone film. This product is based on the company's approved product, “PELNAC” and its improvements are the inclusion of gelatin in the raw material as well as the introduction of a single-layer fenestrated type. The results of a single-arm clinical study on patients with refractory skin ulcers in Japan were submitted to evaluate the efficacy and safety of this product. |
| Apr 4, 2018 | Oncomine Dx Target Test CDx SystemSystem for analysis of somatic variants (for eligibility identification of antineoplastic agents) | Life Technologies Japan Ltd. | New device | Jun 22, 2017 | 9 mo later | 310 days | A companion diagnostic system used to determine if dabrafenib mesylate in combination with trametinib dimethyl sulfoxide are indicated based on a V600E mutation in the BRAF gene in patients with non-small cell lung cancer (NSCLC). The system consists of template DNA preparation reagents, a DNA sequencer, and an analysis program. As a study used to evaluate the clinical utility of the product, the result from a foreign study assessing the equivalence between this product and the test method used for the inclusion of subjects in a phase II study of above drugs were submitted. |
| Apr 4, 2018 | XIENCE Sierra Drug Eluting StentCoronary stent | Abbott Vascular Japan Co., Ltd. | New device | May 22, 2018 | 2 mo earlier | 182 days | A stent system consisting of a drug-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a de novo coronary lesion (a lesion length of 32 mm or less) with a reference vessel diameter of 2.25-4.25 mm and a delivery catheter used to implant the stent to the site of stenosis. The product was developed by slightly changing the design of the stent and changing the design of the delivery system to improve deliverability from those of the company’s approved product, "XIENCE Alpine Drug Eluting Stent" (Approval No. 22600BZX00529000). The results of Japanese and foreign clinical studies were attached to evaluate the efficacy and safety of the product. |
| Mar 29, 2018 | BRACAnalysis diagnostic systemSoftware for analysis of germline variants (for eligibility identification of antineoplastic agents) | Myriad Genetic Laboratories, Inc. | New device | Dec 19, 2014 | 39 mo later | 163 days | A companion diagnostic program used to determine if olaparib is indicated based on BRCA mutation data in patients with breast cancer. As a study used to evaluate the clinical utility of the product, the result from a foreign study assessing the equivalence between this product and the test method used for the inclusion of subjects in a phase III study of olaparibt were submitted. |
| Feb 28, 2018 | Trabecular Metal Ankle SystemTotal ankle prosthesis | Zimmer Biomet G.K. | New device | Aug 24, 2012 | 66 mo later | 258 days | A hinge-type titanium bridge made of titanium is used to fix the thyroid cartilage with the incision gap made during type II thyroplasty to improve symptoms of adductor spasmodic dysphonia. While there has been no relatively less invasive and permanent treatment for adductor spasmodic dysphonia, the product realized the treatment based on a novel principle and its development for early commercialization was anticipated in Japan ahead of the rest of the world. Therefore, the product has been designated as an item to be reviewed under the sakigake designation fast- track review system. The results of an investigator-initiated clinical study conducted in Japan were submitted to evaluate the safety and clinical efficacy of the product. [SAKIGAKE designation, Orphan device] |
| Feb 27, 2018 | Aktis ToricPosterior chamber lens | Nidek Co., Ltd. | New device | Not listed | — | 263 days | The product is a single-piece-type monofocal posterior chamber lens intended to be inserted into the aphakic eye of patients with corneal astigmatism after cataract surgery. The shape other than the optic is similar to the company's approved product, "Nex-Acri AA 1P" (Approval No. 22100BZX00945000). The improved points are the change of raw material compositions and the addition of cylindrical power for the correction of corneal astigmatism. The results of a Japanese clinical study were submitted to evaluate the clinical efficacy, including an astigmatism correction function, and safety of the device. |
| Feb 9, 2018 | Bactiseal Shunt CatheterCerebrospinal catheter | Johnson & Johnson K.K. | New device | Oct 1, 2001 | 196 mo later | 266 days | A cerebrospinal catheter intended to be placed in the body as a component of a shunt system for treatment of hydrocephalus by leading excessive cerebrospinal fluid from the central nervous system to other absorptive sites in the body using a cerebrospinal fluid shunt. The device is impregnated with rifampicin and clindamycin hydrochloride to inhibit colonization of bacteria that stick to the catheter surface. It was selected as an item for early introduction at the "Japanese Ministry of Health, Labour and Welfare's Panel of experts meeting on early introduction of highly needed medical devices" on August 9, 2013. A clinical evaluation report summarizing such materials as foreign literature was submitted for safety evaluation. |
| Feb 2, 2018 | ProntosanAntibacterial wound dressing | B. Braun Medical AG | New device | May 17, 2009 | 105 mo later | 310 days | Antibacterial gel dressing for wounds reaching the subcutaneous adipose tissue (excluding third-degree burns) to "protect wounds," "moisten wound bed," "accelerate healing," and "alleviate pain." Ingredients of the product include polyhexanide, which has been used as a disinfectant in clinical practice, in expectation of the effect of preventing bacterial infection and diffusion in the wounds. The results of a foreign clinical study were submitted to confirm the efficacy and safety of the product as a wound dressing consisting of new raw materials, and the absence of delayed healing due to the polyhexanide content. |
| Jan 19, 2018 | Orsiro Sirolimus Eluting Coronary Stent SystemCoronary stent | Biotronik Japan, Inc. | New device | Not listed | — | 374 days | A stent system consisting of a sirolimus-eluting stent used for treating patients with symptomatic ischemic cardiac disease who have a new coronary artery lesion (a lesion length of 26 mm or less) with a reference vessel diameter of 2.25 mm to 4.0 mm and a delivery catheter to place the stent at the site of stenosis. The stent platform made of cobalt chromium is coated with hydrogenated amorphous silicon carbide that inhibits metal ion release. The drug coating layer is composed of sirolimus and bioabsorbable PLLA. The results of Japanese and foreign clinical studies were submitted to evaluate the efficacy and safety of this device. |
| Dec 26, 2017 | CO2RE Carbon Dioxide Laser with Fractional ModeInstrument & | Syneron Candela K.K. | New device | Nov 9, 2010 | 86 mo later | — | A carbon dioxide laser intended for ablation of soft tissue for skin resurfacing. The device has a computer-controlled scanner by which uniform ablation is feasible based on the pattern that is selected by the physician in advance. It also has a mode of fine fractional laser irradiation. Improved points include improved safety compared to the conventional laser scalpel by smaller spots ablation instead of larger area ablation on the skin, to expand its applications to various purposes including cosmetic improvement. The product is equipped with a mode that allows its use for other purposes as a laser scalpel, similarly to conventional carbon dioxide lasers. A clinical assessment report, consisting of the results of a foreign clinical study of the device and clinical papers of similar products was submitted to evaluate that the |
| Dec 15, 2017 | CoolSculpting Control UnitInstrument and device for cooling therapy | JMEC Co., Ltd. | New device | Sep 15, 2010 | 87 mo later | 434 days | A device intended to partially reduce the fat layer thickness by cooling of the subcutaneous fat without surgical invasion for cosmetic reasons. This device is used with dedicated applicators and consumables such as liners and gel pads. The dedicated applicators include vacuum applicators that vacuum the skin and subcutaneous fat while cooling them, and a non-vacuum applicator. The results of foreign clinical studies were submitted to evaluate the efficacy of the product for fat thickness reduction and the risks of complications. |
| Dec 15, 2017 | TITANBRIDGEFixture for thyroid cartilage | Nobelpharma Co., Ltd. | New device | Not listed | — | 168 days | A hinge-type titanium bridge made of titanium is used to fix the thyroid cartilage with the incision gap made during type II thyroplasty to improve symptoms of adductor spasmodic dysphonia. While there has been no relatively less invasive and permanent treatment for adductor spasmodic dysphonia, the product realized the treatment based on a novel principle and its development for early commercialization was anticipated in Japan ahead of the rest of the world. Therefore, the product has been designated as an item to be reviewed under the sakigake designation fast-track review system. The results of an investigator-initiated clinical study conducted in Japan were submitted to evaluate the safety and clinical efficacy of the product. [SAKIGAKE designation, Orphan device] |
| Dec 14, 2017 | GC Cytrans GranulesResorbable dental bone reconstruction implant material | GC Corporation | New device | Not listed | — | 212 days | The device is a resorbable dental implant material for bone reconstruction consisting of granular carbonate apatite used for compensation of a bone defect of the maxilla, mandible, and alveolar bone. The results of a Japanese clinical study of the efficacy and safety of the product when concurrently used with a dental implant fixture were submitted. |
| Dec 8, 2017 | TMP OcclusionEmboli-capturing catheter in the central circulatory system | Tokai Medical Products, Inc. | New device | Not listed | — | 161 days | An emboli-capturing catheter for carotid artery stenting and acute cerebral revascularization and so forth prevent distal embolization of cerebrovascular vessels, and the catheter has a balloon at its tip. A clinical assessment report prepared based on clinical literature reports of the device and similar products, was submitted to indicate the equivalence of the device to approved products. |
| Dec 7, 2017 | Mpact DM Acetabular ComponentArtificial hip joint, acetabular component | Medacta Japan Co., Ltd. | New device | Mar 2, 2015 | 33 mo later | 90 days | The acetabular component for an artificial hip intended to replace or restore the acetabulum during hip replacement (including reimplantation), consisting of a stainless steel cup and liner made of ultra-high molecular weight polyethylene. The contact surface of the cup and acetabular roof is treated with pure titanium flame spray, and the liner is treated with crosslinking. Since the device is the first double mobility system of this company with sliding surfaces both on the in- and outside of the liner, a clinical assessment report based on a foreign clinical study of the device and foreign clinical literature on the previous generation of the product, demonstrating equivalence to this device, were submitted to confirm that the product has similar efficacy and safety to a conventional artificial hip. |
| Dec 7, 2017 | Menicon Rose K-TReusable colored contact lenses for correcting visual acuity | Menicon Co., Ltd. | New device | Not listed | — | 261 days | An oxygen-transmissible daily wear hard contact lens intended to correct visual acuity in patients with keratoconus and associated myopia and hyperopia. The improved points are that the lens blanks of products made of the same raw materials as the company's approved product, "Menicon Tinu," (21800BZZ10125000) are formed to enable patients with keratoconus to wear the lenses, and that indications are made clear in the intended use. |
| Dec 4, 2017 | Philips IntelliSite Pathology SolutionDiagnostic auxiliary equipment for whole-slide imaging in pathology | Philips Japan, Ltd. | New device | Apr 13, 2017 | 8 mo later | 187 days | A system for preparation and storage of whole- slide images in pathology and assisting pathological diagnosis, consisting of a scanner for image reading and an image management system. In addition, remote pathological diagnosis is feasible by connecting to an external network. A clinical assessment report summarizing the results of foreign clinical studies was submitted to confirm the equivalenece between the diagnositic result using this product and existing light microscope. |
| Nov 29, 2017 | AirSeal Intelligent Flow SystemAir and water supply device for endoscopy | Conmed Japan KK | New device | Mar 20, 2015 | 32 mo later | 184 days | An air and water supply device for endoscopy intended to secure adequate space and visualization of the surgical field required for examination and surgery by insufflating CO2 gas into the peritoneal cavity, or retroperitoneal space and rectum to extend the space in the applicable area while eliminating smoke during endoscopy and surgery or transanal rectal surgery. The insufflation of CO2 gas into the retroperitoneal space or rectum to aid surgery by securing the visual field has been added to the intended use or effects, and thereby makes the product available for transanal total mesorectal excision (taTME) of all layers of rectal cancer or transanal minimally invasive surgery (TAMIS) for some procedures such as mucosal stripping from the gut lumen using a rigid endoscope. A clinical assessment report summarizing the foreign literature was submitted to evaluate the efficacy and safety of insufflation into the retroperitoneal space and rectum at the implementation of taTME or TAMIS. |
| Nov 27, 2017 | Clareon Aspherical Hydrophobic Acryl Intraocular LensPosterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 262 days | A monofocal posterior chamber lens to be inserted as a substitute for a crystalline lens in the posterior chamber to correct visual acuity of an aphakic eye. The shape of the product is a one-piece type, consisting of the same raw materials in the optic and haptic. The product is a cross-linked acrylic copolymer containing the same ultraviolet and blue light-absorbing agents as the company's approved product, "Alcon AcrySof Natural Single Piece" (21800BZY10066000). The improved point is that flexibility and maneuverability are increased by changing the composition of the major component monomers. |
| Nov 24, 2017 | Toray Filtryzer BKHollow-fiber dialyzer | Toray Industries, Inc. | New device | Not listed | — | 269 days | A hollow-fiber dialyzer used to remove fluid and uremic substances stored in the body due to uremia. This device is indicated for patients with extremely impaired renal function caused by chronic or acute kidney failure. The improved points are the addition of some materials to the raw materials of hollow fiber used for the approved product, "Filtryzer BK," (Approval No. 15900BZZ01740000) and myoglobin clearance as a specification for performance. Since equivalence of the raw materials of dialysis membranes for the device and those for the approved product was not confirmed, the results of a Japanese clinical study for safety evaluation were submitted in accordance with PFSB Notification No. 0301-5 dated on March 1, 2013. |
| Nov 24, 2017 | Toray Filtryzer BGHollow-fiber dialyzer | Toray Industries, Inc. | New device | Not listed | — | 269 days | A hollow-fiber dialyzer used to remove fluid and uremic substances stored in the body due to uremia. This device is indicated for patients with extremely impaired renal function caused by chronic or acute kidney failure. The improved points are the addition of some materials to the raw materials of hollow fiber used for the approved product, "Filtryzer BG," (Approval No. 20700BZZ00293000) and myoglobin clearance as a specification for performance. Since equivalence of the raw materials of dialysis membranes for the device and those for the approved product was not confirmed, the results of a Japanese clinical study for safety evaluation were submitted in accordance with PFSB Notification No. 0301-5 dated on March 1, 2013. |
| Nov 24, 2017 | Noninvasive Transtympanic Pressure Device EFET01Transtympanic pressure device | Daiichi Medical Co., Ltd. | New device | Not listed | — | 269 days | A device intended to inhibit vertiginous attacks due to Meniere's disease and delayed endolymphatic hydrops by non-invasively adding pressure to the middle ear cavity through the external auditory canal to facilitate excretion of endolymphatic fluid that has accumulated in the inner ear, consisting of an air pressure generating device, a tube with ear plugs to add pressure and a power supply. The improved point is increased reproducibility of the waveform by detailed specification of the parameters of the air pressure wave to efficiently add pressure to the middle ear space, compared to certified tympanum massagers. |
| Nov 16, 2017 | Hemodynamic Monitor HDM-3000Multi-item patient monitor | Nihon Kohden Corporation | New device | Not listed | — | 324 days | A multi-item monitor intended to display patient's vital signs (e.g. electrocardiogram, blood pressure, and oxygen saturation) on a screen, generate alarms, and provide continuous cardiac output estimated by a non-invasive parameter, pulse wave transit time under conditions of relatively stable hemodynamics. It is a device that is based on "Bedside Monitor: BSM-3000 Series, Life Scope VS," the previous generation device (Certification No. 22300BZX00245000), and has the added feature that it can calculate and display estimated continuous cardiac output (esCCO). esCCO is calculated by continuous pulse waves obtained by electrocardiography and pulse oximetry measurement, and calibrated by blood pressure and cardiac output known or calculated based on patient data such as body weight. The results of a clinical comparative study of the approved product, "Vigileo Monitor" (Approval No. 21700BZY00328000), as the control were submitted as materials to evaluate the clinical safety and efficacy of the function of calculating esCCO. |
| Nov 10, 2017 | COOK Zenith Alpha Thoracic Endovascular GraftAortic stent graft | Cook Japan Inc. | New device | Sep 15, 2015 | 26 mo later | 477 days | An aortic stent graft used for endovascular treatment of thoracic aortic aneurysm, consisting of the stent graft and the delivery system. Based on the structure of the company's approved product, "COOK Zenith TX2 TAA Endovascular Graft" (Approval No. 22300BZX00147000), the raw material of the stent was changed from stainless steel to nitinol, the flexibility of the stent graft was increased by thinning the graft material, and the external diameter of the delivery catheter was reduced. The results of a global clinical trial were submitted to evaluate the efficacy and safety of the product for thoracic aortic aneurysm. |
| Nov 2, 2017 | Tecnis Symfony Toric VBMultifocal posterior chamber lens | AMO Japan K.K. | New device | Not listed | — | 133 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision of an aphakic eye with corneal astigmatism. The shape and structure of the device are similarly designed as "Tecnis Symfony Toric", which has a diffractive multifocal mechanism and toric structure (Approval No. 22900BZX00359000), and ultraviolet and violet light-absorbing agents were added to the raw materials. |
| Nov 2, 2017 | Tecnis Symfony ToricMultifocal posterior chamber lens | AMO Japan K.K. | New device | Jul 15, 2016 | 16 mo later | 258 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision of an aphakic eye with corneal astigmatism. The posterior optical zone has the same diffractive multifocal mechanism as the company's approved product, "Tecnis Symfony" (Approval No. 22900BZX00006000). The anterior optical zone has an aspherical surface similar to the company's approved product, "Tecnis Toric One- piece" (Approval No. 22500BZX00363000). The improved point is that it has combined optical functions of the company's approved products. |
| Nov 2, 2017 | Claria MRI CRT-D SeriesImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd. | New device | Oct 25, 2016 | 12 mo later | 247 days | The device is an implantable biventricular pacing pulse generator with a defibrillator function. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. It is a higher-end model of the company's approved product, "Amplia MRI CRT- D Series" (Approval No. 22800BZX00219000). The major differing point is an additional feature whereby the device evaluates the efficacy of pacing with CRT during atrial fibrillation (AF), and adjusts the pacing rate based on the evaluation results (EffectivCRT during AF feature). The results of a foreign clinical study were submitted to evaluate the efficacy and safety of the EffectivCRT during AF feature. |
| Oct 31, 2017 | Hot AXIOS SystemProsthesis for pancreatic fistulation | Boston Scientific Japan K. K. | New device | Aug 5, 2015 | 27 mo later | 154 days | A system intended to form a fistula in the wall of the gastrointestinal tract and cyst through the gastrointestinal tract with endoscopic ultrasound for treatment of the cyst with accumulation of exudate and necrotic material in a pancreatic pseudocyst or walled-off necrosis associated with acute pancreatitis including acute exacerbation of chronic pancreatitis. The system consists of a prosthesis for pancreatic fistulation and a delivery system. The results of a foreign clinical study for investigation of the efficacy and safety of the device in patients in whom endoscopic drainage is indicated were submitted. |
| Oct 31, 2017 | MitraClip NT SystemPercutaneous repair system for mitral valve coaptation failure | Abbot Vascular Japan Co., Ltd. | New device | May 10, 2016 | 18 mo later | 368 days | The system is intended to reduce mitral regurgitation (MR) by coapting the anterior and posterior leaflets of the mitral valve using a percutaneously inserted clip. The results of a foreign clinical study comparing the percuntaneous reduction by this system with surgery in operable patients, and Japanese and foreign clinical studies in patients with severe MR who have been determined to be at high risk for mitral valve surgery were submitted. |
| Oct 16, 2017 | Compress SystemArtificial material for lower limb reconstruction | Zimmer Biomet G.K. | New device | Aug 5, 2005 | 146 mo later | 108 days | An artificial material for lower limb reconstruction intended to reconstruct lower limb function with prosthesis of the defective part of the bone, in patients who had undergone extensive bone resection, due to conditions such as malignant tumor. The structure of the system provides compressive stress on the bone-implant interface, and reduces stress shielding which is caused by the placement of implant. The device does not include a stem, and is therefore available for use in patients where necessary length of the stem for bone implant cannot be ascertained. A clinical assessment report including the results of a clinical study with follow- up in the U.S., and reports from foreign clinical literature, were submitted to demonstrate similar efficacy and safety of the product to existing artificial joints for cancer patients. |
| Oct 10, 2017 | NeuRx Diaphragm Pacing System (DPS)Phrenic nerve stimulator | USCI Japan Ltd. | New device | Jun 17, 2008 | 112 mo later | 1117 days | A diaphragm pacer that supports respiratory movement of the diaphragm by electrical stimulation to the phrenic nerve through motor points on the diaphragm in patients with respiratory failure due to diaphragmatic dysfunction of central nervous or neurogenic origin. The device is used for respiratory support in patients with ventilator-dependent spinal cord (cervical) injury or central hypoventilation syndrome. The results of a foreign clinical study for evaluation of the efficacy and safety of the device were submitted. |
| Sep 29, 2017 | NeuroStar TMS Therapy SystemRepetitive transcranial magnetic stimulator | Neuronetics,Inc. | New device | Oct 7, 2008 | 108 mo later | 1127 days | A therapy system utilizing Repetitive Transcranial Magnetic Stimulation for the treatment of adult patients with Major Depressive Disorder (MDD) who have not benefitted from conventional antidepressant medication. The results from foreign clinical studies were submitted to evaluate the efficacy and safety of this product. |
| Sep 15, 2017 | GORE VIABAHN VBX Balloon Expandable EndoprosthesisStent graft with heparin for central circulatory system | W. L. GORE & Associates, Co., Ltd. | New device | Jan 27, 2017 | 8 mo later | 267 days | A stent graft system which consists of a balloon expandable stent graft made of stainless steel and delivery catheter used to treat de novo or restenotic lesions found in iliac arteries. The inside and outside of the stent are fused with a PTFE film which has a heparin bonding layer. The results from a foreign clinical study using this product were submitted as clinical evaluation data. |
| Sep 6, 2017 | IN.PACT Admiral Drug-Coated Balloon (DCB) CatheterBalloon-dilating catheter for angioplasty | Medtronic Japan Co., Ltd. | New device | Dec 30, 2014 | 32 mo later | 342 days | A balloon-dilating catheter for angioplasty used for purposes including reducing restenosis of target blood vessels in de novo or non-stented restenotic lesions in the superficial femoral or popliteal arteries. The balloon surface of this product is coated with paclitaxel as drug. The results from a foreign pivotal study conducted to evaluate the performance of the product and those from a Japanese study conducted to investigate whether the pivotal data can be extrapolated to Japanese population were submitted. |
| Aug 31, 2017 | BC SwiveLock Tenodesis ScrewAbsorbable ligament fixation | Arthrex Japan G.K. | New device | Sep 15, 2011 | 72 mo later | 125 days | An absorbable ligament anchor made of poly-L- lactic acid/β-tricalcium phosphate composite used to attach the stump of soft tissues, such as ligaments and tendons, or artificial ligaments to bones. There have been no Japanese approvals of medical devices using the raw material. Therefore the results from a Japanese open study conducted to evaluate the safety and efficacy for rotator cuff repair using the company’ s similar devices “BC SwiveLock Screw” and “BC Corkscrew FT Anchor” which use the raw material, were submitted as clinical study data. |
| Aug 31, 2017 | Avalus BioprosthesisBovine pericardial valve | Medtronic Japan Co., Ltd. | New device | Jul 31, 2017 | 1 mo later | 262 days | A bovine pericardial valve to be used to substitute for the function of a malfunctioning native or prosthetic aortic valve. The biological valve has a frame made of polyetheretherketone and a valve leaflet treated with alpha-amino oleic acid for anticalcification. It was developed aiming at the safety of MRI and reductions of permanent deformations and corrosion risk when assuming future valve in valve procedures are performed, by using non-metallic components. The results of clinical studies conducted in EU, US, and Canada were submitted to evaluate the efficacy and safety of this product in patients with aortic valve stenosis requiring aortic valve replacement. |
| Aug 22, 2017 | BC SwiveLock ScrewAbsorbable ligament fixation | Arthrex Japan G.K. | New device | Jan 7, 2011 | 79 mo later | 264 days | An absorbable ligament fixation used to attach the stump of soft tissues, such as ligaments and tendons, or artificial ligaments to bones. As a raw material for the absorbable screw, poly-L-lactic acid/β-tricalcium phosphate composite is adopted. Until now, there have been no approvals of products for which β-tricalcium phosphate is added to poly-L-lactic acid. Therefore the results from a Japanese open study conducted to evaluate the safety and efficacy for rotator cuff repair using this device and “BC Corkscrew FT Anchor” for which an application was made simultaneously, were submitted as clinical study data. |
| Aug 21, 2017 | BC Corkscrew FT AnchorAbsorbable ligament fixation | Arthrex Japan G.K. | New device | Jan 23, 2009 | 103 mo later | 263 days | An absorbable ligament fixation made of poly-L- lactic acid/β-tricalcium phosphate composite used to attach the stump of soft tissues, such as ligaments and tendons, or artificial ligaments to bones. There have been no Japanese approvals of medical devices using the raw material. Therefore the results from a Japanese open study conducted to evaluate the safety and efficacy for rotator cuff repair using this device and “BC SwiveLock Screw” for which an application was made simultaneously, were submitted as clinical study data. |
| Aug 14, 2017 | COOK Evolution RL Controlled- Rotation Dilator Sheath SetPacemaker/ defibrillator lead removal kit | Cook Japan Inc. | New device | Jul 1, 2014 | 37 mo later | 255 days | A pacemaker/defibrillator lead removal kit used for transvenous lead removal of implantable pacemaker leads, implantable defibrillator leads, etc. It was developed based on the approved product “COOK Lead Extraction System” (Approval No. 22700BZX00054000). Changes were made to unidirectional or bidirectional rotation of the inner sheath by handle operation and to a stainless-steel tip on the end of the inner sheath. A clinical evaluation report summarizing foreign literatures reporting this device or the previous generation device was submitted to evaluate the efficacy and safety of this device. |
| Aug 3, 2017 | Lutonix Drug-Coated Balloon (DCB) Catheter (for femoropopliteal arteries)Balloon-dilating catheter for angioplasty | Medicon, Inc. | New device | Oct 9, 2014 | 34 mo later | 486 days | A balloon-dilating catheter for angioplasty used for purposes including reducing restenosis of target blood vessels in the treatment of de novo or restenotic lesions within the autogenous femoropopliteal artery (excluding those within a stent). The balloon surface of this product is coated with a drug composed of paclitaxel and excipients, polysorbate and sorbitol. The results from a foreign pivotal study conducted to evaluate the performance of the product and those from a Japanese study conducted to investigate whether the pivotal data can be extrapolated to Japanese population were submitted. |
| Aug 1, 2017 | BioFreedom Drug-Coated StentCoronary stent | Biosensors Japan Co., Ltd. | New device | Not listed | — | 412 days | A stent system consisting of a biolimus-coated stent and a delivery catheter for the treatment of patients with symptomatic ischemic heart disease, with de novo coronary lesions of a lesion length of 33 mm or less, and with a reference vessel diameter of 2.25-4.0 mm in size. Without the use of polymer, biolimus A9 is directly coated to the stainless steel which has a selectively micro-structured surface. The drug is absorbed in about 1 month, after which becomes a bare metal stent. This stent was developed to allow discontinuation of dual antiplatelet therapy in one month, similarly to bare metal stents. The results from Japanese and foreign clinical studies were submitted to evaluate the efficacy and safety of this device. |
| Jul 27, 2017 | Vascular Stent-1Stent for iliac artery | Covidien Japan, Inc. | New device | Not listed | — | 231 days | An iliac arterial stent system available in nominal stent sizes of 6, 7 and 8 mm diameters for maintaining vascular patency of atherosclerotic lesions in the iliac arteries. The results from foreign clinical studies were submitted to evaluate the efficacy and safety of this device. |
| Jul 27, 2017 | Vascular Stent-2Stent for iliac artery | Covidien Japan, Inc. | New device | Jan 21, 2015 | 30 mo later | 231 days | An iliac arterial stent system available in nominal stent sizes of 9, 10 and 12 mm diameters for maintaining vascular patency of atherosclerotic lesions in the iliac arteries. The results from foreign clinical studies were submitted to evaluate the efficacy and safety of this device. |
| Jul 24, 2017 | Naída CICochlear implant system | Nihon Kohden Corporation | New device | Aug 14, 2015 | 23 mo later | 270 days | A sound processor that constitutes the cochlear implant system used in patients with bilateral severe hearing loss who have not responded sufficiently to wearing hearing aids. The basic performance of the product is equivalent to that of the approved Auria harmony sound processor for “HiRes Auria Sound Processor” (Approval No. 22000BZY00009000). A power saving method based on the approved method of audio signal processing was added to this device. The results from a clinical study conducted in the United States were submitted to evaluate the efficacy and safety of this device. |
| Jul 6, 2017 | Episil Oral LiquidWound dressing and protecting hydrogel material for topical management | Solasia Pharma K.K. | New device | Sep 13, 2011 | 70 mo later | 267 days | The product is used for management and relief of oral pain by covering and protecting lesions/stomatitis associated with chemotherapy and/or radiotherapy. The bioadhesive oral liquid consists of lipid components such as glycerol dioleate and soy phosphatidylcholine wituout "active medicinal (pharmacuetical) components. The liquid forms a protective bioadhesive layer by the uptake of aqueous fluid i.e saliva. The results from a foreign clinical study were submitted to evaluate the efficacy and safety of the product. |
| Jun 27, 2017 | V.A.C. Ulta Wound Therapy SystemNegative pressure wound therapy system | KCI KK | New device | Sep 17, 2010 | 81 mo later | 256 days | V.A.C. Ulta Therapy System is a negative pressure wound therapy (NPWT) system with wound cleaning function to be used for patients with refractory wounds which have not responded to and/or are considered unlikely to respond to the conventional NPWT. This device can also be used for wounds with local infection using its function to instill wound- cleansing solutions automatically and periodically to optimize the wound surface environment and clean wounds. Furthermore, it can also be used as a local NPWT without using the function of periodic and automatic instillation. The results of a Japanese clinical study were submitted to evaluate the efficacy and safety in patients with refractory wounds associated with contamination or local infection. |
| Jun 20, 2017 | EDWARDS INTUITY Elite Valve System (Edwards Lifesciences Limited ) HeartLight Endoscopic Ablation SystemBovine pericardial valve Instrument Cardiovascular & ablation catheter | Japan Lifeline Co., Ltd. | New device | Aug 12, 2016 | 10 mo later | 356 days | This device is a system to surgically deliver a biological valve to the aortic valve position, and has a structure added with cloth-covered frame for fixation to the company’s approved product “Carpentier-Edwards Bovine Pericardial Biological Valve Magna EASE ThermaFix Process” (Approval No. 22300BZX00320000) to enable the valve to be transplanted with fewer sutures than existing valves for conventional aortic valve replacement (AVR). The results of a clinical study conducted in the United States were submitted to evaluate the efficacy and safety of the device in patients with aortic stenosis or aortic stenosis with insufficiency, both requiring AVR. An ablation system utilizing laser for performing percutaneous transluminal myocardial ablation to treat drug-resistant recurrent symptomatic paroxysmal atrial fibrillation. The system consists of a balloon catheter, console, endoscope fiber, solution to expand balloon catheter and accessories. The results from a US clinical study conducted to verify the efficacy and safety of this product in patients with drug-resistant recurrent symptomatic paroxysmal atrial fibrillation and compared with the safety and efficacy of a radiofrequency ablation catheter were submitted. |
| Jun 9, 2017 | Resolute Onyx Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Apr 28, 2017 | 1 mo later | 221 days | A stent system consisting of a zotarolimus-eluting stent used for treating patients with symptomatic ischemic cardiac disease who have a new coronary artery lesion (a lesion length of 35 mm or less) with a reference vessel diameter of 2.25- 4.2 mm and a delivery catheter to place the stent at the site of stenosis. The deliverability was improved by reducing the thickness of the stent strut to lower crossing profile as compared to that of the previous product “Resolute Integrity Coronary Stent System (Approval No. 22400BZX00176000)”. To maintain radiopacity, platinum-iridium alloy was used for inner core of the strut. The results of clinical studies conducted in the United States were submitted to evaluate the efficacy and safety in patients with symptomatic ischemic cardiac disease. |
| May 30, 2017 | 4-U CLS Hip ProsthesisTotal hip prosthesis | Teijin Nakashima Medical Co., Ltd. | New device | Not listed | — | 967 days | An acetabular cup and a sleeve to be used exclusively with femoral stem of hip prosthesis to replace or reconstruct the hip joint. Both components can be fixed without bone cement and are manufactured by Electron-beam additive manufacturing using Ti-15Zr-4Nb-4Ta alloy powder. The results of a Japanese clinical study were submitted to evaluate the efficacy of the new surface treatment using GRAPE Technology, which gives bone conductivity to this device. |
| May 26, 2017 | SpaceOAR SystemAbsorbable tissue spacer for radiation therapy | Augmenix, Inc. | New device | Apr 1, 2015 | 26 mo later | 365 days | A synthetic absorbable material intended to be injected and provide space between the prostate and anterior rectal wall, in order to reduce radiation exposure to the rectum during radiation therapy for prostate cancer. The components include an injection syringe and injection needle, etc. The results from a foreign clinical study which compared two groups undergoing Intensity Modulated Radiation Therapy (IMRT) with and without the device were submitted to evaluate the effectiveness in reduction of radiation exposure to the rectum. |
| May 12, 2017 | PRESTIGE LP Cervical Disc SystemTotal Disc Replacement Prothesis | Medtronic Sofamor Danek Co., Ltd. | New device | Jul 24, 2014 | 34 mo later | 347 days | An artificial cervical disc intended to maintain intervertebral mobility by replacing the affected cervical disc with this device after removing factors causing compression, such as herniated nucleus pulposus or osteophytes. The results from a foreign, multi-center, prospective, non-inferiority, controlled study verifying the non-inferiority to the conventional therapy (Anterior Cervical Discectomy and Fusion [ACDF]) in patients who require surgery for cervical degenerative disc disease were submitted to evaluate the efficacy and safety of this device. |
| Mar 29, 2017 | Vagus Nerve Stimulation Device Aspire SRVagus nerve stimulation device with anti-seizure effects | Cyberonics, Inc. | New device | May 29, 2015 | 22 mo later | 300 days | An electrical stimulation device to stimulate vagus nerve as an adjuvant therapy to reduce the frequency of seizures for patients with drug- resistant epilepsy who have refractory epileptic seizures (excluding those responding to craniotomy procedure). This device was developed based on the "Vagus Nerve Stimulation Device VNS System" (Approval No. 22600BZI00008000) and equipped with an additional automatic stimulation mode to automatically deliver electrical stimulation triggered by the sudden increase in heart rate before and after epilepsy seizure. Results from foreign clinical studies were submitted to evaluate the efficacy and safety of the automatic stimulation mode. |
| Mar 27, 2017 | BSC OI Ablation CatheterCardiovascular ablation catheter | Boston Scientific Japan K. K. | New device | Feb 24, 2016 | 13 mo later | 234 days | A catheter for the treatment of arrhythmia. It is designed to be inserted percutaneously to the heart through a blood vessel to apply a radiofrequency current to the target site of arrhythmia identified electrophysiologically, in order to treat persistent or recurrent type I atrial flutter. The improvement from the company's approved product is an irrigation function of this product to deliver saline from the irrigation holes at the electrode tip. Results from foreign clinical studies that evaluated the efficacy and safety of the irrigation function were submitted. |
| Mar 23, 2017 | Prodigy MRI Dual 8 NeurostimulatorImplantable stimulator for pain relief | St. Jude Medical Japan Co., Ltd. | New device | Oct 3, 2016 | 6 mo later | 226 days | An implantable stimulator that generates electrical stimulation and its accessories used in spinal stimulation therapy for patients with chronic refractory pain in the trunk and extremities who are not sufficiently responsive to pain relief therapy with drugs or nerve block. Results of foreign clinical studies using this product were submitted to demonstrate that efficacy and safety of the new stimulation mode not included in conventional products were not inferior to those of the conventional stimulation mode. |
| Mar 21, 2017 | Diamondback 360 Coronary Orbital Atherectomy System Micro CrownAngioplasty catheter for ablation atherectomy | Cardiovascular Systems, Inc. | New device | Mar 19, 2017 | Same month | 264 days | An atherectomy device used to remove calcified plaques in severely calcified lesions of new stenotic lesions caused by coronary arteriosclerosis using high speed rotation of diamond coated crown and diamond coated tip at end of shaft thereby facilitating postoperative coronary intervention. The product controls the eccentricity of the crown by the speed of rotations and therefore can be used for large or small lumen diameter vessels without changing the size of the product in contrast to approved similar products whose size must be changed to the larger size depending on the diameter of the target lumen. The results of non-clinical studies demonstrating the ability of this device to cut calcified plaques in the coronary artery as an atherectomy device and those of foreign clinical studies and Japan-US global clinical trial performed to evaluate the efficacy and safety of the adjuvant therapy for stent placement using the product for severely calcified lesions were submitted. |
| Mar 9, 2017 | ERBE CRYO2Versatile cryosurgical unit | Amco Inc. | New device | May 4, 2015 | 22 mo later | 232 days | A cryosurgery unit used for tissue biopsy or removal of foreign matters by cooling/freezing the bronchus, bronchial peripheral tissue, or foreign matters in the bronchus by touching with the probe tip cooled by high pressure carbon dioxide. It was judged that clinical evaluation was necessary because its indications differ from those of existing cryosurgery equipment. |
| Mar 9, 2017 | Misago 3Stent for blood vessel | Terumo Corporation | New device | Not listed | — | 178 days | A stent system consisting of a self-expanding nickel-titanium alloy stent and a delivery system to deliver the stent to the lesion site, used for the treatment of symptomatic artery diseases with reference vessel diameters of 4-7 mm and target lesion length of 40-150 mm in the superficial femoral artery region by dilatation of the artery and maintenance of the lumen, and for the treatment of acute or impending occlusions associated with unsuccessful intervention treatments in the same lesion. The system uses the same stent as the company's approved product, "Misago" (Approval No. 22400BZX00463000), but differs from the approved product in that its delivery system is specialized in placing the stent to the target lesion by the ipsilateral approach. The results of clinical studies using the original product "Misago" were provided as clinical evaluation material and the rationale for its extrapolation was explained. |
| Mar 3, 2017 | Quadra Assura MPInstrument & apparatus Implantable 7 biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Feb 12, 2016 | 13 mo later | 403 days | An implantable biventricular pacing pulse generator with a defibrillator function (CRT-D) for cardiac resynchronization therapy (CRT). A multi-point pacing (MPP) function of this product allows the user to choose 2 electrodes as the left ventricular pacing positions while similar CRT-Ds can provide only one out of 4 electrodes (hereinafter referred to as BiV pacing). The MPP function is used in patients who do not respond to BiV pacing. Results from a non-clinical study ensuring the required function for CRT and safety in MRI and foreign clinical study evaluating the efficacy and safety of the MPP function were submitted. |
| Feb 23, 2017 | IRIS MonitorHeart rate monitor | Atom Medical Corporation | New device | Not listed | — | 265 days | A heart rate monitor designed to non-invasively measure, display, and save fetal heart rate through the mother's abdomen. Unlike the approved similar medical devices using the ultrasonic or direct induction method, this device detects bioelectric signals via the electrode placed on the mother's abdominal wall and thereby determing the fetal heart rate based on the extracted signals. |
| Feb 17, 2017 | INSPIRIS RESILIA Aortic ValveInstrument & apparatus Bovine pericardial 7 valve | Edwards Lifesciences Limited | New device | Not listed | — | 262 days | A bovine pericardial valve intended to function as a substitute for a malfunctioning cardiac valve. The product structure is based on the approved product "Carpenter-Edwards Bovine Pericardial Biological Valve Magna EASE ThermaFix Process" (Approval No. 22300BZX00320000) and it has a specially-processed leaflet tissue to enhance anticalcification and enable storage without glutaraldehyde solution. The results of US and EU clinical studies were submitted to evaluate the efficacy and safety of this product in patients with aortic valve disease requiring aortic valve replacement. |
| Feb 14, 2017 | Micra Transcatheter Pacing SystemImplantable leadless cardiac pacemaker | Medtronic Japan Co., Ltd. | New device | Apr 6, 2016 | 10 mo later | 365 days | A single-chamber transcatheter implantable cardiac pacemaker designed to periodically deliver artificial electrical impulses to the heart of the patients with bradycardia. Results from global clinical trial including Japan were submitted to evaluate the efficacy and safety of the device in the treatment of bradyarrhythmia. |
| Feb 14, 2017 | Micra IntroducerCardiac catheter introducer kit | Medtronic Japan Co., Ltd. | New device | Sep 27, 2013 | 41 mo later | 365 days | A kit composed of an introducer sheath and dilator used to transdermally insert the treatment or diagnostic device including the "Micra Transcatheter Pacing System" (Approval No. 22900BZX00047000) into a vein. The results of global clinical studies including Japan conducted to evaluate the efficacy and safety when using the Micra Transcatheter Pacing System with this product in the treatment of bradyarrhythmia were submitted. |
| Feb 13, 2017 | Asahi Hollow Fiber Hemodiafilter ABH-PAHemodiafilter | Asahi Kasei Medical Co., Ltd. | New device | Not listed | — | 250 days | A hemodiafilter used to remove fluid and uremic substances stored in the body due to uremia. This device is indicated for patients with extremely impaired renal function caused by chronic or acute kidney failure. The device differs in the composition of hollow fiber polymer from that of the approved "Asahi Hollow Fiber Hemodiafilter" (Approval No. 22200BZX00577000), using a wavy hollow fiber to reduce transmembrane pressure difference during hemodiafiltration. |
| Jan 10, 2017 | Tecnis Symfony VBInstrument & apparatus Multifocal posterior 72 chamber lens | AMO Japan K.K. | New device | Not listed | — | 218 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision in patients with aphakia. The raw material and basic structure of this device are identical to those of the company's approved product, "Tecnis 1-Piece VB" (Approval No. 22400BZX00172000), but with the same diffractive multifocal function as "Tecnis Symfony" (Approval No. 22900BZX00006000) at the posterior optic zone. Results of foreign clinical studies using "Tecnis Symfony" (Approval No. 22900BZX00006000) to evaluate clinical efficacy and fundamental safety, including visual function as a multifocal posterior chamber lens, were submitted, and the rationale for its extrapolation was explained. |
| Jan 10, 2017 | Tecnis SymfonyMultifocal posterior chamber lens | AMO Japan K.K. | New device | Jul 15, 2016 | 6 mo later | 263 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct near, intermediate and far vision in patients with aphakia. The raw material and basic structure of this device are identical to those of the company's approved product "Tecnis Multifocal 1-Piece" (Approval No., 22300BZX00277000), but this device differs in light distribution, focused mainly from far to intermediate distance by improving the diffractive multifocal function such as the number of diffractive rings and step heights. Results of foreign clinical studies using an approved monofocal posterior lens as a control to evaluate the clinical efficacy and fundamental safety, including visual function as a multifocal posterior lens, were submitted. |
| Dec 27, 2016 | TruePath Chronic Total Occlusion (CTO) DeviceOscillating peripheral artery recanalization catheter system | Boston Scientific Japan K.K. | New device | Apr 16, 2014 | 32 mo later | 641 days | The device is used for chronic total occlusion that is difficult to be penetrated with a guidewire during percutaneous transluminal angioplasty. Using mechanical rotation, the device penetrates the lesion to secure the passage for a guidewire. Results of foreign clinical study using this device were submitted to verify the status of penetration through lesions in peripheral vessels and the presence or absence of blood vessel perforation after the procedure. |
| Dec 27, 2016 | Denali IVC FilterInferior vena cava filter | Medicon, Inc. | New device | May 15, 2013 | 43 mo later | 224 days | The device, consisting of an inferior vena cava filter and the delivery system, is used to prevent pulmonary embolism. The device was developed based on the concept of risk reduction for blood vessel penetration, enhancement of resistance to migration and fracture, and secure retrieval of the devices after a long-term implantation, etc., and characterized by addition of an anchor and penetration limiter to the legs and the one-piece body by laser cutting. Data of foreign clinical studies conducted to evaluate the success rates of placement and retrieval of the devices were submitted. |
| Dec 22, 2016 | Smart CuretteUltrasonic surgical instrument | Medical U&A, Inc. | New device | Jan 3, 2007 | 120 mo later | 155 days | The device is an ultrasonic surgical instrument used for wound debridement. It sprays physiological saline from the tipping of the probe and dissects necrotic tissue, etc. by vibrating the probe tip. A clinical evaluation report summarizing results from domestic and foreign clinical studies on the device and similar products was submitted to demonstrate that debridement by ultrasonic surgical instruments is effective in wound therapy. |
| Dec 15, 2016 | Long-Pulsed Alexandrite Laser GentleLase ProAlexandrite laser | Syneron Candela K.K., | New device | Dec 26, 2013 | 36 mo later | 359 days | The device is intended to achieve long-term hair reduction by selective photothermolysis. The device is equipped with a dynamic cooling device, which sprays cryogen to prevent skin damage caused by laser irradiation. A clinical evaluation report, which summarized the results from foreign clinical studies for the previous- generation products, was submitted to evaluate the long-term efficacy of hair reduction and the risk of complications after laser treatment. |
| Dec 15, 2016 | MR Guided Focused Ultrasound Surgery ExAblate 4000Focused Ultrasound System | InSightec Ltd. | New device | Jul 11, 2016 | 5 mo later | 364 days | The device is a focused ultrasound surgery system intended for focally heating and ablating targeted brain tissues by irradiating focused ultrasound to the target in the thalamus from outside the skull. By connecting to an MR device, the device can be used to alleviate essential tremor which does not respond sufficiently to drug therapies. The cell necrosis is induced at the heated temperature of target region by focusing the ultrasound beam emitted from the transducer helmet on the central intermediate nucleus of the thalamus. Results from foreign clinical studies were submitted to evaluate the efficacy and safety of the device in patients with essential tremor who were refractory to drug therapies. |
| Dec 15, 2016 | FlexAbility SE Irrigated CatheterCardiovascular ablation catheter | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 244 days | An ablation catheter intended to treat common atrial flutter, diagnosing arrhythmia by pacing and mapping during percutaneous transluminal myocardial ablation. The device was developed based on "FlexAbility Irrigated Catheter" (Approval No. 22500BZX00096000). The approval application was submitted for the major changes such as additions of a magnetic sensor to acquire position information and an indication for paroxysmal atrial fibrillation, and a change in raw materials. To demonstrate the efficacy and safety of the device in the treatment of paroxysmal atrial fibrillation, data from foreign clinical studies using the devices different from this product was submitted. However, the results of the study could not be extrapolated for the examination of this device. Therefore, paroxysmal atrial fibrillation was removed from the indication. |
| Dec 13, 2016 | Mini-BAL Sampling CatheterBronchoalveolar lavage (BAL) catheter | Halyard Healthcare, Inc. | New device | Jul 30, 1993 | 280 mo later | 300 days | A single-use catheter used to collect specimens by bronchoalveolar lavage (BAL) without bronchoscope to diagnose pneumonia. The device is used in adult patients with an artificial airway created by procedures such as tracheal intubation or tracheotomy. Although the catheter is inserted without visualization, the tip of the catheter is curved so that the catheter can be smoothly inserted into the right and left bronchi. In addition, the area of catheter tip coming in contact with the bronchial wall is round-shaped. A clinical evaluation report based on the information collected from the literatures on the device and the similar products was submitted as the clinical evaluation data. |
| Nov 29, 2016 | CrossBoss Coronary CTO Crossing CatheterCoronary recanalization catheter | Boston Scientific Japan K.K. | New device | May 10, 2011 | 67 mo later | 343 days | A coronary recanalization catheter used to treat coronary chronic total occlusion (CTO) during percutaneous transluminal angioplasty (PTCA). The device is used in the difficult cases to pass the guidewire through the lesion for the purpose of securing the passage. The device may be moved toward the target lesion along the guidewire or precede the guidewire. Results from foreign clinical studies, which confirmed that the guidewire was able to be placed in the true lumen crossing the CTO in patients unsuccessfully treated with the existing guidewire, were submitted. |
| Nov 14, 2016 | HeartFlow FFR CTCirculatory dynamics analysis program | HeartFlow Japan G.K. | New device | Nov 26, 2014 | 24 mo later | 634 days | A diagnosis support program that calculates the fractional flow reserve (FFRCT) by computational fluid dynamics analysis based on the data of coronary computed-tomography angiography in clinically stable patients suspected of having coronary artery diseases. Results from foreign clinical studies were submitted to evaluate the diagnostic performance pertaining to sensitivity and specificity of FFRCT values against FFR values measured with a pressure wire. |
| Nov 8, 2016 | CoreValve Evolut RTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Jun 22, 2015 | 17 mo later | 288 days | A prosthetic cardiac valve system used for transcatheter valve implantation in the native aortic valve for patients with symptomatic severe aortic valve stenosis attributed to sclerosis and degeneration of the cusp of the native valve, for whom surgery cannot be performed. This device has been improved in the diameter of outflow area and the length, etc. from those of the previously approved "CoreValve" (Approval No. 22700BZX00100000), for the purpose of reducing deformation caused by interference with the ascending aorta. In addition, the device includes a 23-mm-diameter size variation, which is not available in "CoreValve" system. Furthermore, the delivery system also has been improved to enhance the safety and allow the valve to be recaptured, repositioned, or retrieved, etc. Results of domestic clinical study were submitted to evaluate the efficacy and safety of the 23-mm-diameter product in Japanese patients, in addition to the results of foreign clinical studies in patients with symptomatic severe aortic valve stenosis whose risks for surgical aortic valve replacement were estimated as "High risk" or "Extreme risk." |
| Nov 2, 2016 | Absorb GT1 Bioresorbable Vascular Scaffold SystemAbsorbable coronary stent | Abbot Vascular Japan Co., Ltd. | New device | Jul 5, 2016 | 4 mo later | 552 days | A stent system consisting of an everolimus- eluting bioresorbable scaffold used for the treatment of patients with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length ≤24 mm) with a reference vessel diameter ranged from ≥2.5 mm to ≤3.75 mm, and a delivery catheter to place the stent at the site of stenosis. Results of domestic and foreign clinical studies using the previous generation model of the device were attached to show that the efficacy and safety of the device are equivalent to those of the previously approved coronary stent. |
| Nov 2, 2016 | DURAWAVESynthetic artificial dura mater | GUNZE LIMITED | New device | Not listed | — | 267 days | The device is an artificial dura mater, primarily composed of polyglycolic acid, and identical to the previously approved product "NEOVEIL" (Approval No. 20400BZZ00322000). This application was submitted to newly obtain the indication of prosthetic dura mater, which is listed as a contraindication in the package insert for the already approved product. With the use of biological tissue adhesive, suturing is not necessary and the functioning as a prosthesis for dura mater deficit is easily and successfully achieved. Clinical study results on the device examining the sealing capability as well as effectiveness in prevention of cerebrospinal fluid leakage and subcutaneous cerebrospinal fluid retention were submitted. |
| Oct 27, 2016 | TactiCath Quartz Ablation SystemCardiovascular ablation catheter | St. Jude Medical Japan Co., Ltd. | New device | Oct 24, 2014 | 24 mo later | 706 days | A device consisting of an electrode catheter and the dedicated system components. The device system is intended to treat drug treatment resistant, symptomatic paroxysmal atrial fibrillation and common atrial flutter, and is capable of percutaneous transluminal myocardial ablation with a high-frequency current as well as cardiac electrophysiological study. The device also allows real-time monitoring of the contact force. Data related to foreign clinical study were submitted to show the efficacy and safety of the device used in the treatment of paroxysmal atrial fibrillation. |
| Oct 27, 2016 | TactiCath Quartz Ablation System NCardiovascular ablation catheter | St. Jude Medical Japan Co., Ltd. | New device | Oct 24, 2014 | 24 mo later | 80 days | A device consisting of an electrode catheter and the dedicated system components. The device system is intended to treat drug treatment resistant, symptomatic paroxysmal atrial fibrillation and common atrial flutter, and is capable of percutaneous transluminal myocardial ablation with a high-frequency current as well as cardiac electrophysiological study. This device was developed based on the approved "TactiCath Quartz Ablation System" (Approval No. 22800BZX00394000), with modifications of the adhesive at the tip of the catheter and image sensor. Data related to foreign clinical study were submitted to show the efficacy and safety of the device used in the treatment of paroxysmal atrial fibrillation. |
| Oct 25, 2016 | Neuraceq Automated Synthesizer SyntheraRadiopharmaceutic al synthesizer | SCETI K.K. | New device | Not listed | — | 848 days | A radioactive pharmaceutical synthesizer used for the semi-automated preparation of a 18 radioisotope labeled compound, florbetaben ( F) injection, by remote control system indicated for the visualization of beta-amyloid plaques in the brain of patients with cognitive impairment suspected to be Alzheimer's disease. Results from non-clinical and global clinical studies were submitted as evaluation data on the efficacy and safety of this product and 18 florbetaben ( F) injection. |
| Oct 25, 2016 | DARTS Wrist ProsthesisTotal wrist prosthesis | Teijin Nakashima Medical Co., Ltd. | New device | Not listed | — | 512 days | A total wrist prosthesis that functions as a substitute of a natural wrist, by replacing a severely destroyed and impaired wrist due to underlying diseases such as rheumatoid arthritis, etc. The improvement of joint function and elimination of pain can be expected by replacing the dysfunctional wrist with the device. The device is designed as a semi-constrained surface replacement type, in order to closely mimic the natural joint surface shapes, forming a structure that induces dart thrower's motion, which is more natural physiological motion of the wrist. Results from an investigator-initiated clinical study conducted in Japan were submitted to evaluate the efficacy and safety of the device. |
| Oct 25, 2016 | Stingray SystemCoronary recanalization catheter | Boston Scientific Japan K.K. | New device | Dec 4, 2015 | 11 mo later | 403 days | A coronary recanalization catheter used to treat coronary chronic total occlusion (CTO) during percutaneous transluminal coronary angioplasty (PTCA). The device is used in the difficult cases to pass the guidewire through a lesion, assisting the guidewire inserted into the subintimal space to re-enter into the true lumen and securing the passage. The catheter and the guidewire with a projected tip allow the guidewire to re-enter into the true lumen. Results from foreign clinical studies, which confirmed that the guidewire of this system was able to be placed in the true lumen crossing the CTO in patients unsuccessfully treated with the existing guidewire, were submitted. |
| Oct 19, 2016 | Titanium Elastic Nail (Sterilized)Intramedullary nail for internal fixation of femoral fracture | Johnson & Johnson K.K. | New device | Jul 18, 1997 | 231 mo later | 807 days | An intramedullary nail made of titanium alloy used for fracture fixation of the femur, tibia, humerus, radius, and ulna in pediatric patients, and the humerus, radius, and ulna in adult patients. The nailing system is used for the elastic stable intramedullary nailing technique, which allows fixation in the medullary cavity without damaging the epiphyseal line, for diaphyseal fractures in pediatric patients. A clinical evaluation report summarizing foreign clinical study results on the device was submitted to verify that fracture healing can be achieved without any serious complication. |
| Oct 14, 2016 | Toraylight HDFHemodiafilter | Toray Medical Co., Ltd. | New device | Not listed | — | 198 days | A hemodiafilter used to remove fluid and uremic substances stored in the body due to uremia in patients with extremely impaired renal function caused by chronic or acute kidney failure. Based on the previously approved "Toraylight NV" (Approval No. 22200BZX00871000), a light-weight, hollow-fiber dialyzer without filling fluid, this device was developed to improve the operability in hemodiafiltration with increased surface area of the membrane. Results from a domestic clinical study were submitted to evaluate safety and efficacy of the device, in accordance with the PFSB Notification No. 0301-5 dated March 1, 2013. |
| Sep 27, 2016 | Impella Circulatory Assist Pump CatheterImplantable Pump Catheter for Ventricular Support | Abiomed, Inc. | New device | May 30, 2008 | 100 mo later | 2007 days | The catheter-based blood pump that assists systemic circulation in patients with drug resistant acute heart failure, such as cardiogenic shock, can be inserted through femoral artery and placed in the left ventricle. This device pulls blood directly from the left ventricle and expels the blood from the catheter into the ascending aorta. The catheter pump, (two models are available: Impella 2.5 and Impella 5.0), is a catheter based blood pump equipped with a small axial flow pump. The blood is unloaded from an inlet placed in the left ventricle and pumped to an outlet placed in the aorta by the pump-unit of the catheter pump. The device is used with "Impella Controller" (Approval No. 22800BZI00031000). Data from a foreign clinical studies, which demonstrated that using the device is beneficial in patients with cardiogenic shock or other acute heart failure, were submitted. |
| Sep 27, 2016 | Impella ControllerController of Implantable Pump Catheter for Ventricular Support | Abiomed, Inc. | New device | Jul 8, 2010 | 75 mo later | 2007 days | The device is an extermal controller for "Impella Circulatry Assist Pump Catheter" (Approval No. 22800BZI00032000) (hereinafter referred to the Catheter Pump). The device controls the performance and monitors the catheter position of the Catheter Pump, and controls the flow rate of the purge cassette, which is a component of the Catheter Pump. Data from foreign clinical studies, which demonstrated that this device is capable of controlling the Catheter Pump when used for circulatory support in patients with cardiogenic shock or other acute heart failure, were submitted. |
| Sep 9, 2016 | Juvederm Vista Voluma XCInjectable material to a soft tissue using hyaluronic acid | Allergan Japan K.K. | New device | Oct 22, 2013 | 35 mo later | 260 days | An injectable material to soft-tissue using hyaluronic acid injected into a subcutaneous or a supraperiosteal deep tissue to correct volume loss in the midface, chin or temple in adults. The product contains 0.3 wt% of lidocaine hydrochloride to alleviate pain at the time of injection. Results from foreign clinical studies were submitted to evaluate the effect of volume correction in the midface. |
| Aug 22, 2016 | Kodama CatheterCentral circulation system intravascular ultrasound catheter | ACIST Medical Systems | New device | Dec 17, 2011 | 56 mo later | 280 days | An intravascular ultrasound catheter for imaging of the vascular lumen and wall of the central circulatory system using ultrasound. The device is connected to the previously certified device "HD-IVUS System" (Certification No. 226ADBZX00178000) to irradiate the observation target site with ultrasonic wave from the sensor in the tip, and display images by processing the reflected signals. Majority of approved intravascular ultrasound catheters can be set at 40 MHz of ultrasonic frequency only; in contrast, the device can be set at either 40 or 60 MHz to improve the distance resolution and azimuth resolution. A clinical evaluation report summarizing foreign clinical studies was submitted to evaluate the ability to distinguish vascular lesions. |
| Aug 4, 2016 | RenerveCollagen-using absorbent nerve regeneration- inducing material | Nipro Corporation | New device | Not listed | — | 478 days | An absorbent nerve regeneration-inducing material which is to be placed into the torn or deficit part of peripheral nerve, except the inside of dura mater, to induce neurotization. Pig skin collagen is used as a raw material. Japanese clinical study results were submitted to evaluate the recovery rate of sensory function after treatment with the product. |
| Jun 24, 2016 | Thermocool Smarttouch SFCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Aug 11, 2016 | 2 mo earlier | 84 days | An ablation catheter to be used for conducting cardiac ablation with high-frequency current and cardiac electrophysiologic technique for the treatment of patients with drug refractory symptomatic paroxysmal or persistent atrial fibrillation, atrial flutter, and patients with ventricular tachycardia who have not responded to other therapies. This product is an ablation catheter with the irrigation function of "Navistar Thermocool SF" (Approved No. 22300BZX00453000) with additional contact force-sensing function of the "Thermocool Smarttouch" (Approval No. 22400BZX00163000). The results of SMART- AF study, conducted outside Japan were submitted as clinical evaluation data, in order to demonstrate the safety and efficacy of "Thermocool Smarttouch," as an irrigation catheter with contact force-sensing function, in the treatment of patients with drug refractory symptomatic paroxysmal atrial fibrillation. |
| Jun 21, 2016 | AdSprayBioresorbable adhesion barrier | Terumo Corporation | New device | Not listed | — | 365 days | An adhesion barrier applied to the surgical wound to prevent surgical adhesions after surgery of abdomen or pelvic cavity. A spray style was adopted to improve the workability and to enable the use in areas of complex structures. When sprayed, gel is formed in the applied area and works as a physical barrier to prevent adhesion. The results of a pharmacokinetics study in humans demonstrate that gel remains for about 24 hours, and subsequently undergoes breakdown and absorption. Results from a Japanese clinical trial were submitted, in which the product was applied right under a midline incision following laparoscopic surgery, to evaluate the product's effects to reduce the incidence rate, size, and the severity of adhesion. |
| Jun 13, 2016 | Freestyle Libre ProGlucose monitoring system | Abbott Japan Co., Ltd. | New device | Not listed | — | 570 days | A glucose monitoring system for professional use to continuously measure and record glucose levels in the interstitial fluid. When the healthcare professional scans the Reader over the sensor, the fluctuation patterns of the interstitial fluid glucose level are displayed on the screen. Results from clinical studies were submitted to compare the correlation between glucose level in blood or plasma and that in the interstitial fluid in order to evaluate the accuracy of the interstitial glucose levels measured by the product and the safety. |
| Jun 13, 2016 | Bausch + Lomb AqualoxReusable colored contact lenses for correcting visual acuity | B.L.J. Company, Ltd. | New device | Sep 11, 2013 | 33 mo later | 593 days | Reusable tint-colored contact lenses with vision correction which may be worn whole day for maximum two weeks. The lens is made of samfilcon A, a silicone hydrogel material with a water content of 46% and an oxygen permeability (Dk) of 114. Because of the novelty in the raw materials, a clinical study was conducted to confirm the efficacy and safety in wearing the lenses to correct visual acuity. |
| May 31, 2016 | Lifestent Solo Vascular Stent SystemStent for blood vessel | Medicon, Inc. | New device | Feb 13, 2009 | 88 mo later | 407 days | A self-expanding vascular stent used for the treatment of symptomatic arterial disease with a lesion length up to 200 mm in the region from native superficial femoral artery (SFA) to proximal popliteal artery with reference vessel diameter of 4.0-6.5mm, and for the treatment of acute or impending occlusion in the aforementioned sites following the failure of interventional treatment. The following data was submitted: results from the foreign pivotal study to evaluate the performance of the product in lesion lengths up to 150 mm and a domestic study conducted to investigate whether the data can be extrapolated to Japanese population; a clinical evaluation report compiling the data from a foreign clinical study conducted to evaluate the performance of the product in lesion lengths up to 200 mm and literature reports on the results of surgical and endovascular treatments for lesions up to 200 mm in length. |
| May 25, 2016 | Freestyle LibreGlucose monitoring system | Abbott Japan Co., Ltd. | New device | Not listed | — | 614 days | A glucose monitoring system to continuously measure and record glucose levels in the interstitial fluid. When the user scans the Reader over the sensor, fluctuation patterns of the interstitial fluid glucose level are displayed on the screen. In addition, the Reader also has the function of measuring blood glucose and blood ketone levels, as a glucose meter for self- testing. Results from clinical studies were submitted to compare the correlation between glucose level in blood or plasma and that in the interstitial fluid in order to evaluate the accuracy of the interstitial glucose levels measured by the product and the safety. |
| May 25, 2016 | Sorbact Foam DressingSecondary foam dressing for wound healing | ABIGO Medical AB | New device | Not listed | — | 299 days | A secondary foam dressing for wound healing to be used for wounds reaching subcutaneous adipose tissue (excluding third-degree burns) to protect wounds, maintain a moist wound environment, accelerate curing, and alleviate pain. The following improvement is made in the product: cellulose acetate fabric, which was made hydrophobic-by a covalent bond with dialkyl carbamoyl chloride (DACC), is used in the product surface coming into contact with the wound. |
| May 9, 2016 | KMC Kyphoplasty SystemSingle-use vertebral body restoration device | Nihon Americare Co.,Ltd. | New device | Sep 17, 2012 | 44 mo later | 1075 days | A single-use device used in balloon kyphoplasty (BKP) for restoration of fractured vertebral body. The system is used to create a cavity in the fractured vertebral body for patients in acute phase of compression fracture in one vertebral body due to primary osteoporosis, whose pain has not relieved after receiving sufficient conservative treatment. Improvements are made to enable: restoration of vertebral height using an expandable balloon; and reduction of the risk of cement leakage outside the vertebral body by creating a cavity for bone cement injection. |
| May 9, 2016 | Mendec Spine Bone Cement KitOrthopedic bone cement | Nihon Americare Co.,Ltd. | New device | Jun 9, 2005 | 131 mo later | 1075 days | Orthopedic bone cement for percutaneous vertebroplasty (PVP) in patients with vertebral fracture accompanying pain due to malignant vertebral tumor, or balloon kyphoplasty (BKP) in patients in acute phase of compression fracture in one vertebral body due to primary osteoporosis. Following improvements are made: enhancement of the visibility under fluoroscopy by increasing the amount of barium sulfate; and extension of the curing time as compared with that of the approved product, "KYPHON BKP Bone Cement HV-R" (Approval No. 22200BZX00119000) in order to enhance its operability. |
| Apr 25, 2016 | Paragon Ortho-KOrthokeratology contact lens | Eyemed Co., Ltd. | New device | Jun 13, 2002 | 166 mo later | 1060 days | Orthokeratology contact lens with a specially shaped inner surface intended to reshape the corneal surface by wearing it during sleep and to correct and maintain the unaided vision during daytime after removal of the lens. A domestic clinical study was conducted to evaluate the efficacy such as how precisely the eyesight is corrected, etc. and the safety such as harm to the cornea, etc. |
| Mar 30, 2016 | SmartSet GMV Endurance Gentamicin Bone CementOrthopedic Bone Cement | Johnson & Johnson K.K. | New device | Feb 5, 2004 | 146 mo later | 496 days | This product is orthopedic bone cement containing gentamicin sulfate as antibiotic, and is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. A clinical evaluation report was submitted to demonstrate that a necessary fixation can be obtained, and the safety of the device is equivalent to that of bone cements without antibiotics. |
| Mar 30, 2016 | Chest Tomosynthesis CAD: Cadviser TSDiagnostic x-ray imaging system workstation | Shimadzu Corporation | New device | Not listed | — | 581 days | An X-ray diagnostic imaging workstation intended to provide imaging information for diagnosis, which is the computer-processed image data of the lung field from thoracic tomosynthesis images produced using an X-ray fluoroscopy system or an X-ray diagnostic system. The device has the computer-aided detection (CAD) functions, in which potential pulmonary nodules are extracted and the information is provided to prevent misdiagnosis that the nodules are overlooked by radiologists. This CAD function is intended to assist in reading images by radiologists, but not to perform screening or definitive diagnosis of lung cancer based only on the results provided by the device. Domestic clinical study results were submitted to evaluate the clinical diagnostic ability of the CAD function. |
| Mar 28, 2016 | enLIGHTenNeodymium:YAG laser | Cutera K.K. | New device | Aug 11, 2014 | 20 mo later | 396 days | Q-switched neodymium (Nd): YAG laser used for the vaporization and removal of benign pigmented lesions on the body surface. The pulse width can be set at 750 psec or 2 nsec, allowing the treatment with high peak powers. Foreign clinical study results were submitted to evaluate the risk of complications or adverse events associated with an increase in peak power. |
| Mar 25, 2016 | iStent Trabecular Micro-Bypass Stent SystemHeparin using intraocular drain | Glaukos Corporation | New device | Jun 25, 2012 | 45 mo later | 564 days | A device consisting of the iStent, a titanium-alloy glaucoma implant designed to maintain patency of an outflow canal passing through the trabecular meshwork so that aqueous humor drains from the anterior chamber into Schlemm's canal and is directed naturally to the normal outflow canal, and its inserter. The surface of the iStent is coated with porcine- derived heparin. Results from foreign clinical studies were submitted to evaluate the efficacy and safety of the device in patients with mild-to-moderate glaucoma requiring cataract surgery, for whom the device is indicated. |
| Mar 11, 2016 | Edwards Sapien 3Transcatheter bovine pericardial valve | Edwards Lifesciences Limited | New device | Jun 17, 2015 | 9 mo later | 301 days | A prosthetic heart valve system used for transcatheter valve implantation for patients with severe symptomatic aortic valve stenosis and for whom surgical aortic valve replacement cannot be performed due to their general condition and comorbidities. Foreign clinical study results were submitted to demonstrate that the efficacy and safety of the new device are equivalent to those of the existing approved model, Sapien XT. (The original product is in a reexamination period) |
| Mar 11, 2016 | P (LA/CL) SutureSynthetic absorbable suture | Kono Seisakusho Co., Ltd. | New device | Not listed | — | 268 days | Synthetic monofilament absorbable sutures prepared from lactide-caprolactone copolymer fibers. New raw materials were used to improve the suture workability. Therefore, domestic clinical study results were attached to evaluate the efficacy and safety of the device in procedures such as suturing, anastomosis, and ligation in general surgery. |
| Mar 9, 2016 | Lima Delta Ceramic LinersArtificial hip joint, acetabular component | Lima Japan K.K. | New device | Not listed | — | 217 days | The device is an acetabular component for a hip prosthesis made of the material "Biolox delta" (manufactured by CeramTec) and is used in combination with the approved Lima's device, "Lima Delta Ceramic Head" (Approval No. 22500BZX00311000), which is made of the same material as the new device. Given that this is the Lima's first liner made of Biolox delta and the novelty exists in the combination of raw materials, a clinical evaluation report based on the post- market performance outside Japan was submitted to confirm the equivalent efficacy and safety of the new combination to those of the conventional combination using different materials. |
| Feb 24, 2016 | Ceralas HPD LaserDiode laser | Integral Corporation | New device | Sep 15, 2010 | 65 mo later | 462 days | A diode laser with a central wavelength of 980 nm (continuous wave) used in laser vaporization for benign prostatic hyperplasia. The device differs from existing approved medical devices indicated for benign prostatic hyperplasia in that the use of continuous wave laser with a wavelength of 980 nm and the maximum output power 300 W emitted from the oscillator. Domestic clinical study results were submitted to evaluate the efficacy and safety of the device in the treatment of benign prostatic hyperplasia. |
| Feb 15, 2016 | Suncon Kyoto-CSLimbal-supported contact lens for abnormal corneal shape | Sun Contact Lens Co., Ltd. | New device | Not listed | — | 228 days | A limbal-supported, rigid contact lens for patients with ocular sequelae of Stevens- Johnson syndrome or toxic epidermal necrolysis, to alleviate symptoms associated with severe dry eye, etc. as well as to correct visual acuity. An investigator-initiated clinical trial was conducted in Japan to evaluate the efficacy and safety of the product in patients with ocular sequelae for whom the product is indicated. [Orphan device] |
| Feb 15, 2016 | Gore Viabahn Stent GraftHeparin-coated stent-graft for central circulatory system | W. L. Gore & Associates, Co., Ltd. | New device | Jun 14, 2005 | 128 mo later | 257 days | A stent graft system consisting of a stent graft and delivery catheter, used for the treatment for arterial injury in the chest, abdomen, or pelvis, or for maintenance of arterial patency of the superficial femoral artery. A clinical evaluation report and results of the domestic clinical study were submitted to evaluate the efficacy and safety of the device in vascular injury treatment, and vascular patency treatment, respectively. [Priority review product] |
| Feb 15, 2016 | Quattro ・ ICY IVTM CatheterCentral venous placement temperature management system | ZOLL Circulation, Inc. | New device | Not listed | — | 452 days | A central venous catheter with a balloon for heat exchange used for body temperature management (temperature management therapy) in patients under cardiac arrest or after return of (spontaneous) circulation. The catheter is designed to be connected to the console of the approved "Thermogard System" (Approval No. 22400BZI00010000). Temperature-controlled physiological saline circulates within the balloon of the central venous catheter, which allows heat exchange between the balloon surface and the blood in contact with the surface, thereby controlling the temperature of the whole body. A clinical study was conducted in Japan in patients who are under cardiac arrest suspected to be caused by intrinsic cardiac dysfunction or who are after return of (spontaneous) circulation, to evaluate whether body temperature of these patients can be managed appropriately enabling therapeutic hypothermia, and to evaluate the safety. |
| Feb 8, 2016 | Innova Vascular StentStent for blood vessel | Boston Scientific Japan K.K. | New device | Jul 21, 2015 | 7 mo later | 326 days | A self-expanding vascular stent used for the treatment of symptomatic vascular disease in superficial femoral artery or proximal popliteal artery, with reference vessel diameters from 4 mm to 7 mm, lesion lengths up to 150 mm on each limb, and for treatment of acute or impending occlusion in the aforementioned sites following the failure of interventional treatment. Results from global clinical trial were submitted to evaluate the efficacy and safety of the device in the treatment of symptomatic vascular diseases. |
| Jan 12, 2016 | AtriCure Left Atrial Appendage ClipClip for cardiac tissue | Century Medical, Inc. | New device | Jun 10, 2010 | 67 mo later | 817 days | A device used to occlude the left atrial appendage in patients with a risk of thromboembolism including atrial fibrillation and other conditions during an open-heart cardiovascular surgery. Results from foreign clinical studies conducted to evaluate the efficacy and safety of the device were submitted. |
| Jan 5, 2016 | Revive SE Thrombectomy deviceEmboli-removal catheter in the central circulatory system | Johnson & Johnson K.K. | New device | Not listed | — | 292 days | An emboli-removal catheter in the central circulatory system to restore blood flow by removing clots from blood vessels in the brain in patients in the acute phase of cerebral infarction (in principle, within 8 hours from the onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed to restore blood flow with intravenous t-PA therapy. Results from a single-arm clinical study conducted in Japan to confirm that the efficacy and safety of the device is practically equivalent to those of the approved medical device "Merci Retriever (Approval No. 22200BZX00596000) were submitted. (The original product is in a reexamination period) |
| Dec 25, 2015 | Straumann Implant (Roxolid SLActive) TLDental implant body | Straumann Japan K.K. | New device | Feb 26, 2009 | 82 mo later | 540 days | A tissue level dental implant, which is partially or wholly placed into the jawbone. The device has the identical shape and surface treatment to the previously approved device “Straumann Implant (SLActive) TL” (Approval No. 22600BZX00016000). The point of improvement is that the device adopts a titanium alloy with zirconium as a raw material to improve strength. Results from foreign clinical studies were submitted for the evaluation of the efficacy and safety of this raw material. |
| Dec 9, 2015 | AFX Stent Graft SystemAortic stent graft | Cosmotec Co., Ltd. | New device | May 6, 2011 | 55 mo later | 412 days | AFX Stent Graft System consists of a stent graft and delivery system for the endovascular treatment of infrarenal abdominal aortic aneurysms. The device has the basic structure of the company's own approved product “Powerlink Stent Graft System” (Approval No. 22000BZX00110000) (hereinafter referred to as “Powerlink”) with thinner outer diameter of the delivery catheter achieved by thinning the graft material. The indications for this device are the same as those for the Powerlink. In addition, a suprarenal cuff extension, which was not included in the Powerlink, was added as a component. Results from foreign clinical studies were submitted for the evaluation of the efficacy and safety of the cuff extension. |
| Dec 9, 2015 | Kaneka Bare Metal Stent CO-R1Coronary stent | Kaneka Corporation | New device | Not listed | — | 230 days | A coronary stent used for the treatment (including treatment of acute or impending occlusion associated with failure of intervention therapy) of patients with symptomatic ischemic heart disease who have a new or recurrent coronary lesion (a lesion length of 28 mm or less) with a reference vessel diameter of 3.0-4.0 mm. Results from domestic clinical studies were submitted for evaluation of the efficacy and safety of this device. |
| Dec 2, 2015 | Biohesive Ag LightAntibacterial wound dressing and protecting material | Alcare Co., Ltd. | New device | Not listed | — | 383 days | A hydrocolloid dressing containing silver sulfadiazine in anticipation of an antibacterial effect. The device is intended to be used for wounds reaching into dermis, which is the limited-use purpose of the company's own approved antibacterial wound dressing and protecting material “Biohesive Ag” (Approval No. 22300BZX00001000). Results from clinical studies previously submitted for application of the above approved product and data on those results with new analyzation using a stratified analysis were submitted to confirm the efficacy and safety of this product in wounds reaching into dermis. |
| Nov 27, 2015 | Synergy Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Oct 2, 2015 | 2 mo later | 245 days | A stent system consisting of an everolimus-eluting stent used for the treatment of patients with symptomatic ischemic heart disease who have a new coronary lesion (a lesion length of 34 mm or less) with a reference vessel diameter of 2.25-4.00 mm and a delivery catheter used to implant a stent at the site of stenosis. Results from domestic and foreign clinical studies with the use of previous products were attached to demonstrate that this device has efficacy and safety equivalent to those of the approved coronary stents. |
| Nov 25, 2015 | HAL For Medical Use (Lower Limb Type)Biosignal- responsive motor function improvement device | CYBERDYNE Inc. | New device | Not listed | — | 245 days | The device is composed of components that are to be attached to a patient, including a base component, battery pack, upper and lower leg cuff, and sensor shoes, and is used to improve walking function in patients with impaired ambulation caused by slowly progressive neurologic or muscular disease (spinal muscular atrophy, spinobulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie- Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, muscular dystrophy). Results from a domestic clinical trial (an investigator-initiated clinical trial) conducted to confirm the safety and effect in the improvement of walking function were submitted. [Orphan device] |
| Nov 24, 2015 | Electrohydraulic Lithotripter Lithotron EL 27Intracorporeal electrohydraulic shock wave lithotripter | Century Medical, Inc. | New device | Not listed | — | 378 days | An intracorporeal electrohydraulic shock wave lithotripter that crushes gallstones using shock waves generated by a high-voltage discharge between electrodes exposed at the tip of probe. Test results on electrical safety, electromagnetic compatibility, biological safety, stability, durability, and performance of this device were submitted. In addition, clinical results on electrohydraulic shock wave lithotripsy (hereinafter referred to as “EHL”) of this device for gallstones were evaluated. A clinical evaluation report was submitted to compare the treatment outcomes of EHL for gallstones between by this device and by other devices employing the same principle as this device (including the approved devices). |
| Nov 18, 2015 | SATAKE・HotBalloon CatheterCardiovascular ablation catheter | Toray Industries, Inc. | New device | Not listed | — | 357 days | A balloon ablation catheter utilizing a high- frequency current to treat drug-resistant recurrent symptomatic paroxysmal atrial fibrillation. Results from domestic clinical studies using the previous product as an investigational device were submitted to verify the efficacy and safety in patients with drug-resistant symptomatic paroxysmal atrial fibrillation in comparison with control groups receiving antiarrhythmic drugs. |
| Nov 18, 2015 | SATAKE・HotBalloon GeneratorElectronic surgical unit for percutaneous ablation | Toray Industries, Inc. | New device | Not listed | — | 357 days | A high-frequency generator used for percutaneous catheter ablation to treat tachyarrhythmia. The device was developed as a high-frequency generator used exclusively with the “SATAKE HotBalloon Catheter” (Approval No. 22700BZX00355000). Results from domestic clinical studies using the previous product as an investigational device were submitted to verify the efficacy and safety in patients with drug-resistant symptomatic paroxysmal atrial fibrillation in comparison with control groups receiving antiarrhythmic drugs. |
| Nov 6, 2015 | Accolade MRISingle-use extracorporeal assistant artificial cardiac pump | Boston Scientific Japan K.K. | New device | Not listed | — | 329 days | An implantable cardiac pacemaker used to treat bradycardia. Patients implanted with the device can have an MRI scan only when the condition meets imaging criteria. A clinical evaluation report was submitted to demonstrate the safety of this device in MRI scans. In addition, results from foreign clinical studies were submitted for evaluation of the efficacy and safety of a function that automatically regulates the pulse amplitude in atrial pacing. |
| Nov 6, 2015 | Ingevity AFxEndocardial implantable pacemaker lead | Boston Scientific Japan K.K. | New device | Not listed | — | 329 days | A pacemaker lead used when connected to an implantable cardiac pacemaker, etc. Patients implanted with the device can have an MRI scan only when the condition meets imaging criteria. A clinical evaluation report summarizing the clinical data on the product in foreign countries was submitted for the evaluation of the safety of this device in MRI scans. |
| Nov 6, 2015 | IngevityEndocardial implantable pacemaker lead | Boston Scientific Japan K.K. | New device | Not listed | — | 329 days | A pacemaker lead used when connected to an implantable cardiac pacemaker, etc. Patients implanted with the device can have an MRI scan only when the condition meets imaging criteria. A clinical evaluation report summarizing the clinical data on the product in foreign countries was submitted for the evaluation of the safety of this device in MRI scans. |
| Oct 28, 2015 | MyDaySingle-use colored contact lenses for correcting visual acuity | CooperVision Japan, Inc. | New device | Aug 30, 2013 | 26 mo later | 188 days | Daily wear, single-use, colored contact lenses for correction of visual acuity. The lens is composed of stenfilcon A, a silicone hydrogel material with a water content of 54% and an oxygen permeability (Dk) of 80, and is wholly colored in pale blue, containing ultraviolet absorber. Novelty was recognized in the raw material. Results from single-arm, open-label, clinical studies conducted in Japan were submitted to confirm efficacy and safety in wearing the lenses to correct visual acuity. |
| Oct 22, 2015 | LSO1470 LaserDiode laser | Medico's Hirata Inc. | New device | Not listed | — | 269 days | A laser surgical device for treatment of varicose veins of lower extremities by guiding the laser light oscillated from semiconductor laser element into a fiber and irradiating a vein of lower extremities to occlude the saphenous vein. The wavelength of the laser is 1470 nm. In order to verify the efficacy and safety of the product, a single-arm clinical study was conducted to compare the clinical study results of the approved product of 980 nm “ELVeS Laser” (Approval No. 22200BZX00660000). |
| Oct 19, 2015 | Day Menicon PremiOSingle-use colored contact lenses for correcting visual acuity | Menicon Co., Ltd. | New device | Not listed | — | 263 days | Daily wear, single-use, colored contact lenses for correction of visual acuity. The lens is composed of silicone hydrogel with a water content of 56% and an oxygen permeability (Dk) of 64, and is wholly colored in pale blue, containing ultraviolet absorber. Plasma treatment on the surface of the lens improves the wetness of the lens surface at the time of wearing. Novelty was recognized in the raw material. Results from single-arm, open-label, clinical studies conducted in Japan were submitted to confirm efficacy and safety in wearing the lenses to correct visual acuity. |
| Oct 19, 2015 | Solo Stentless Biological ValveBovine pericardial valve | Sorin Group Italia S.r.l. | New device | Jun 24, 2014 | 16 mo later | 174 days | A stentless biological valve made of bovine pericardial membrane to replace the malfunctioning aortic valve due to disease or injury. The device is designed to be implanted in the supra annular position with a single suture line, which was impossible with conventional stentless biological valves. Results from foreign clinical studies conducted based on ISO 5840 were submitted for the evaluation of the efficacy and safety of this product. |
| Sep 28, 2015 | Radiopharmaceutical Synthesis Device MPS200AβRadiopharmaceutic al synthesizer | Sumitomo Heavy Industries, Ltd. | New device | Not listed | — | 546 days | Radiopharmaceutical Synthesis Device used for the semi-automated preparation of a radioisotope 18 labeled compound, florbetapir ( F) injection, by a remote control system indicated for the visualization of beta-amyloid plaque in the brains in patients with cognitive impairment who are suspected of having Alzheimer's disease. Results from non-clinical studies, and domestic and foreign clinical studies were submitted as evaluation data on the efficacy and safety of this 18 product and florbetapir ( F) injection. |
| Sep 18, 2015 | Cook Spectrum M/R Impregnated Central Venous Catheter KitAntimicrobial central venous catheter introducer kit | Cook Japan Inc. | New device | Feb 20, 2007 | 103 mo later | 779 days | This product is a central venous catheter impregnated with minocycline and rifampin to reduce catheter-related bloodstream infections (CRBSIs). A clinical evaluation report was submitted to evaluate the effectiveness in reducing CRBSI and the safety of the device. |
| Sep 17, 2015 | AG-PROTEX HIP SystemTotal hip prosthesis | KYOCERA Medical Corporation | New device | Not listed | — | 269 days | A product containing a small amount of silver in the hydroxyapatite coating of the company’s own approved acetabular cup, “SQRUM HA Shell” (Approval No. 22500BZX00152000) and femur stem “ KYOCERA PerFix HA Stem Fullcoat” (Approval No. 22100BZX01118000), in anticipation of an antibacterial effect. Results from a domestic clinical study were submitted to confirm that the device has equivalent efficacy to the approved hip prosthesis and that no serious malfunction occurs. |
| Sep 16, 2015 | Air Optix ColorsReusable colored contact lenses for correcting visual acuity | Alcon Japan Ltd. | New device | Jan 29, 2014 | 20 mo later | 266 days | Daily wear, two-week replacement, reusable colored contact lenses with vision correction, and reusable colored contact lenses without vision correction. These contact lenses have additional feature of colored ring-shaped regions to the previously approved two-week replacement, silicone hydrogel contact lenses, “Air Optix (22000BZX00109000)”. Novelty was recognized in clear coat which directly contacts with the cornea. Results from multicenter, randomized, open clinical studies conducted in the United States were submitted to confirm efficacy and safety in wearing the lenses to correct visual acuity. |
| Sep 16, 2015 | Air Optix BrightReusable colored contact lenses for correcting visual acuity | Alcon Japan Ltd. | New device | Jan 29, 2014 | 20 mo later | 266 days | Daily wear, two-week replacement, reusable colored contact lenses with vision correction, and reusable colored contact lenses without vision correction. These contact lenses have additional feature of colored ring-shaped regions to the previously approved two-week replacement, silicone hydrogel contact lens “Air Optix (22000BZX00109000)”. The application was submitted for obtaining multiple brand names for “Air Optix Colors.” |
| Sep 14, 2015 | Aequalis Reversed CementlessHumeral component for shoulder prosthesis | Tornier S.A.S. | New device | Jun 5, 2010 | 63 mo later | 297 days | The humeral component of a reverse shoulder prosthesis used in cases of rotator cuff dysfunction such as rotator cuff tear arthropathy or massive rotator cuff tear. The component includes a stem and a metaphysis of which surfaces are treated of grit blasting and plasma spraying of hydroxylapatite, allowing cementless fixation. The device is used in combination with the components of the company's own approved product, “Aequalis Reversed Shoulder Prosthesis” (Approval No. 22500BZI00021000). (The original product is in a reexamination period) |
| Sep 9, 2015 | Freezor Cryoablation Catheter SeriesCardiovascular ablation catheter | Medtronic Japan Co., Ltd. | New device | Apr 17, 2003 | 149 mo later | 292 days | A catheter used in cryoablation of cardiac tissue for treatment of atrioventricular nodal reentry tachycardia (AVNRT). A clinical evaluation report summarizing results of foreign clinical studies and published literatures was submitted for evaluation of the efficacy and safety in treatment of AVNRT. (The original product is in a reexamination period) |
| Sep 2, 2015 | DELTA XTEND Reverse Shoulder System (Modular)Total shoulder prosthesis | Johnson & Johnson K.K. | New device | Feb 2, 2007 | 103 mo later | 306 days | A reverse total shoulder prosthesis used in cases of rotator cuff dysfunction to replace the shoulder joint function. The part of the components to be implanted within bones is applied with surface roughening by grit blasting and plasma spray coating of hydroxyapatite, allowing cementless fixation. A clinical evaluation report summarizing clinical data on foreign clinical literatures and foreign post-marketing surveillance was submitted to show the clinical equivalence of the product to overall reverse shoulder prostheses used in foreign countries. (The original product is in a reexamination period) |
| Sep 2, 2015 | DELTA XTEND Reverse Shoulder System (Monobloc)Humeral component for shoulder prosthesis | Johnson & Johnson K.K. | New device | Feb 2, 2007 | 103 mo later | 306 days | The humeral stem of a reverse shoulder prosthesis used in cases of rotator cuff dysfunction, to replace shoulder joint function. The devise is used in combination with the components of the “DELTA XTEND Reverse Shoulder System (Modular)” which have been filed simultaneously, and is fixed to bone with cement. A clinical evaluation report summarizing clinical data on foreign clinical literatures and foreign post-marketing surveillance was submitted to show the clinical equivalence of the product to overall reversed shoulder prostheses used in foreign countries. (The original product is in a reexamination period) |
| Aug 28, 2015 | MED-EL Middle Ear Implant VSBMiddle Ear Implant | MED-EL Elektro-Medizinische Ger äte GmbH | New device | Jun 27, 2003 | 146 mo later | 423 days | A middle ear implant system that processes signals incorporated from a microphone and vibrates a floating mass transducer implanted in the middle ear. Domestic clinical studies were conducted to confirm improved hearing in patients with conductive hearing loss or with mixed conductive- sensorineural hearing loss. |
| Aug 28, 2015 | Inoue Balloon for Aortic ValveBalloon-dilating catheter for valvuloplasty | Toray Industries, Inc. | New device | Not listed | — | 184 days | A balloon catheter used for percutaneous transluminal aortic valvuloplasty (PTAV) for aortic valve stenosis. The device has identical shape and structure to those of the approved product, Inoue Balloon for mitral valve (Approval No. 16300BZZ01718000). A clinical evaluation report was submitted to demonstrate the safety and efficacy on use of this product in PTAV. |
| Aug 26, 2015 | Straumann Implant (Roxolid SLActive) BLDental implant body | Straumann Japan K.K. | New device | Feb 26, 2009 | 78 mo later | 413 days | A bone level dental implant, which is placed into the jawbone and has a straight root apex. Similar to the approved device “Straumann Implant (SLActive) BL” (Approval No. 22600BZX00257000), this device is supplied in a sealed vial filled with normal saline to keep hydrophilic nature of titanium until just before use, which accelerates the osseointegration and enables the early loading. This device adopts a titanium alloy with zirconium as a raw material to improve strength as compared with the approved device made of pure titanium. Results from multicenter, randomized, comparative studies conducted in foreign countries were submitted to demonstrate that the device has a bone bonding ability equivalent to that of the approved device made of pure titanium. |
| Aug 13, 2015 | Comprehensive Reverse Shoulder SystemTotal shoulder prosthesis | Biomet Japan, LLC | New device | Jul 9, 2008 | 85 mo later | 360 days | A reverse shoulder prosthesis used in cases of rotator cuff dysfunction such as rotator cuff tear arthropathy or massive rotator cuff tear. The device consists of humeral and glenoid components, and is used in combination with the approved humeral stem. A clinical evaluation report summarizing clinical data on foreign clinical literatures and foreign post-marketing surveillance was submitted to show the clinical equivalence of the product to overall reverse shoulder prostheses used in foreign countries. (The original product is in a reexamination period) |
| Aug 13, 2015 | Trabecular Metal Reverse Shoulder System Vivacit-E Polyethylene LinerHumeral component for shoulder prosthesis | Zimmer K.K. | New device | May 12, 2014 | 15 mo later | 104 days | An insert consisting of humeral components of a reverse shoulder prosthesis used in cases of rotator cuff dysfunction such as rotator cuff tear arthropathy or massive rotator cuff tear. The insert adopts vitamin E blended highly crosslinked polyethylene as the raw material, which has already been used for the approved device. The device is used in combination with the humeral stem or other components of the company's own approved products, “Trabecular Metal Reverse Shoulder System” (Approval No. 22500BZX00475000). (The original product is in a reexamination period) |
| Aug 13, 2015 | SurefilterSlow continuous hemofilter | Nipro Corporation | New device | Not listed | — | 371 days | A slow continuous hemofilter used for elimination of unnecessary metabolites and excess fluid in the blood of patients with renal failure complicated by cardiovascular diseases such as multiple organ failure, severe complications, and edema. This device has novelty in that the material of the hollow fiber membrane is polyether sulfone. Clinical studies were conducted to evaluate the usefulness of this device in patients with acute renal failure, etc., for whom slow continuous hemofiltration is indicated. |
| Aug 7, 2015 | UltimasterCoronary stent | Terumo Corporation | New device | Not listed | — | 346 days | A coronary stent system consisting of a sirolimus- eluting stent used for the treatment of patients with symptomatic ischemic heart disease and a delivery catheter used to implant the stent at stenotic lesions. The coating layer of the stent is composed of sirolimus and bioabsorbable polymer only, so that the stent behaves as a bare-metal stent in the late phase after the stent implantation. Results from the global clinical trials conducted to evaluate the efficacy and safety of this device for patients with symptomatic ischemic heart disease were submitted. |
| Aug 5, 2015 | Revolix 120Thulium YAG laser | Takai Hospital Supply Co,. Ltd. | New device | Mar 26, 2007 | 100 mo later | 390 days | A thulium YAG laser used for incision, hemostasis, coagulation and vaporization of soft biological tissue under direct vision or endoscopy. This device is also used for treatment of prostatic hyperplasia. Laser light irradiated from this device (wavelength of 2.0 μm, continuous wave) has a similar wavelength of the approved product, the holmium YAG laser (wavelength of 2.1 μm, pulse wave). However, this device irradiates a continuous wave and has increased maximum output as compared with that of the approved device. A clinical evaluation report was submitted to compare and evaluate the treatment outcomes between this device and existing therapies for transurethral prostate treatment, in which the high output is utilized. |
| Jul 23, 2015 | Cook Zenith AAA-LP Endovascular GraftAortic stent graft | Cook Japan Inc. | New device | Not listed | — | 266 days | A stent graft system for abdominal aortic aneurysms which has the basic structure of the company's own approved product “Cook Zenith AAA Endovascular Graft” (Approval No. 21800BZY10175000) with the smaller outer diameter of the delivery catheter achieved by thinning the graft material. Results from domestic and foreign clinical studies were submitted for the evaluation of the efficacy and safety of this device for patients with abdominal aortic aneurysm. |
| Jul 17, 2015 | Straumann Implant (Roxolid SLActive) BLTDental implant body | Straumann Japan K.K. | New device | Aug 20, 2014 | 11 mo later | 263 days | A bone level dental implant, which is to be placed into the jawbone and has an apically tapered root apex. Similar to the approved device “Straumann Implant (SLActive) BL” (Approval No. 22600BZX00257000), this device is supplied in a sealed vial filled with normal saline to keep hydrophilic nature of titanium until just before use, which accelerates the osseointegration and enables the early loading. This device has the identical shape and roughened surface treatment to the previously approved device “Straumann Implant (Ti SLA) BLT” (Approval No. 22700BZX00167000). However, this device adopts a titanium alloy with zirconium as a raw material to improve strength as compared with the approved device made of pure titanium. Results from multicenter, randomized, comparative studies conducted in foreign countries were submitted to demonstrate that the device has a bone bonding ability equivalent to that of the approved device made of pure titanium. |
| Jul 8, 2015 | Catalys Precision LaserOphthalmic pulsed laser surgical instrument | AMO Japan K.K. | New device | Dec 21, 2011 | 43 mo later | 265 days | An ophthalmic pulsed laser surgical instrument used for the anterior capsulotomy, the lens fragmentation, and creation of corneal incisions in cataract surgery. A foreign clinical study was conducted to confirm that this device has no particular issues as compared with the conventional standard technique used in cataract surgery. |
| Jun 24, 2015 | ERBE JET2Hydraulic knife | AMCO Inc. | New device | Sep 4, 2007 | 94 mo later | 1470 days | A hydraulic knife used for incision, ablation, or resection of liver tissue. This knife incises, ablates, or resects the liver tissue using the hydraulic pressure energy of a high pressure water jetting from the tip of hand-held applicator. A clinical evaluation report was provided in order to evaluate that the safety of the technique using this product was not inferior to the conventional technique. |
| Jun 22, 2015 | Assurity MRIImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 214 days | The device is an implantable cardiac pacemaker to regulate the heart rhythm by delivering the electrical stimulus to myocardium for a long period. The patients implanted with the device can have an MRI scan under specific conditions. A clinical evaluation report summarizing the results of the foreign clinical studies related to the device was submitted to evaluate the safety of the device on MRI scan. |
| Jun 22, 2015 | Gore Viabahn Stent GraftHeparin-coated stent-graft for central circulatory system | W. L. Gore & Associates, Co., Ltd. | New device | Not listed | — | 214 days | The device is an implantable cardiac pacemaker to regulate the heart rhythm by delivering the electrical stimulus to myocardium for a long period. The patients implanted with the device can have an MRI scan under specific conditions. A clinical evaluation report summarizing the results of the foreign clinical studies related to the device was submitted to evaluate the safety of the device on MRI scan. |
| Jun 18, 2015 | EXCOR Pediatric Ventricular Assist DeviceSingle-use extracorporeal assistant artificial cardiac pump | Cardio Incorporated | New device | Dec 16, 2011 | 42 mo later | 212 days | The device is an external ventricular assist system used for improving circulation of pediatric severe heart failure patients. Foreign clinical study reports to evaluate the survival rate, survival period, adverse events, etc. in pediatric patients using the device and a Japanese clinical study report to confirm the compatibility of the device with the domestic medical environment were submitted. [Orphan device] |
| Jun 9, 2015 | Restylane LidoMedical Products 4 Injectable material to a soft tissue using hyaluronic acid | Galderma KK | New device | Jan 29, 2010 | 64 mo later | 473 days | An injectable material into soft-tissue made of hyaluronic acid designed to improve appearance of facial wrinkles and folds, which is indicated for injection into the mid to deep dermis. Lidocaine hydrochloride is added to relieve pain at the time of injection. A report on prospective, randomized, within-subject controlled study conducted in the United States, and 3 additional clinical study reports were submitted in order to verify the effects on correction of nasolabial fold and pain relief. |
| Jun 9, 2015 | Restylane Perlane LidoMedical Products 4 Injectable material to a soft tissue using hyaluronic acid | Galderma KK | New device | Jan 29, 2010 | 64 mo later | 473 days | An injectable material into soft-tissue made of hyaluronic acid designed to improve appearance of facial wrinkles and folds, which is indicated for injection into the deep dermis to superficial subcutis. Lidocaine hydrochloride is added to relieve pain at the time of injection. A report on prospective, randomized, within-subject controlled study conducted in Europe, and 5 additional clinical study reports were submitted in order to verify the effects on correction of nasolabial fold and pain relief. |
| May 26, 2015 | EC-PDT ProbeSingle-use probe for PDT semiconductor laser | Panasonic Healthcare Co., Ltd. | New device | Not listed | — | 244 days | A probe for laser irradiation used for photodynamic therapy using talaporfin sodium for recurrent esophageal cancer associated with local persistence after chemoradiotherapy or radiotherapy. This probe is connected to PD Laser to irradiate the target lesion from the esophageal lumen with laser light oscillated from PD Laser. Results from a domestic phase II study (an investigator-initiated clinical trial) conducted to evaluate the efficacy and safety of photodynamic therapy using talaporfin sodium, PD Laser, and this product for recurrent esophageal cancer associated with local persistence after chemoradiotherapy or radiotherapy were submitted. [Orphan device] |
| Apr 21, 2015 | Juvederm Vista Ultra XCMedical Products 4 Injectable material to a soft tissue using hyaluronic acid | Allergan Japan KK | New device | Jan 7, 2010 | 63 mo later | 299 days | An injectable material into soft-tissue using hyaluronic acid used to correct facial wrinkles and folds. The product is "Juvederm Vista Ultra" (22600BZX00108000), an existing approved product of Allergan Japan KK, with added lidocaine hydrochloride to relieve pain at the time of treatment. Results from randomized, within- subject controlled studies conducted in the United States were submitted to verify the effect of pain relief compared to that of the existing approved product. |
| Apr 21, 2015 | Juvederm Vista Ultra Plus XCMedical Products 4 Injectable material to a soft tissue using hyaluronic acid | Allergan Japan KK | New device | Jan 7, 2010 | 63 mo later | 299 days | An injectable material into soft-tissue using hyaluronic acid used to correct facial wrinkles and folds. The product is "Juvederm Vista Ultra Plus" (22600BZX00109000), an existing approved product of Allergan Japan KK, with added lidocaine hydrochloride to relieve pain at the time of treatment. Results from randomized, within- subject controlled studies conducted in the United States were submitted to verify the effect of pain relief compared to that of the existing approved product. |
| Apr 17, 2015 | Pipeline Flex Flow Diverter SystemProsthetic material for embolization in vessels of the central circulation system | Covidien Japan, Inc. | New device | Jan 26, 2015 | 3 mo later | 219 days | A flow diverter system used for endovascular therapy for large or giant wide-neck intracranial aneurysm in internal carotid artery from petrous through superior hypophyseal, except for the acute phase of aneurysm that are at risk of rupture. Results from foreign clinical studies conducted to evaluate the efficacy and safety of this product in the treatment of intracranial aneurysm and domestic clinical studies conducted to confirm the compatibility of this product with the domestic medical environment were submitted. [Priority review product] |
| Apr 17, 2015 | LVIS StentProsthetic material for embolization in vessels of the central circulation system | Terumo Corporation | New device | Jul 15, 2014 | 9 mo later | 361 days | A prosthetic material for embolization in vessels of the central circulation system to prevent the protrusion and/or dislodgement of embolic coils into/from the parent artery during coil embolization in patients who have a wide-neck cerebral aneurysm (defined as that with a neck part of 4 mm or greater, or dome/neck ratio of less than 2) in the parent artery with a diameter of 2.0 to 4.5 mm, among the patients who have an unruptured aneurysm (with a maximum diameter of 5 mm or greater) which is difficult to treat surgically (including surgical clipping) or by coil embolization using an embolization coil alone. This product is a stent formed with woven nitinol wire, which is expected to improve the tracking of vessel shape and is a closed-cell stent with characteristic of no cell opening or no protrusion into cerebral aneurysm. Results from domestic clinical studies conducted to evaluate the efficacy and safety of this product in treatment of aneurysm were submitted. (The original product is in a reexamination period) |
| Apr 17, 2015 | S-ICD LeadImplantable defibrillator /pacemaker lead | Boston Scientific Japan K.K. | New device | Sep 28, 2012 | 31 mo later | 322 days | The device is a subcutaneous implantable cardioverter-defibrillator (S-ICD) lead used in patients at high risk of sudden cardiac death caused by ventricular tachycardia. Foreign clinical study reports were submitted to evaluate the efficacy and safety of the device for treatment of lethal arrhythmia. |
| Apr 17, 2015 | S-ICD Pulse GeneratorAutomatic implantable defibrillator | Boston Scientific Japan K.K. | New device | Sep 28, 2012 | 31 mo later | 322 days | The device is a subcutaneous implantable cardioverter-defibrillator (S-ICD) used in patients at high risk of sudden cardiac death caused by ventricular tachycardia. Foreign clinical study reports were submitted to evaluate the efficacy and safety of the device for treatment of lethal arrhythmia. |
| Mar 25, 2015 | CoreValveTranscatheter porcine pericardial valve | Medtronic Japan Co., Ltd. | New device | Jan 17, 2014 | 14 mo later | 357 days | A self-expanding biological percutaneous aortic valve (porcine pericardial valve) system is used for transcatheter valve implantation in the native aortic valve for patients with symptomatic severe aortic stenosis attributed to sclerosis and degeneration of the cusp of the native aortic valve, for whom surgery cannot be performed. A clinical study was conducted to evaluate the efficacy and safety of this product and to confirm the compatibility to the domestic medical environment. |
| Mar 25, 2015 | NovoTTF-100A SystemAlternating electric field tumor treatment system | NovoCure Ltd. | New device | Apr 8, 2011 | 48 mo later | 266 days | The medical device is a non-invasive device that delivers alternating electric fields -referred to as Tumor Treating Fields (TTfield) - that inhibit cancer cell replication and cause cancer cell death. TTFields are delivered to the tumor in the brain through insulated transducer arrays (INE transducer array) that are placed on the scalp. A clinical trial was conducted to compare the efficacy and safety of the device to chemotherapy in patients with recurrent glioblastoma multiforme after receiving all possible surgery and radiation therapy options. [Priority review] |
| Mar 4, 2015 | Itrevia 7 CRT-D QP ProMRIImplantable biventricular pacing pulse generator with defibrillator function | Biotronik Japan, Inc. | New device | Not listed | — | 132 days | The device is an implantable biventricular pacing pulse generator with a defibrillator function implanted in the chest or abdomen for the treatment of ventricular tachycardia, etc. by ventricular sensing, pacing and defibrillation. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. A clinical evaluation report was submitted to confirm the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Mar 4, 2015 | Sentus ProMRI OTW QPImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 132 days | The device is a pacemaker lead with four electrodes at its tip used by placing it in the coronary vein and connecting it to an implantable pulse generator. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. A clinical evaluation report was submitted to confirm the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Feb 12, 2015 | ASSURANT COBALT StentStent for iliac artery | Medtronic Japan Co., Ltd. | New device | Oct 26, 2011 | 40 mo later | 116 days | A balloon expandable stent and the delivery system used to maintain the patency of the vessel lumen of de novo and restenotic symptomatic lesions in the common iliac artery and external iliac artery. A clinical study was conducted to evaluate the efficacy and safety of this product in clinical use. |
| Feb 6, 2015 | Duolith SD1Extracorporeal shock wave pain therapy system | Storz Medical AG | New device | Not listed | — | 196 days | An extracorporeal shock wave pain therapy system designed to enable adjustment of output by the conventional electromagnetic induction-type extracorporeal shock wave lithotripter to the low power output. It is used for pain relief in patients with refractory plantar aponeurositis. A clinical study was conducted to evaluate the efficacy and safety of this product in patients with refractory plantar aponeurositis. |
| Feb 3, 2015 | Kora 100Implantable cardiac pacemaker | Sorin CRM SAS | New device | Not listed | — | 417 days | The device is an implantable cardiac pacemaker used by connecting it to electrodes placed in the heart. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. A clinical evaluation report was submitted to confirm the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jan 23, 2015 | Tapered Screw-Vent XIntraosseous dental implant | Zimmer K.K. | New device | Dec 14, 2011 | 37 mo later | 319 days | An implant fixture partially or wholly implanted in the jawbone, which supports for the upper structure. In order to confirm the bone fixation performance of the new structure with a porous structure on the surface, a clinical evaluation report created from clinical results in published literatures on this product was submitted to evaluate the clinical performance in addition to the normal performance evaluation test. |
| Jan 23, 2015 | Gore Acuseal Vascular GraftArtificial blood vessel using heparin of the non-central circulation system | W.L. GORE & Associates, Co., Ltd. | New device | Apr 9, 2013 | 21 mo later | 100 days | An artificial triple-layered blood vessel used for vascular access. The lumen is coated with heparin. A clinical study was conducted to evaluate the efficacy and safety of this product in patients requiring hemodialysis. |
| Jan 19, 2015 | Outback Re-entry CatheterVascular recanalization catheter | Johnson & Johnson K.K. | New device | Jan 21, 2005 | 120 mo later | 220 days | A catheter consisting of a cannula, an outer shaft, a lure assembly and a handle. It assists recanalization back into the true lumen with a guidewire advanced via the subintimal space during percutaneous angioplasty to treat chronic total occlusion in the region of the femoropopliteal artery. A clinical evaluation report has been created based on the reports that were collected from an adverse-event database with clinical results and published literatures. The clinical report was submitted to confirm the performance and safety of this product to be used for the lesions with chronic total occlusion. |
| Dec 24, 2014 | BIOPATCH Protective Disk with CHGProtective patch for puncture site | Johnson & Johnson K.K. | New device | Oct 26, 2001 | 158 mo later | 398 days | A sterilized disk pad with a slit, which consists of a layer of polyurethane foam impregnated with chlorhexidine gluconate antimicrobial constituent and a covering layer of foam. This product protects the insertion site of various percutaneous devices by covering the site and absorbing the fluids like wound exudate. In patients who are inserted with central venous or arterial catheters, this product also reduces the incidence of catheter- related bloodstream infections and local infections. Clinical evaluation report summarizing the clinical results on this product was submitted to evaluate the reduction of catheter-related bloodstream infections and safety of this product. |
| Dec 22, 2014 | Navvus CatheterCentral circulation system transducer- tipped catheter | ACIST Medical Systems, Inc. | New device | Jan 30, 2014 | 11 mo later | 268 days | The device is a catheter with a pressure sensor at the distal tip. It is used for invasive measuring of intravascular pressure in the central and non-central circulation systems excluding the cerebral blood vessel and carotid artery, and also used for evaluation of hemodynamics. The catheter type was adopted to enhance the operability by comparing with a conventional wire type of a similar medical device. The data on results of clinical study to compare the measurement accuracy with that of a previously approved product "SJM PressureWire Certus" (Approval No.: 22300BZX00247000) was submitted. |
| Dec 3, 2014 | Orthofix HA Coating PinInternal fixation pin | Orthofix S. r. l. | New device | Mar 18, 1998 | 201 mo later | 85 days | A stainless steel pin used with external fixators. No products such as pins coated with hydroxyapatite to enhance the fixation have been approved in Japan. Therefore, in addition to the results of a tensile strength test, a clinical evaluation report summarizing overseas published papers was submitted to evaluate the efficacy and safety of fixation with this product. |
| Nov 28, 2014 | Promus Premier LV Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Nov 21, 2013 | 12 mo later | 164 days | A stent system for percutaneous coronary stent placement consisting of a everolimus-eluting stent with diameter of 4.0 mm to be inserted and placed at the site of a lesion to maintain the patency of the vascular lumen and a delivery catheter used to deliver the stent to the site of the lesion. The product having a diameter of 2.25 - 3.5 mm was previously approved in Japan as "Promus Premier Stent System" (Approval No.: 22600BZX00181000). A clinical study was conducted to evaluate the efficacy and safety of the stent with a 4.0 mm diameter. |
| Nov 26, 2014 | Vercise DBS SystemElectrical brain stimulation device for tremor | Boston Scientific Japan K.K. | New device | Not listed | — | 115 days | The device is an electrical brain stimulation device used to reduce tremors that do not sufficiently respond to drug therapy and symptoms of movement disorder associated with Parkinson's disease by providing an electrical stimulus unilaterally or bilaterally to the deep brain (thalamus, subthalamic nucleus or internal globus pallidus). This device consists of an implantable pulse generator and lead, an external trial stimulator to evaluate presence or absence of effect by test stimulation, and a remote controller to control stimulation parameter. Foreign clinical study results to evaluate the efficacy and safety in patients with Parkinson's disease and a clinical evaluation report summarizing foreign clinical studies and published papers to evaluate the efficacy and safety in patients with tremors were submitted. |
| Nov 20, 2014 | Steering MicrocatheterCentral circulation system Microcatheter | Akita Sumitomo Bakelite Co., Ltd. | New device | Not listed | — | 181 days | An intravascular microcatheter for the central circulation system (except for the cardiac and cerebral [intracranial] vessels) used for selective angiography, drug infusion and embolization. The direction of the catheter tip can be controlled by rotating a dial and thereby the catheter can be inserted selectively into the bent vessels without a guidewire. The results of a domestic clinical study was submitted to confirm the efficacy and safety of this product that enables directional operation of the catheter tip by the dial. |
| Nov 17, 2014 | Iperia 7 ICD DF-1 ProMRIAutomatic implantable defibrillator | Biotronik Japan, Inc. | New device | Not listed | — | 130 days | The device is an implantable cardiac defibrillator used by connecting it to electrodes placed in the heart. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. This product was developed based on the approved product "Ilesto 7 ICD Pro" (Approval No.: 22500BZX00292000). The major improvements from the approved product include the addition of conditions for the strength of static magnetic field used in MRI and an additional function for detecting ventricular tachycardia. A clinical evaluation report summarizing foreign clinical study results related to this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Nov 17, 2014 | Itrevia 7 CRT-D ProMRIImplantable biventricular pacing pulse generator with defibrillator function | Biotronik Japan, Inc. | New device | Not listed | — | 105 days | The device is an implantable biventricular pacing pulse generator with defibrillator function used by connecting it to electrodes placed in the heart. Patients implanted with the device can conditionally undergo an MRI scan only when the patient's condition is suitable for the requirements for imaging. This product was developed based on the approved product "Ilesto 7 CRT-D Pro" (Approval No.: 22500BZX00293000). The major improvement from the approved product is an additional function of ventricular tachycardia detection. A clinical evaluation report summarizing foreign clinical study results related to this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Nov 17, 2014 | Vival Coronary StentCoronary stent | Goodman Co., LTD. | New device | Not listed | — | 250 days | A stent system for percutaneous coronary stent placement consisting of a stent to be placed at the narrowed or blocked segment of coronary artery to maintain the patency of the vascular lumen and a delivery catheter used to deliver the stent to the site of the lesion and dilate the stent. The raw materials were changed from those of the "Duraflex Coronary Stent" (Approval No.: 21500BZY00516000) to reduce the thickness of the stent, and the delivery catheter was also changed. A domestic clinical study was conducted to evaluate the efficacy and safety of this product in patients with symptomatic ischemic heart diseases who have a new stenosis or restenosis lesion in a coronary artery (a lesion length of 25 mm or less). |
| Nov 7, 2014 | COOK Zenith Dissection Endovascular SystemAortic stent graft | Cook Japan Inc. | New device | Not listed | — | 728 days | A stent graft system used for the treatment of acute complicated Stanford type B aortic dissection, consisting of a stent graft that is placed to close the primary entry tear, a bare stent that enlarges compressed or narrowed intravascular lumen due to aortic dissection, and a delivery system that delivers/places them in the lesions. Results from clinical studies were submitted to evaluate efficacy and safety on this product for patients with acute complicated Stanford type B aortic dissection. |
| Oct 9, 2014 | Lima Reverse Shoulder SystemTotal shoulder prosthesis | Lima Japan K.K. | New device | Aug 18, 2011 | 38 mo later | 197 days | A shoulder prosthesis having the concept of a reversed shoulder prosthesis system in which the anatomical structure is reversed. It is used for cases of rotator cuff dysfunction such as a massive rotator cuff tears or rotator cuff tear arthropathy. When it is difficult to be combined with a reversed shape, it can be combined with an anatomical shape in humerus or total shoulder joint replacement. A clinical evaluation report was submitted to confirm that the efficacy and safety of this device are equivalent to the existing approved devices based on overseas usage histories and publications of this device and similar devices. |
| Sep 25, 2014 | Evera MRI ICD SeriesAutomatic implantable defibrillator | Medtronic Japan Co., Ltd. | New device | Not listed | — | 209 days | An implantable defibrillator intended for the treatment of ventricular tachycardia, etc. The patients implanted with the device can conditionally undergo an MRI scan. This is a new application for the product with which an MRI scan can be conditionally conducted, based on the company’s own approved products. In order to evaluate the safety of this product in MRI scans, results of clinical studies using the original product were submitted, in which the extrapolability in the evaluation was explained. (The original product is in a reexamination period) |
| Sep 25, 2014 | Sprint Quattro MRI Screw-In LeadImplantable defibrillator/ pacemaker lead | Medtronic Japan Co., Ltd. | New device | Not listed | — | 209 days | An implantable catheter electrode connected with an implantable defibrillator and a defibrillator with biventricular pacing. The patients implanted with the device can conditionally undergo an MRI scan. This is a new application for the product with which an MRI scan can be conditionally conducted, based on the company’s own approved products. In order to evaluate the safety of this product in MRI scans, results of clinical studies using the original product were submitted, in which the extrapolability in the evaluation was explained. (The original product is in a reexamination period) |
| Sep 25, 2014 | Sprint Quattro MRI Screw-In Lead SImplantable defibrillator/ pacemaker lead | Medtronic Japan Co., Ltd. | New device | Not listed | — | 209 days | An implantable catheter electrode connected with an implantable defibrillator and a defibrillator with biventricular pacing. The patients implanted with the device can conditionally undergo an MRI scan. This is a new application for the product with which an MRI scan can be conditionally conducted, based on the company’s own approved products. In order to evaluate the safety of this product in MRI scans, results of clinical studies using the original product were submitted, in which the extrapolability in the evaluation was explained. (The original product is in a reexamination period) |
| Sep 17, 2014 | Alair Bronchial Thermoplasty SystemBronchial thermoplasty catheter system | Boston Scientific Japan K.K. | New device | Apr 27, 2010 | 53 mo later | 265 days | A catheter system used to apply high frequency energization to the bronchial wall to reduce asthmatic symptoms in patients aged 18 or older with severe asthma whose asthmatic symptoms are not well controlled with high-dose inhaled steroids and long- acting beta2-agonists. Foreign clinical studies were conducted to demonstrate its relieving effect on asthmatic symptoms. |
| Sep 10, 2014 | Cook Evolution Duodenal Stent SystemGastroduodenal stent | Cook Japan Inc. | New device | Mar 29, 2011 | 41 mo later | 84 days | A stent system to place a stent by endoscopically inserting a delivery system to maintain patency in gastroduodenal obstruction and duodenal stenosis associated with malignant tumors in patients for whom alleviative gastrectomy is considered difficult to be performed or other treatments is unlikely to have an effect. A clinical evaluation report was submitted to confirm the efficacy and safety of treatment using this stent in patients with malignant gastric outlet obstruction. |
| Sep 9, 2014 | Sentus ProMRI OTW BPImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 187 days | A pacemaker lead connected with an implantable pulse generator and implanted in the coronary vein. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report summarizing clinical data on this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Aug 29, 2014 | TransForm Occlusion Balloon CatheterIntravascular catheter for embolization of the central circulation system | Stryker Japan K.K. | New device | Jan 11, 2013 | 20 mo later | 118 days | An intravascular catheter for embolization of the central circulation system used for temporary interruption of blood flow in percutaneous intravascular surgery or for prevention of a coil mass from protruding into and/or prolapsing into the parent artery as an adjunct of coil embolization for cerebral aneurysms. A clinical evaluation report was submitted to confirm the efficacy and safety of balloon-assisted coil embolization using this device. |
| Aug 25, 2014 | LenSx Laser SystemOphthalmic pulsed laser surgical instrument | Alcon Japan Ltd. | New device | Oct 18, 2010 | 46 mo later | 66 days | An ophthalmic pulsed laser surgical instrument used for incision of anterior lens capsule, split of crystalline lens and corneal incision in cataract surgery. It consists of main body of the laser oscillator and patient interface that sucks and fixes the affected patient's eye. Although in conventional cataract surgery, incision of the anterior lens capsule, split of crystalline lens and corneal incision are performed using a cystotome, ultrasonic shock wave generated by cataract surgery instrument and ophthalmic knife, respectively, this device enables these procedures to be performed consecutively or in arbitrary combinations of each function using a femtosecond laser having a maximum energy of 15 microjoules. A foreign clinical study was conducted to confirm that this product has no particular problems by comparing this method to existing methods in cataract surgery. |
| Aug 19, 2014 | TVC Imaging SystemCardiovascular ultrasonic diagnostic imaging instrument | Nipro Corporation | New device | Jun 30, 2010 | 50 mo later | 252 days | The device is a device to visualize the form and characteristics of the vascular lumen and wall in the central circulation system and to provide the image data for diagnosis. This device has a function to detect a lipid core plaque using near-infrared light and to provide image data combined with an ultrasonogram. However, the image detected by this function is not intended to diagnose. A clinical study was conducted to evaluate that the device can detect a lipid core plaque using near-infrared light. |
| Aug 19, 2014 | TVC Insight CatheterCentral circulation system intravascular ultrasound catheter | Nipro Corporation | New device | Jun 30, 2010 | 50 mo later | 159 days | The device is a catheter equipped with a transducer for sending and receiving ultrasound on the tip to visualize the form and characteristics of the vascular lumen and wall in the central circulation system. This device is also equipped with an optical mirror and an optical fiber that irradiate and collect near-infrared light to detect a lipid core plaque and to provide image data combined with an ultrasonogram. However, the image detected by near-infrared light is not intended to diagnose. A clinical study was conducted to evaluate that the device can detect a lipid core plaque using near-infrared light. |
| Aug 8, 2014 | ccNexfin Hemodynamic MonitorMonitor of arterial blood pressure and cardiac output | Edwards Lifesciences Limited | New device | Oct 28, 2010 | 45 mo later | 197 days | The device is an apparatus for continuously monitoring hemodynamic parameters including systolic/diastolic blood pressures (BP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR). The hemodynamic parameters are calculated from arterial blood pressure waveform at the fingertips measured non-invasively and continuously by using the volume-clamp method. Non-clinical study and foreign clinical study results were submitted as the evaluation data on the efficacy and safety of this product. |
| Aug 5, 2014 | Iforia 7 ICD ProMRIAutomatic implantable defibrillator | Biotronik Japan, Inc. | New device | Not listed | — | 89 days | An implantable defibrillator connected with electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report summarizing clinical data on this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Aug 1, 2014 | AORFIX AAA Stent Graft SystemAortic stent graft | Medico's Hirata Inc. | New device | Feb 14, 2013 | 18 mo later | 265 days | An aortic stent graft system consisting of a stent graft and delivery system used for intravascular treatment of abdominal aortic aneurysms and aortic aneurysms extended from the abdominal aorta to the iliac artery. For the indication of infrarenal aortic aneurysm, although an existing approved stent graft for abdominal aortic aneurysms is limited to treat patients with an aortic neck angle not greater than 60 degrees, this product enable to treat patients with the angles of up to 90 degrees. A foreign clinical study was conducted to evaluate the efficacy and safety of this product in case groups where the aortic neck angles are ranging from 60 degrees to 90 degrees. |
| Jul 25, 2014 | MOMO Coronary Stent SystemCoronary stent | Japan Stent Technology Co., Ltd. | New device | Not listed | — | 183 days | A coronary stent consisting of a stent to be inserted and placed at the site of a lesion to maintain the patency of the vascular lumen and a delivery catheter used to deliver the stent to the site of the lesion in percutaneous coronary stent placement. This stent is made of a cobalt-chromium alloy and the surface is coated with a diamond-like carbon to reduce in-stent restenosis. A domestic clinical study was conducted to verify the efficacy and safety of this product in patients with symptomatic ischemic heart disease who have a new stenosis or restenosis of a coronary lesion (lesion length is 26 mm or less) with a reference vascular diameter ranging from 3.0 mm to 4.0 mm. |
| Jul 9, 2014 | EHL AutolithIntracorporeal electrohydraulic shock wave lithotriptor | AMCO Inc. | New device | Jan 28, 1993 | 257 mo later | 159 days | An intracorporeal electrohydraulic shock wave lithotriptor used to crush calculuses in the kidney and bladder (urinary calculus) and bileduct stone using an electrohydraulic shock wave. A clinical evaluation report was submitted to evaluate the efficacy and safety of this product in patients with bile duct stone. |
| Jul 3, 2014 | Radioactive Pharmaceutical Synthesizer NEPTIS Plug-01Radiopharmaceutical synthesizer | Eli Lilly Japan K.K. | New device | Not listed | — | 415 days | A radioactive pharmaceutical synthesizer used for the semi-automated preparation of a radioisotope labeled compound, florbetapir (18F) injection by remote control system indicated for the visualization of beta-amyloid plaque in the brain in patients with cognitive impairment who are suspected of having Alzheimer's disease. Results from non-clinical studies, and domestic and foreign clinical studies were submitted as evaluation data on the efficacy and safety of this product and florbetapir (18F) injection. |
| Jun 23, 2014 | OASIS Extracellular MatrixCollagen-based artificial skin | Cook Japan Inc. | New device | Apr 30, 1998 | 194 mo later | 281 days | Collagen-based artificial skin for control and treatment of full and partial thickness wounds. Porcine small-intestinal submucosa is used as a raw material. Viral clearance study results were submitted to evaluate the virus safety of this product. In addition, foreign post-marketing clinical study results were submitted to evaluate the efficacy and safety in clinical use for patients with venous ulceration and pressure ulcers (decubitus ulcers). |
| Jun 11, 2014 | Straumann Implant (SLActive) BLDental implant body | Straumann Japan K.K. | New device | Jun 30, 2004 | 119 mo later | 76 days | Pure titanium dental implant body having the roughened surface by sandblasting and acid etching. This product is a bone level type of the company's approved product "Straumann Implant (SLActive) TL" (Approval No.: 22600BZX00016000), which accelerates osteointegration and enables earlier loading by providing the product sealed into a vial filled with normal saline to keep the hydrophilic nature of titanium until just before use. A domestic clinical study on an implant of 4.1mm in diameter was conducted to evaluate its efficacy and safety in early loading compared to in conventional loading. In addition, results of foreign clinical studies on a thinner implant of 3.3mm in diameter were submitted. |
| Jun 5, 2014 | Etrinsa 8-T ProMRIImplantable cardiac pacemaker | Biotronik Japan, Inc. | New device | Not listed | — | 108 days | An implantable cardiac pacemaker to be used by connecting it to electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jun 5, 2014 | Etrinsa 6 ProMRIImplantable cardiac pacemaker | Biotronik Japan, Inc. | New device | Not listed | — | 108 days | An implantable cardiac pacemaker to be used by connecting it to electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| May 30, 2014 | Entovis MRIImplantable cardiac pacemaker | Biotronik Japan, Inc. | New device | Not listed | — | 287 days | An implantable cardiac pacemaker to be used by connecting it to electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| May 30, 2014 | Safio SEndocardial implantable pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 287 days | An endocardial implantable pacemaker lead connected with an implantable cardiac pacemaker. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| May 29, 2014 | AMPLATZER Vascular Plug 4Prosthetic material for embolization in vessels of the central circulation system | St. Jude Medical Japan Co., Ltd. | New device | Jun 12, 2012 | 24 mo later | 358 days | This device is used to occlude blood vessels, and reduce, block, or modify blood flow, by transdermally inserting and placing it in arteries/veins, except blood vessels within the heart and the skull. It was changed to a form with two conical blocks, and improved its components to reduce the profile of the whole plug (the diameter in its closed state) so that the device can be advanced through an imaging catheter, maintaining the same barrier area to blood flow as that of the approved product “AMPLATZER Vascular Plug (approval No.: 22400BZX00361000) (hereinafter referred to as AVP). Results from domestic clinical studies using AVP were submitted as clinical data of this product because several non-clinical studies including design verification and animal studies had shown that the same efficiency of this product is secured as that of AVP. |
| May 26, 2014 | HEALICOIL RG Suture AnchorAbsorbable ligament fixation | Smith & Nephew Endoscopy KK | New device | Apr 11, 2013 | 13 mo later | 91 days | A suture anchor used to fix soft tissues of the tendons and ligaments to the bones of the shoulder, elbow, groin (gluteal tendons), knee and foot/ankle. It consists of an absorbable anchor that adopts the hollow coil configuration of the approved product "HEALICOIL Suture Anchor" (Approval No.: 22500BZX00193000), sutures and an inserter. The point of improvement is that a glycolic acid/L-lactic copolymer and a mixture of calcium sulfate and beta- tricalcium phosphate which are new bioabsorbable materials, were adopted as raw materials. The results of a domestic clinical study on arthroscopic labrum repair in shoulder for traumatic shoulder instability using "Osteoraptor OS Anchor" (Approval No.: 22600BZX00228000) made of the same raw materials as this product were submitted to confirm the efficacy and safety of the new bioabsorbable materials. |
| May 26, 2014 | PICO Wound Therapy SystemSingle-use negative pressure wound therapy system | Smith & Nephew Wound Management KK | New device | May 18, 2012 | 24 mo later | 119 days | A negative pressure wound therapy system to promote wound healing by providing a locally managed negative-pressure for patients with a refractory wound who have not responded to or are considered to be unlikely to respond to existing treatment. This device consists of a negative pressure maintenance unit, dressing and a tube to connect the unit and the dressing. Exudate is retained in the dressing applied to wound area and transpired through the backing film. The point of improvement from the approved product "RENASYS Wound Therapy System" (Approval No: 22400BZX00276000) is a downsizing and weight lightening of the main body of the device which allows the device to be used for outpatient. A clinical study on inpatients and outpatients was conducted to evaluate if the performance of this device was equivalent to that of approved product, and to confirm any defects or adverse events specific to this product. |
| May 26, 2014 | Osteoraptor OS AnchorAbsorbable ligament fixation | Smith & Nephew Endoscopy KK | New device | Jan 27, 2011 | 40 mo later | 103 days | A suture anchor used to fix the soft tissues of tendons and ligaments to the bone in the shoulder, elbow, wrist/hand, groin, knee and foot/ankle. It consists of an absorbable anchor, sutures and an inserter. The point of improvement is that a glycolic acid/L-lactic acid copolymer and a mixture of calcium sulfate and beta-tricalcium phosphate which are new bioabsorbable materials, were adopted as raw materials for the anchor. The results of a domestic clinical study on arthroscopic labrum repair in shoulder for traumatic shoulder instability using this device were submitted to confirm the efficacy and safety of the new bioabsorbable materials. |
| May 7, 2014 | VEPTR II SystemInternal fixation system | Johnson & Johnson K.K. | New device | May 31, 2007 | 83 mo later | 116 days | An internal fixation system made of titanium alloy and titanium which corrects thoracic deformity while allowing further growth of thorax by implanting an expandable metallic rod which is extendable along body axial direction in the thorax of the patients with thoracic insufficiency syndrome. Based on the approved product "VEPTR system (Approved No.: 22000BZX01655000)", and major difference from the approved product is that the usability and compatibility of this device with the patient's thorax were enhanced by adding variations on the components or improving the components. A clinical evaluation was conducted with the literatures on this product and the approved product, overseas safety information and clinical evaluation report based on a use-results survey of the approved product to confirm that efficacy and safety of this device equivalent to or greater than that of the approved product were also maintained by the differences. |
| Apr 7, 2014 | Promus Premier Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Nov 21, 2013 | 5 mo later | 255 days | A stent system consisting of a drug-eluting stent coated with everolimus to inhibit neointimal proliferation and a delivery catheter. The delivery catheter was improved by adding a link at the proximal end of a stent to produce axial strength to be superior to the original product. Clinical studies were conducted to confirm the efficacy and safety of this product in the treatment of symptomatic ischemic diseases. |
| Apr 3, 2014 | Alcon Acrysof IQ Restor +2.5D Single-PieceMultifocal posterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 83 days | A multifocal posterior chamber lens to be inserted as a substitute for a crystalline lens to correct near and/or far vision in patients with aphakia. The raw materials, basic form and principle of the multifocal mechanism are identical to those of the company's approved product, "Alcon Acrysof IQ Restor Single- Piece" (Approval No.: 22000BZX00970000). However, the diameter of apodized diffraction region, diffraction region number and central refractive region are different from the existing approved product. Domestic clinical study results were submitted to evaluate the efficacy and safety of the multifocal mechanism. |
| Mar 28, 2014 | Ahmed Glaucoma ValveIntraocular drain | Japan Focus Company, Ltd. | New device | Nov 12, 1993 | 244 mo later | 583 days | An artificial aqueous drainage device implanted to decrease intraocular pressure in patients with refractory glaucoma who have not responded to conventional therapy. It drains aqueous humor from the inside of the eye to decrease intraocular pressure. It consists of a silicone plate and tube, and a polypropylene valve system with silicone membrane sheet. The components include only an anterior chamber insertion type. A major differences from the original product “Baerveldt Glaucoma Implant (Approval No. 22300BZX00370000)” are that this product is smaller and has a valve system. A clinical evaluation report summarizing the results of literature search on overseas clinical studies and experience of this product was submitted to evaluate its safety and efficacy in decreasing intraocular pressure. |
| Mar 28, 2014 | Trevo Pro Clot RetrieverEmboli-removal catheter in the central circulatory system | Stryker Japan K.K. | New device | Not listed | — | 456 days | An emboli-removal catheter in the central circulatory system intended to restore blood flow by removing thrombus for patients with acute-phase cerebral infarction (generally, within 8 hours of symptom onset) who are ineligible for intravenous tissue plasminogen activator (t-PA) or who failed to restore blood flow with intravenous t-PA therapy. A clinical study was conducted to evaluate that safety and efficacy of this device substantially equal the existing approved device, “Merci retriever” (Approval No. 22200BZX00596000). |
| Mar 28, 2014 | Nipro Guiding Catheter BCoronary recanalization catheter | Nipro Corporation | New device | Not listed | — | 147 days | A coronary recanalization catheter providing back-up support for insertion of a therapeutic device. It is inserted into the coronary artery when it is difficult for a guidewire or an intravascular therapeutic device to reach a target lesion or pass a lesion in percutaneous transluminal coronary angioplasty. A clinical evaluation report was submitted to evaluate that the device has equal efficacy and safety to those of the approved devices. |
| Mar 28, 2014 | NAV 6 FilterEmboli-capturing catheter in the central circulatory system | Abbott Vascular Japan Co.,Ltd. | New device | Sep 11, 2008 | 66 mo later | 153 days | A device is used to prevent distal emboli by capture and removal of obstructing materials such as thrombi during carotid artery stent procedure. It is percutenously and temporarily placed in the distal sites from stenotic region in the cervical part of carotid artery. A clinical study was conducted to confirm the effectiveness and safety when this device is used during CAS. |
| Mar 26, 2014 | Protego Pro SImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 90 days | An implantable electrode lead with a screw-shaped tip having a quadrupolar connector (DF4-Standard). It is used for the treatment of ventricular tachycardia, with being connected to ICD or CRT-D. This lead, having one defibrillation electrode, was developed based on the main body of “Protego Pro SD (Approval No. 22500BZX00295A01).” The patients with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Mar 26, 2014 | Guidezilla Extension CatheterCoronary recanalization catheter | Boston Scientific Japan K.K. | New device | Mar 19, 2013 | 12 mo later | 129 days | A coronary recanalization catheter to enhance access to the stenotic site of the coronary artery and facilitate placement of interventional devices including a guidewire. A clinical evaluation report was submitted to evaluate that the device has equal efficacy and safety to those of the approved devices. |
| Mar 19, 2014 | Juvederm Vista UltraInjectable material to a soft tissue using hyaluronic acid | Allergan Japan KK | New device | Jun 2, 2006 | 94 mo later | 484 days | An injectable material into soft-tissue using hyaluronic acid. It is injected into the dermis to correct facial wrinkles and folds. Crosslinked and non-crosslinked hyaluronic acid, non-animal derived, obtained by fermentation of bacteria are mixed and filled into a syringe. Compared to the conventional injectable material using animal-derived collagen, the risk of allergy and infection was reduced. This product has different degrees of gel crosslinking from “Juvederm Vista Ultra Plus,” an application of which was submitted at the same time. This product is a softer injectable material. Foreign clinical study results were submitted to demonstrate its non- inferiority and safety compared to a control injectable material using collagen and safety. |
| Mar 19, 2014 | Juvederm Vista Ultra PlusInjectable material to a soft tissue using hyaluronic acid | Allergan Japan KK | New device | Jun 2, 2006 | 94 mo later | 484 days | An injectable material into soft tissue using hyaluronic acid. It is injected into the dermis to correct facial wrinkles and folds. Crosslinked and non-crosslinked hyaluronic acid, non-animal derived, obtained by fermentation of bacteria are mixed and filled into a syringe. Compared to the conventional injectable material using animal-derived collagen, the risk of allergy and infection was reduced. This product has different degrees of gel crosslinking from “Juvederm Vista Ultra,” an application of which was submitted at the same time. This product is a harder injectable material. Foreign clinical study results were submitted to demonstrate its non- inferiority and safety compared to a control injectable material using collagen and safety. |
| Mar 11, 2014 | Subcutaneous Implantable Lead SystemImplantable defibrillator/ pacemaker lead | Medtronic Japan Co., Ltd. | New device | Jun 11, 2001 | 153 mo later | 160 days | A subcutaneously implanted lead with a defibrillation coil electrode for ICD and CRT-D. This product is used for patients with a high defibrillation threshold in whom it is difficult for a normal transvenous defibrillation lead to work effectively. A clinical evaluation report summarizing results of foreign clinical studies was submitted to confirm the efficacy and safety of this device. |
| Mar 7, 2014 | INCEPTA Plus CRT-DImplantable biventricular pacing pulse generator with defibrillator function | Boston Scientific Japan K.K. | New device | Nov 17, 2011 | 28 mo later | 167 days | An implantable defibrillator with a biventricular pacing function. An application to add NYHA class II (mild) cardiac function to the current indications of class III (moderate) or IV (severe). A clinical study was conducted to evaluate the validity of the new indication. |
| Mar 7, 2014 | ELVeS Laser 1470Diode laser | Integral Corporation | New device | Not listed | — | 172 days | A laser treatment device used for varicose veins of lower extremities. It generates a laser in the veins to obstruct saphenous veins. A domestic clinical study was conducted to confirm that this device provides a similar degree of interruption of blood flow to the original product “ELVeS Laser” and that it is less associated with postoperative pains than the original. |
| Mar 3, 2014 | ICL KS-AquaPORTPhakic posterior chamber intraocular lens | STAAR Japan Inc. | New device | Not listed | — | 150 days | A one-piece intraocular lens to correct refractive errors. It is designed to be implanted in the posterior chamber of a phakic eye (in front of the human crystalline lens). A through-hole is added to the center of the optical zone of the company’s approved product “ICL (Approval No. 22200BZY00001000),” which makes laser iridotomy, required as a preoperative procedure in the original product, unnecessary. A clinical evaluation report was submitted to evaluate the effects on the change on visual function and corneal endothelial cells, and the presence or absence of increased ocular pressure associated with the absence of laser iridotomy. |
| Feb 28, 2014 | Coopdech i-CoolTemperature management system | Daiken Medical Co., Ltd. | New device | Not listed | — | 851 days | A system used to lower the brain temperature by bringing a cuff in which temperature-controlled physiological saline circulates into contact with parts of pharyngeal and esophagus of the patients who require therapeutic hypothermia following cardiac arrest. A domestic clinical study was conducted to confirm that brain temperature becomes lower early in therapeutic hypothermia by cooling pharyngeal with this device, that it does not worsen outcomes in the patients significantly, and that the risks are acceptable. |
| Feb 28, 2014 | Omnilink Elite Vascular StentStent for iliac artery | Abbott Vascular Japan Co.,Ltd. | New device | Jul 31, 2012 | 19 mo later | 76 days | A balloon-expanding stent and stent delivery system inserted and placed at the site of new lesions or restenotic lesions of symptomatic atherosclerosis in the iliac artery (common iliac artery and external iliac artery) to secure intravascular lumen. A clinical study was conducted to evaluate that the efficacy and safety of the product are not inferior compared to the results from past clinical studies. |
| Feb 28, 2014 | ATS 3f Aortic BioprosthesisEquine pericardial valve | Century Medical, Inc. | New device | Aug 30, 2008 | 66 mo later | 167 days | The ATS 3f Aortic Bioprosthesis is used for replacement as an alternative to dysfunctional aortic valve. Its leaflets are made of equine pericardium. This aortic bioprosthetic valve is designed as a tubular structure without a stent, which allows the valve to open and close like a native valve. A clinical study was conducted to confirm the efficacy and safety of this device when it was implanted in patients with aortic stenosis. |
| Feb 28, 2014 | FlosealGelatin-based local absorbable hemostatic material with human thrombin | Baxter Limited | New device | Jan 7, 2010 | 50 mo later | 270 days | A local absorbable hemostatic material used in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. A clinical study was conducted to evaluate its performance and safety for a bleeding area in cardiac, vascular and spine/spinal surgery. |
| Feb 28, 2014 | Cobalt G-HV Bone CementOrthopedic bone cement | At the time of approval, Biomet Japan, Inc.; currently, Biomet Japan, LLC | New device | Aug 3, 2005 | 103 mo later | 94 days | A device that gentamicin sulfate is added to the company’s approved orthopedic bone cement “Cobalt HV Bone Cement” as an antibacterial agent. It is used in the second stage of a two-stage revision prosthetic joint replacement associated with postoperative infection in a prosthetic joint replacement. A clinical evaluation report was submitted to demonstrate that the added antibacterial agent does not affect the efficacy and safety of the orthopedic bone cement. |
| Feb 24, 2014 | AERO Hybrid Stent for Airway StenosisTracheal stent | Sugan Co., Ltd. | New device | Not listed | — | 366 days | A tracheal stent used to secure an airway for tracheal or bronchial stenosis caused by malignant tumors. Since this stent made of nitinol is fully covered with polyurethane film, it has the advantage of both metal stent which can be inserted by rigid or flexible endoscope and silicon stent which has low complication rates in granulation, tumor infiltration and so on. A clinical study report was submitted to confirm the efficacy and safety of this device for tracheal and bronchial stenosis caused by malignant tumors. |
| Feb 19, 2014 | Freezor MAX Cryoablation CatheterCardiovascular ablation catheter | Medtronic Japan Co., Ltd. | New device | Dec 17, 2010 | 38 mo later | 300 days | A long, flexible, steerable catheter is used as an adjunctive device in the endocardial treatment of paroxysmal atrial fibrillation. This product is to be used in conjunction with “Arctic Front Advance Cardiac Cryoablation Catheter” (simultaneously submitted). It is used for gap cryoablation to complete electrical isolation of the pulmonary veins, cryoablation of focal trigger sites, or creation of an ablation line between the inferior vena cava and the tricuspid valve. A clinical study was conducted to evaluate the efficacy and safety of this product when it is applied for patients with drug- resistant recurrent symptomatic paroxysmal atrial fibrillation. [Priority review] |
| Feb 19, 2014 | Medtronic CryoConsoleVersatile cryosurgical unit | Medtronic Japan Co., Ltd. | New device | Dec 10, 2010 | 38 mo later | 300 days | A cryosurgical unit to be used for the treatment of arrhythmia. The device is for the exclusive use of Medtronic cryoablation catheters. A clinical study was conducted to evaluate the efficacy and safety of this product when it is applied for patients with drug- resistant recurrent symptomatic paroxysmal atrial fibrillation. [Priority review] |
| Feb 19, 2014 | Arctic Front Advance Cryoablation CatheterCardiovascular ablation catheter | Medtronic Japan Co., Ltd. | New device | Apr 12, 2012 | 22 mo later | 300 days | A balloon catheter used for cardiac cryoablation to treat drug-resistant recurrent symptomatic paroxysmal atrial fibrillation. A clinical study was conducted to evaluate the efficacy and safety of this product when it is applied for patients with drug-resistant recurrent symptomatic paroxysmal atrial fibrillation. [Priority review] |
| Feb 13, 2014 | Zimmer Delta Ceramic LinerArtificial hip joint, acetabular component | Zimmer K.K. | New device | Not listed | — | 159 days | An acetabular liner used for total hip replacement. It is made of zirconia-toughened alumina (BIOLOX delta) for improvement of its brittleness and abrasion property. It was developed to obtain a hip joint bearing with excellent abrasion characteristics and fracture strength by delta on delta in combination with the company’s artificial caput made of the same material. Domestic clinical study results were submitted to demonstrate that this device with the newly adopted material is not inferior to the approved prosthetic hip joint in the efficacy and safety. |
| Feb 6, 2014 | BA Soft Balloon CatheterIntravascular catheter for embolization of the central circulation system | Fuji Systems Corporation | New device | Not listed | — | 99 days | An intravascular catheter for embolization in the central circulation system used for a temporary interruption of blood flow in percutaneous intravascular surgery or as an adjunct of coil embolization for a cerebral aneurysm to prevent a coil body from protruding or being disengaged toward the parent artery. A clinical evaluation report was submitted to confirm the efficacy and safety of balloon-assisted coil embolization using this device. |
| Feb 4, 2014 | AbsolutePro Vascular StentStent for iliac artery | Abbott Vascular Japan Co.,Ltd. | New device | Feb 22, 2012 | 23 mo later | 112 days | A self-expanding stent and stent delivery system inserted and placed at the site of new lesions or restenotic lesions of symptomatic atherosclerosis in the iliac artery (common iliac artery and external iliac artery) to secure intravascular lumen. A clinical study was conducted to evaluate that the efficacy and safety of the product are not inferior compared to the results from past clinical studies. |
| Jan 30, 2014 | Kaneka Assistant Balloon Catheter NE-N3Intravascular catheter for embolization of the central circulation system | Kaneka Corporation | New device | Not listed | — | 192 days | A intravascular catheter for embolization in the central circulation system used for a temporary interruption of blood flow in percutaneous intravascular surgery or as an adjunct of coil embolization for cerebral aneurysm. A clinical evaluation report was submitted to confirm the efficacy and safety of balloon-assisted coil embolization using this device. |
| Jan 30, 2014 | J Graft Open Stent GraftAortic stent graft | Japan Lifeline Co., Ltd. | New device | Not listed | — | 419 days | An aortic open stent graft used for the treatment of diseases which require aorta replacement from the distal aortic arch to the proximal descending aorta. This product is capable of being fixed securely on the central side in a similar suturing way with a conventional synthetic graft, and is fixed on the peripheral side by the spring force of the stent graft without suture which provide one-stage, low invasive treatment for a widespread lesion. A clinical study was conducted to confirm the efficacy and safety of this device for diseases requiring aorta replacement. |
| Jan 28, 2014 | AB5000 VentricleSingle-use extracorporeal assistant artificial cardiac pump | Medix Japan, Inc. | New device | Sep 24, 2003 | 124 mo later | 401 days | An pneumatic ventricular support system that is placed external to the patient. A domestic clinical trial was conducted to evaluate its adaptability to domestic medical circumstances. Results of a post- marketing surveillance submitted to the US FDA were reviewed as reference data. |
| Jan 28, 2014 | Endovenous Closure SystemTherapeutic electrosurgical device | Covidien Japan Inc. | New device | Aug 1, 2006 | 90 mo later | 314 days | An electrosurgical device used for the treatment of primary varicose veins of lower extremities. It generates a laser in the veins to obstruct saphenous veins. It thermally coagulates the main saphenous vein to cause vascular obstruction. This device is composed of a generator which generates high- frequency current and a catheter which is connected to the generator. The catheter, to the tip of which a heating coil is attached, is inserted via the skin and lumina to an objective lesion region (the main saphenous vein). The heating coil obstructs a vascular vessel. A clinical study in which it is compared to the domestically approved product “ELVeS Laser (Approval No. 22200BZX00660000)” was conducted to evaluate its clinical efficacy and safety. |
| Jan 28, 2014 | R3 Delta Ceramic LinerArtificial hip joint, acetabular component | Smith & Nephew Orthopaedics KK | New device | Not listed | — | 62 days | An acetabular liner used for total hip replacement. It is made of zirconia-toughened alumina (BIOLOX delta) for improvement of its brittleness and abrasion property. It was developed to obtain a hip joint bearing with excellent abrasion characteristics and fracture strength by delta on delta in combination with a delta ceramic head made of the same material. A clinical evaluation report was submitted to confirm the performance of the bearing surface with the new material. |
| Jan 28, 2014 | Simplex P with TobramycinOrthopedic bone cement | Stryker Japan K.K. | New device | May 6, 2003 | 129 mo later | 123 days | The acrylic orthopedic bone cement used to fix a substitution material (artificial bone head, hip joint or knee joint) to an in vivo bone. One gram of tobramycin is sterilely added to the approved product “Surgical Simplex.” It is used in the second stage of a two-stage revision prosthetic joint replacement associated with postoperative infection in a prosthetic joint replacement. A clinical evaluation report was submitted to demonstrate that the added antibacterial agent does not affect the efficacy and safety of the orthopedic bone cement. |
| Jan 23, 2014 | Straumann Implant (SLActive) TLDental implant body | Straumann Japan K.K. | New device | Jun 30, 2004 | 115 mo later | 188 days | The first dental implant in Japan that enables earlier loading than conventional loading. This device is sealed into vial filled with normal saline to keep hydrophilic nature of titanium until just before use, which accelerates osteointegration. A domestic clinical study on an implant of 4.1mm in diameter was conducted to evaluate its efficacy and safety in early loading compared to in conventional loading. In addition, results of foreign clinical studies on a thinner implant of 3.3mm in diameter were submitted. |
| Jan 16, 2014 | Elmammo, Dedicated PET Scanner for Breast ImagingPositron emission tomography device for nuclear medicine diagnosis | Shimadzu Corporation | New device | Not listed | — | 100 days | A dedicated PET scanner for breast imaging to provide image information of distribution of a positron radioactive drug administered to patients within breasts by detecting exogenously with a gamma radiation detector. A clinical evaluation report was submitted to evaluate the effectiveness of images provided by this product in comparison to those by whole-body PET, contract-enhanced MRI and mammography. |
| Jan 15, 2014 | Alcon Acrysof IQ Restor Toric Single-PieceMultifocal posterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 227 days | A multifocal toric intraocular lens to be inserted into an aphakic eye with corneal astigmatism. This product has an aspheric, diffractive, and multifocal structure on the anterior optical surface and a toric structure on the posterior surface. The each optical design is identical to that of the company’s approved product. In addition, the raw material and basic structure of the lens are also identical to those of the company’s approved product. A domestic clinical study was conducted to evaluate that this device corrects corneal astigmatism and provides adequate multifocal function, compared to clinical study results of the approved single-function lenses of multifocal or toric. |
| Jan 14, 2014 | HOYA iSert Micro ToricPosterior chamber lenses with an injector | HOYA Corporation | New device | Not listed | — | 141 days | A posterior chamber lens with an injector in which a monofocal posterior chamber lens is preloaded to insert it into an aphakic eye with corneal astigmatism after cataract surgery. The raw materials of the lens are the same as those of “HOYA iSert Micro (Approval No. 22200BZX00615000).” A cylindrical power is newly added to one side of the lens to correct corneal astigmatism, which is the difference from the existing approved product. A domestic clinical study was conducted to evaluate the clinical efficacy and safety of this lens with the newly added correcting function of corneal astigmatism. |
| Jan 14, 2014 | FinefluxHemodiafilter | Nipro Corporation | New device | Not listed | — | 162 days | A hollow fiber membrane hemodiafilter used to remove fluid and uremic substances stored in the body due to uremia. It is indicated for patients whose renal function has been markedly reduced due to chronic or acute renal failure, etc. Cellulose triacetate, which has been conventionally used as a hollow fiber membrane raw material of a hemodialyzer, is adopted as a hollow fiber membrane raw material of the hemodiafilter. A clinical study was conducted to evaluate the efficacy and safety because the raw material of its semipermeable membrane was proved to be not equivalent to that of the approved product. |
| Dec 25, 2013 | SonicWeld Rx SystemAbsorbable plate for internal fixation | Nippon Martin K.K. | New device | Not listed | — | 75 days | A device consisting of a plate and a pin used in a bone junction or reconstruction of cranio-maxillo- facial bone or bone fragment fixation in bone transplantation to cranio-maxillo-facial bone, and an ultrasonic fixator to fix them. The pin and the plate are made of polylactic acid which is absorbed into the body. This product has a characteristic that its ultrasonic fixator generates vibrating energy, which melts and hardens the pin in the bone hole to fix the plate. A clinical evaluation report was submitted to evaluate that the fixation performance and safety with this absorbable material are equivalent to those of similar products. |
| Dec 20, 2013 | HOYA CTROphthalmic intracapsular ring | HOYA Corporation | New device | Not listed | — | 255 days | A blue C-shaped polymethyl methacrylate open ring used for patients whose cataract surgery is expected to carry risks associated with its completion and to be difficult to perform due to a brittleness or rupture of Zinn's Zonule. The ring, inserted into a capsule of crystalline lens, holds the capsule during surgery by making the subluxated capsule produce an extension from the inside. Shape of the ring is a single or a multiple circle. The multiple-circle ring has one or two sewing hooks which is used for anchoring to the sclera by suture thread. The hook is designed to come out from the anterior capsule and a suture thread which passes through the hook is anchored to the sclera. A clinical evaluation report was submitted to confirm that efficacy and safety of this device are equivalent to foreign similar devices, based on domestic and overseas long-term usage histories of the foreign similar devices of which indication and operative procedure had already been established. [Priority review] |
| Dec 20, 2013 | Solitaire FR Revascularization DeviceEmboli-removal catheter in the central circulatory system | Covidien Japan, Inc. | New device | Mar 2, 2012 | 22 mo later | 424 days | A multi-cell retriever intended to restore blood flow by removing thrombus for patients in acute phase of ischemic cerebral infarction who are ineligible for intravenous t-PA or who failed to restore blood flow with intravenous t-PA therapy. A clinical study was conducted to evaluate that safety and efficacy of this device substantially equal to the existing approved devices. |
| Dec 12, 2013 | Laminoplasty Basket Plate SetInternal fixation plate | Ammtec Inc. | New device | Not listed | — | 256 days | An internal fixation plate used for fixing severed bone parts after spinal decompression for spinal cord compression. It is fixed to the space of vertebral lamina removed in laminoplasty by a screw. In addition, an implanted bone is able to be filled into the basket portion. A clinical evaluation report based on literature research on usual laminoplasty and use results of the approved product used in the surgery was submitted to demonstrate that the fixation performance and safety of this product are equivalent to the approved product. |
| Dec 6, 2013 | GuideLiner CatheterCoronary recanalization catheter | Japan Lifeline Co., Ltd. | New device | Dec 1, 2011 | 24 mo later | 380 days | A coronary recanalization catheter providing back-up support for insertion of the therapeutic device. It is inserted into the coronary artery when it is difficult for a guidewire or an intravascular therapeutic device to reach a target lesion or pass a lesion in percutaneous transluminal coronary angioplasty. A clinical evaluation report was submitted to confirm the efficacy and safety when this device is used as a slave catheter. |
| Dec 6, 2013 | Visceral Fat Meter EW-FA90Body constituent analysis instrument | Panasonic Corporation | New device | Not listed | — | 118 days | A body component analyzer consisting of an apparatus body, a measuring belt for abdomen, and pads. The cross section area of visceral fat estimated by a unique calculating formula based on abdominal impedance and the measured value of abdominal circumference is displayed on the apparatus body. A clinical study was conducted to evaluate the correlation between the cross section area of visceral fat by CT tomogram of the abdomen and an estimated value by this product and its screening performance (sensitivity and specificity). |
| Nov 29, 2013 | Ingenio MRIImplantable cardiac pacemaker | Boston Scientific Japan K.K. | New device | Not listed | — | 410 days | An implantable cardiac pacemaker connected with electrodes placed within the heart. The patients implanted with the device can conditionally undergo MRI scans. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Nov 22, 2013 | Wingspan stentCerebral artery stent | Stryker Japan K.K. | New device | Aug 3, 2005 | 100 mo later | 434 days | A self-expanding cerebral artery stent used in patients who have a dissection of the vessel or acute or impending occlusion caused by failure in percutaneous angioplasty for intracranial arterial stenosis with balloon angioplasty catheter or who require the re-treatment with no other effective treatment option. A domestic clinical study was conducted in patients with drug- resistant transient ischemic attack or cerebral apoplexy caused by intracranial artery stenosis to evaluate the safety and performance under domestic medical environments. [Priority review] |
| Nov 22, 2013 | Jarvik 2000 Implantable Ventricular Assist DeviceImplantable ventricular assist device | Century Medical, Inc. | New device | Not listed | — | 1390 days | An axial-flow implantable ventricular assist device system to be used to improve the blood circulation until heart transplant is performed in patients who have severe cardiac failure for which heart transplant is indicated, show continuous decompensation in spite of drug therapy or circulation assist techniques, such as an external ventricular assist system, and for whom it is considered difficult to survive without heart transplant. A clinical study was conducted in the U.S. to evaluate the efficacy and safety of this product, and a domestic clinical study was conducted to evaluate the efficacy and safety in Japan where healthcare environments are different from those in the U.S. [Orphan device] |
| Oct 30, 2013 | Trabecular Metal Reverse Shoulder SystemTotal shoulder prosthesis | Zimmer K.K. | New device | Dec 19, 2005 | 94 mo later | 1038 days | A total shoulder prosthesis having the concept of a reversed shoulder prosthesis system in which the anatomical structure is reversed. It is used for cases of having difficulty in elevetion of a shoulder with an unreconstructible rotator cuff function such as a massive rotator cuff tear. When it can not be used in reversed combination for the reason that a base plate can not be applied during surgery, it can be emergently combined in an anatomical shape. Trabecular metal is applied to portions contacting bone on a humeral stem and a reversed base plate. A clinical evaluation report was submitted to confirm the efficacy and safety of this device is equivalent to the existing approved devices based on overseas usage histories and publications of this device and similar devices. (The original product is in a reexamination period) |
| Oct 11, 2013 | Natrelle 410 Breast ImplantGel-filled mammary prosthesis | Allergan Japan K. K. | New device | Feb 20, 2013 | 8 mo later | 416 days | A gel-filled artificial breast for restoring or forming the shape of a breast after the insertion into the application site. It is used for breast reconstruction surgery or augmentation mammaplasty. It is improved compared with the approved "Natrelle Breast Implant (Approval No. 22400BZX00354000)”.The improvements are that it is designed with an anatomical shape that mirrors a woman’s real breast and the gel with increased degree of crosslinking makes the breast harder. A clinical study was conducted to evaluate the performance as an artificial breast and adverse events in breast reconstruction surgery or augmentation mammaplasty. (The original product is in a reexamination period) |
| Sep 30, 2013 | Libra Single 8 NeurostimulatorElectrical brain stimulation device for tremor | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 536 days | A deep brain stimulation device is indicated for patients with essential tremor, various symptoms of Parkinson's disease or dystonia that have not responded sufficiently to drug therapy. This product is used for alleviation of essential tremor, movement disorders associated with Parkinson’s disease, and dystonia symptoms. A clinical study was conducted to evaluate the efficacy and safety of this product for Parkinson’s disease and dystonia. (The original product is in a reexamination period) |
| Sep 30, 2013 | Brio Dual 8 NeurostimulatorElectrical brain stimulation device for tremor | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 536 days | A deep brain stimulation device is indicated for patients with essential tremor, various symptoms of Parkinson's disease or dystonia that have not responded sufficiently to drug therapy. This product is used for alleviation of essential tremor, movement disorders associated with Parkinson’s disease, and dystonia symptoms. A main body of implantable stimulator is rechargeable. A clinical study was conducted to evaluate the efficacy and safety of this product for Parkinson’s disease and dystonia. (The original product is in a reexamination period) |
| Sep 30, 2013 | DBS 4 contacts leadElectrical brain stimulation device for tremor | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 382 days | An electrode lead placed on the deep brain in deep brain stimulation therapy. It transmits electric stimulus generated from an implanted stimulation device. The product consists of an electrode lead and its accessories. It is used in conjunction with “Libra Single 8 Neurostimulator (Approval No. 22500BZX00450000)” and “Brio Dual 8 Neurostimulator (Approval No. 22500BZX00451000).” A clinical study was conducted to evaluate the efficacy and safety of product in Parkinson’s disease and dystonia. |
| Sep 27, 2013 | GORE CTAG Thoracic EndoprosthesisAortic stent graft | W.L. GORE & Associates, Co., Ltd. | New device | Aug 23, 2011 | 25 mo later | 254 days | An aortic stent graft system used for endovascular treatment of thoracic aortic aneurysm. The product consists of a stent graft and delivery catheter. The main differences from the approved product “GORE TAG Thoracic Endoprosthesis (Approval No. 22000BZX00185000)” include a shape change of the stent graft (removal of flare parts at both ends of a stent graft), an increase in the stent wire diameter, a change of the apex number of the stent, an addition of a new stent graft size, and a position change of adhesive tape, etc. These changes enhanced compression resistance of the stent graft and followability to an implanted vessel so that the product is applicable to more diversified blood vessel diameters. A clinical study was conducted to evaluate its efficacy and safety in cases with thoracic aortic aneurysm. |
| Sep 27, 2013 | Mepilex Ag ( Mölnlycke Health Care K.K.Antibacterial wound dressing and protecting material | Mölnlycke Health Care K.K. | New device | Jan 25, 2007 | 80 mo later | 346 days | A wound dressing and protecting material used to "protect wound" reaching subcutaneous adipose tissue (except for third degree burns), "maintain a moist environment," "promote healing," and "relieve pain." It is used for wounds with exudate fluid which have a high possibility of infection. The product consists of a silicone gel-coated hydrophilic polyurethane foam containing silver and a vapor- permeable polyurethane film. A clinical evaluation report based on foreign use-results and published literature of this product and similar products was submitted to confirm if silver contained in the product causes no problem such as protracted wound healing. |
| Sep 24, 2013 | Versajet IIHydraulic knife | Smith & Nephew Wound Management KK | New device | Aug 1, 2011 | 26 mo later | 197 days | A device to be used for wound debridement (acute wounds, chronic wounds and burn wounds), soft tissue debridement and operative wound cleaning with waterjet. Improvement in connectivity between the hand piece and the console and water resistance of the console was provided to enhance the operability of the approved product “Versajet S (Approval No. 22400BZX00233000)”. A non-clinical study demonstrated the performance equality between both products. A clinical study was conducted to confirm the efficacy and safety of debridement. |
| Sep 20, 2013 | MED-EL EAS Hearing Implant SystemCochlear implant system | MED-EL Elektro-Medizinische Gerä te GmbH | New device | Not listed | — | 245 days | A cochlear implant system for perceiving information such as supporting hearing by acoustic stimulation to the low-frequencies and electric stimulation to the high- frequencies in patients with ski-slope hearing loss, in which there is good hearing for lower frequencies who have not responded sufficiently to wearing hearing aids. This product consists of an audio processor (an audio signal processing device) and an implant (an electrode and a stimulator). Of the sound signals picked up by the microphone embedded the audio processor, the high- frequency sounds are perceived by electric stimulation generated from the electrode in the same way as an existing cochlear implant, while the low-frequency sounds are amplified to be perceived by acoustic stimulation through the ear canal. A clinical study was conducted to evaluate the efficacy and safety of this product in patients with ski-slope hearing loss. [Priority review] |
| Sep 20, 2013 | PD Laser BTPDT semiconductor laser | Panasonic Healthcare Co., Ltd. | New device | Not listed | — | 266 days | A laser irradiation device designed for photodynamic therapy. This device is to be used in combination with “Laserphyrin 100mg for Injection” (Approval No. 21500AMZ00509000) as an oncotropic photo- sensitizer, targeting primary malignant brain tumor as an additional treatment to the surgical resection. A clinical trial was conducted to confirm the efficacy and safety of photodynamic therapy for primary malignant brain tumor using this device and the concomitant drug. [Orphan medical device] |
| Sep 20, 2013 | InterStim II Neurostimulator for Sacral NeuromodulationImplantable stimulator for bladder and bowel control | Medtronic Japan Co., Ltd. | New device | Mar 14, 2011 | 30 mo later | 386 days | An implantable nerve stimulation system to improve fecal incontinence by electrical stimulation to sacral nerves for the patients with fecal incontinence who have not responded or cannot apply to conservative treatment. Clinical studies were conducted to evaluate therapeutic effect of this device for fecal incontinence and the safety during a test stimulation period and an implantation period. |
| Sep 20, 2013 | Aequalis Reversed Shoulder ProsthesisTotal shoulder prosthesis | Tornier S.A.S. | New device | May 14, 2004 | 112 mo later | 756 days | A reversed shoulder prosthesis system in a reversed form of the conventional, anatomically-structured shoulder prosthesis with a spherical glenoid component and a humeral head component that is a concave hemispherical shell. Since there was no similar device in Japan, a clinical evaluation report was submitted to confirm the efficacy and safety of this device equivalent to similar devices based on overseas usage history and publications of this device and the similar devices by taking into account that the indication and operative procedure had already been established by its long- term usage history overseas. |
| Sep 17, 2013 | Hydrosite Gentle AgAntibacterial wound dressing and protecting material | Smith & Nephew Wound Management KK | New device | Apr 3, 2009 | 53 mo later | 529 days | An antibacterial wound dressing and protecting material containing sulfadiazine silver as an antibacterial ingredient added to the absorption pad layer of the approved product “Hydrosite AD Gentle (Approval No. 22100BZX00942000).” It is used for wounds with exudate fluid which have a high possibility of infection. Foreign clinical study results on a similar product which has a different adhesive agent on a wound contact layer were submitted to confirm if the antibacterial ingredient causes no problems such as protracted wound healing. |
| Sep 17, 2013 | Hydrosite AgAntibacterial wound dressing and protecting material | Smith & Nephew Wound Management KK | New device | Apr 3, 2009 | 53 mo later | 529 days | An antibacterial wound dressing and protecting material containing sulfadiazine silver as an antibacterial ingredient added to the absorption pad layer of the approved product “Hydrosite Plus (Approval No. 22100BZX01097000).” In addition, soft gel is applied to the wound contact surface of the approved product to improve the operability. It is used for wounds with exudate fluid which have a high possibility of infection. Foreign clinical study results on a similar product which has a different adhesive agent on a wound contact layer were submitted to confirm if the antibacterial ingredient causes no problems such as protracted wound healing. |
| Sep 12, 2013 | Viva Quad CRT-D SeriesImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd. | New device | Not listed | — | 172 days | An implantable defibrillator with a biventricular pacing function. One of the IS-1 connector ports of the original product “Viva CRT-D Series (Approval No. 22500BZX00320000)” is changed to a IS4 connector port capable of being adopted to a left ventricle (LV) lead that has four independent pacing electrodes. There are three models of the products having different mounting functions. It also has VectorExpress, a support function to be used for selecting a pacing vector, which provides automatic measurement of the capture threshold based on impedance and pulse width of 16 types of LV vector and relative battery life. A clinical study was conducted to evaluate the efficacy and safety of AdaptivCRT technology. |
| Sep 12, 2013 | Prismaflex STSlow continuous hemofilter | Gambro K.K. | New device | Not listed | — | 164 days | A slow continuous hemofilter to improve clinical conditions by performing continuous hemodiafiltration. It is used in patients with severe sepsis or septic shock, patients with acute renal failure accompanying diseases or conditions including sepsis, multi organ failure, acute hepatic failure, acute respiratory failure, acute cardiovascular failure, acute pancreatitis, burn injury, traumatic injury, postoperative diseases or patients with chronic renal failure who have unstable circulation dynamics associated with these diseases or conditions. This product is a filter used for slow continuous hemofiltation that is connected to a blood circuit. The main difference from the approved product “Hemofeel SH (Approval No. 21200BZZ00274000)” is that the product is indicated for patients with severe sepsis or septic shock. A clinical study was conducted to evaluate the efficacy and safety of this device in patients with severe sepsis or septic shock. |
| Sep 12, 2013 | SepXirisSlow continuous hemofilter | Gambro K.K. | New device | Not listed | — | 164 days | A slow continuous hemofilter to improve clinical conditions by performing continuous hemodiafiltration. It is used in patients with severe sepsis or septic shock, patients with acute renal failure accompanying diseases or conditions including sepsis, multi organ failure, acute hepatic failure, acute respiratory failure, acute cardiovascular failure, acute pancreatitis, burn injury, traumatic injury, postoperative diseases or patients with chronic renal failure who have unstable circulation dynamics associated with the diseases or conditions. The main difference from the approved product “Hemofeel SH (Approval No. 21200BZZ00274000)” is that the product is indicated for patients with severe sepsis or septic shock. A clinical study was conducted to evaluate the efficacy and safety of this device in patients with severe sepsis or septic shock. |
| Sep 6, 2013 | Adler BIOLOX delta Ceramic SystemTotal hip prosthesis | Robert Reid Inc. | New device | Not listed | — | 107 days | A femoral stem-head and an acetabulum-forming liner made of alumina-zirconia ceramics composite used in hip replacement used in combination with the approved products “Alder prosthetic hip joint system (Approval No. 22500BZX00017000),” “HYDRA Femoral Component (Approval No. 22500BZX00018000),” and “BIOLOX delta Ceramic Head (Approval No. 22500BZX00019000).” Because combination of the company’s head and liner made of the raw material was unprecedented, a clinical evaluation report evaluating the incidence of repeat replacements and the incidence of defects based on foreign use results and published literature was submitted. |
| Sep 6, 2013 | GRYPHON BR AnchorAbsorbable ligament anchor | Johnson & Johnson K.K. | New device | Mar 11, 2009 | 54 mo later | 138 days | A suture anchor used to fix soft tissues such as ligaments in a shoulder, foot/ankle, elbow, hip to a bone. The product consists of an absorbable anchor, partially absorbable sutures, and an inserter. The point of improvement is that a complex of glycolic acid-lactic acid polyester and β-tricalcium phosphate which is unprecedented in Japan, is adopted as a raw material of the anchor. A clinical study was conducted to confirm the efficacy and safety of this product with the newly adopted absorbable material. |
| Sep 6, 2013 | HEALIX ADVANCE BR AnchorAbsorbable ligament anchor | Johnson & Johnson K.K. | New device | Feb 29, 2012 | 18 mo later | 140 days | A suture anchor to fix a rotator cuff to a bone. The product consists of an absorbable anchor, partially absorbable sutures, and an inserter. The point of improvement is that a complex of glycolic acid-lactic acid polyester and β-tricalcium phosphate of which a remaining period is shorter than that of a poly-L- lactic acid anchor, is adopted as a raw material. Clinical study results using anchors of the same raw material as that of this product were submitted to confirm that failure caused by the material does not occur. |
| Sep 6, 2013 | MILAGRO Interference ScrewAbsorbable ligament anchor | Johnson & Johnson K.K. | New device | Mar 31, 2004 | 113 mo later | 103 days | An interference screw used to fix soft tissue to a bone. The point of improvement is that a complex of glycolic acid-lactic acid polyester and β-tricalcium phosphate of which a remaining period is shorter than that of a poly-L-lactic acid anchor, is adopted as a raw material. Clinical study results using anchors of the same raw material as that of this product were submitted to confirm that failure caused by the material does not occur. |
| Aug 27, 2013 | Evia HF-T ProImplantable biventricular pacing pulse generator without defibrillator function | Biotronik Japan, Inc. | New device | Not listed | — | 419 days | An implantable biventricular pacing pulse generator without a defibrillator function intended for the treatment of bradycardia. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Aug 27, 2013 | Tecnis Toric 1-PiecePosterior chamber lens | AMO Japan K.K. | New device | Apr 15, 2013 | 4 mo later | 207 days | A one-piece monofocal posterior chamber lens to be inserted into an aphakic eye after cataract surgery accompanied with corneal astigmatism. The same raw materials as those of “Tecnis one-piece (Approval No. 22000BZX01610000)” are used. A cylindrical frequency was newly added to the front of the lens to correct corneal astigmatism, which is difference from the existing approved product. A clinical study was conducted to evaluate the clinical efficacy and safety of this product with the newly added correcting function of corneal astigmatism. |
| Aug 9, 2013 | Watch PATSleep evaluation device | Philips Respironics GK | New device | Aug 14, 2008 | 60 mo later | 280 days | A medical device used as an adjunct in evaluation and diagnosis of sleep-disordered breathing events and sleep stages in patients suspected of sleep- disordered breathing. The wrist-worn device records PAT (Peripheral Artery Tonometry) signal (finger plethysmogram ), Sp0 , snoring, and body position 2 and motion during sleep. Results from clinical studies on the precedent device equipped with the same software as this device were submitted to examine whether the software of this device can evaluate sleep disorder. |
| Aug 9, 2013 | CranioFix AbsorbableAbsorbable cranial fixation clamp | B. Braun Aesculap Japan Co., Ltd. | New device | Mar 31, 2004 | 112 mo later | 220 days | An implantable cranial fixation device composed of two absorbable discs, of which are made of polyester [Poly (L-lactide-co-D, L-lactide) 70:30], and a non-absorbable suture to fix them. It is used to fix a free bone flap during closing of the cranium in a craniotomy. This device has the following points as differences from the approved devices: (1) The device offers a more simple operation of cranial fixation in a shorter time because operation to heat and shape a plate and exclusive tools became unnecessary; (2) It also has no artifact in postoperative MRI or CT images; (3) The absorbable material causes no problems of impeding growth of bones in children or its moving and it is not necessary to be removed at the time of repeat surgery. Clinical studies were conducted to confirm the efficacy and safety of this product with the newly adopted absorbable material. |
| Jul 23, 2013 | SeQuent Please Drug Eluting Balloon CatheterBalloon-dilating catheter for coronary angioplasty | Nipro Corporation | New device | Not listed | — | 400 days | The first balloon-dilating catheter for coronary angioplasty with a paclitaxel-coated balloon in Japan to inhibit restenosis during revascularization for restenotic lesion in coronary artery stent. A clinical study was conducted to evaluate the efficacy and safety of this product for coronary in-stent restenosis. |
| Jul 23, 2013 | LifeVest Wearable DefibrillatorWearable defibrillator | ZOLL Lifecor Corporation | New device | Aug 17, 2009 | 47 mo later | 287 days | The first wearable defibrillator in Japan to monitor and analyze electrocardiograms of the patients wearing this device continuously, and to deliver electric shock for defibrillation automatically if ventricular tachycardia or ventricular fibrillation requiring defibrillation is detected. A clinical study was conducted to evaluate the success rate of defibrillation for arrhythmia which requires defibrillation and the risk of inappropriate electric shock delivery due to false detection of arrhythmia. [Priority review] |
| Jul 19, 2013 | Gore Propaten Vascular GraftArtificial blood vessel using heparin | W.L. GORE & Associates, Co., Ltd. | New device | Nov 9, 2006 | 80 mo later | 389 days | An artificial blood vessel used in vascular replacement, bypass grafting, hemodialysis or other vascular techniques for patients with occlusive diseases or aneurysms or trauma patients who require vascular replacement. It has a basic structure of a stretched polytetrafluoroethylene (PTFE) tube. Heparin bonded covalently to the luminal surface of the graft is expected to produce a local and long-term antithrombotic effect and improve the 1-year patency rate and limb salvage rate after peripheral vascular bypass surgery for patients with peripheral artery occlusive disease. A clinical study was conducted to evaluate its efficacy and safety in above-knee femoropopliteal artery bypass surgery for vascular occlusive diseases. |
| Jul 18, 2013 | Viva CRT-D SeriesImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd. | New device | Jan 29, 2013 | 6 mo later | 193 days | An implantable defibrillator with a biventricular pacing function. The device is newly equipped with AdaptivCRT technology developed to automatically control CRT parameters (AV and VV delays) based on patients' conduction and CardioSync Optimization supporting CRT parameter control by measuring patients' electric conduction property at follow-up visits, with which the approved product “Protecta XT CRT-D (Approval No. 22200BZX00913000)” was equipped. There are six models of the products having different shapes of connectors of lead connection parts and different mounting functions. A clinical study was conducted to evaluate the efficacy and safety of the AdaptivCRT function. |
| Jul 11, 2013 | PillCam COLON 2 Capsule Endoscopy SystemCapsule electronic endoscope system | Given Imaging K.K. | New device | Not listed | — | 172 days | A capsule electronic endoscope system to take images of colorectal mucosa and provide the images when colonoscopy is required for diagnosis of colonic diseases but it is difficult to be performed. The main difference from the approved product “Given Capsule Endoscopy (Approval No. 22100BZX00363000)” is that this product is used for diagnosis of colonic diseases. A clinical study was conducted to evaluate the sensitivity of this device in subjects who were detected by colonoscopy to have diseases which require endoscopic or surgical therapy. |
| Jul 10, 2013 | XIENCE Xpedition Drug Eluting StentCoronary stent | Abbott Vascular Japan Co.,Ltd. | New device | Dec 21, 2012 | 7 mo later | 233 days | A coronary stent composed of a drug-eluting stent used for treatment of patients with symptomatic ischemic heart diseases who have a new coronary lesion (a lesion length of 32mm or less) with a reference vessel diameter of 2.50-3.75mm and a delivery catheter used to implant a stent to the coronary stenosis site. The device has a different stent delivery system from the company's approved product “XIENCE PRIME Drug Eluting Stent (Approval No. 22400BZX00145000).” A new stent diameter of 3.25mm is added. Results from clinical studies on “XIENCE PRIME Drug Eluting Stent” were submitted to confirm the efficacy and safety of this product. |
| Jul 3, 2013 | Niti-S Comvi Pyloric/Duodenal stentGastroduodenal stent | Century Medical, Inc. | New device | Not listed | — | 115 days | A gastroduodenal stent for patients with unresectable malignant gastroduodenal stenosis who cannot be managed by palliative surgical therapy and are not expected to achieve improvement with other treatments. The main difference from the approved product “Niti-S Gastroduodenal Stent (Approval No. 22300BZX00428000)” is that this product has a cover made of PTFE. A clinical study report was submitted summarizing results of literature research on clinical data to evaluate the efficacy and safety of this device compared to an uncovered stent. |
| Jul 2, 2013 | Lumax 740 ICD ProAutomatic implantable defibrillator | Biotronik Japan, Inc. | New device | Not listed | — | 449 days | An automatic implantable defibrillator intended for the treatment of ventricular tachycardia or ventricular fibrillation. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Linox Smart Pro SImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 449 days | An implantable defibrillator/pacemaker lead. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Linox Smart Pro SDImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 449 days | An implantable defibrillator/pacemaker lead. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Linox Smart Pro S DXImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 449 days | An implantable defibrillator/pacemaker lead. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Lumax 740 CRT-D ProImplantable biventricular pacing pulse generator with defibrillator function | Biotronik Japan, Inc. | New device | Not listed | — | 364 days | An implantable biventricular pacing pulse generator with a defibrillator function intended for the treatment of ventricular tachycardia. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Corox Pro OTW BPImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 364 days | An implantable defibrillator/pacemaker lead. The patients implanted with the device can conditionally undergo an MRI scan. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Ilest 7 ICD ProAutomatic implantable defibrillator | Biotronik Japan, Inc. | New device | Not listed | — | 197 days | An automatic implantable defibrillator intended for the treatment of ventricular tachycardia or ventricular fibrillation. This product was developed based on the approved product “Lumax 740 ICD” (Approval No.22400BZX00162000). The major improvements from the approved product include downsizing of the product, a newly added automatic threshold monitoring function in the right atrium, and MRI compatibility under specific conditions. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Ilesto 7 CRT-D ProImplantable biventricular pacing pulse generator with defibrillator function | Biotronik Japan, Inc. | New device | Not listed | — | 189 days | An Implantable biventricular pacing pulse generator with a defibrillator function intended for the treatment of ventricular tachycardia. This product was developed based on the approved product “Lumax 740 CRT-D” (Approval No.22400BZX00161000). The major improvements from the approved product include downsizing of the product, a newly added automatic threshold monitoring function in the right atrium, and MRI compatibility under specific conditions. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Ilest 7 ICD DF4 ProAutomatic implantable defibrillator | Biotronik Japan, Inc. | New device | Not listed | — | 189 days | An automatic implantable defibrillator intended for the treatment of ventricular tachycardia or ventricular fibrillation. This product was developed based on the approved product “Lumax 740 ICD” (Approval No.22400BZX00162000). The major improvements from the approved product include downsizing of the product, a newly added automatic threshold monitoring function in the right atrium, MRI compatibility under specific conditions, and an equipped DF4 connector port. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Linox Smart Pro DF4 SDImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 189 days | An implantable defibrillator/pacemaker lead. This product was developed based on the company's approved product “Linox Smart SD” (Approval No.22200BZX00751000). The major modifications from the approved product include a change to the DF4 connector port and the MRI compatibility under specific conditions. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jul 2, 2013 | Protego Pro SDImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 81 days | An implantable defibrillator/pacemaker lead. The patients implanted with the device can conditionally undergo an MRI scan. An application for additional brand name for “Linox Smart Pro DF4 SD”. (The original product is in a reexamination period) |
| Jun 26, 2013 | Resolute Integrity SV Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Feb 17, 2012 | 16 mo later | 425 days | A stent system for percutaneous coronary stent placement consisting of a stent to be inserted and placed at the site of a lesion to maintain the vascular lumen and a delivery catheter used to deliver the stent to the site of the lesion. The stent is coated with zotarolimus with a cytostatic effect to topically inhibit neointimal proliferation that is thought to be a cause of in-stent restenosis. A clinical study was conducted to evaluate the efficacy and safety of this product. (The original product is in a reexamination period) |
| Jun 24, 2013 | Solia JTEndocardial implantable pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 222 days | An endocardial implantable pacemaker lead connected with an implantable cardiac pacemaker. The patients implanted with the device can conditionally undergo an MRI scan. This device was newly applied as a pacemaker lead which is compatible with MRI. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jun 21, 2013 | EmbosphereProsthetic material for embolization in vessels of the central circulation system | Nippon Kayaku Co., Ltd. | New device | Not listed | — | 478 days | Embosphere is a microbead for arterial embolization. It is hydrophilic, non-absorbable, and biocompatible spherical particles, which are impregnated and coated with porcine-derived gelatin to acrylic copolymers. A clinical study was conducted to evaluate the efficacy and safety of this product for patients with hypervascular tumor and arteriovenous malformation. |
| Jun 21, 2013 | HepasphereProsthetic material for embolization in vessels of the central circulation system | Nippon Kayaku Co., Ltd. | New device | Nov 7, 2006 | 79 mo later | 357 days | Hepasphere is a microbead for arterial embolization. It is biocompatible, hydrophilic, non-bioabsorbable, swellable, compressible, and deformable spherical particles composed of vinyl alcohol/sodium acrylate copolymers. A clinical study was conducted to evaluate the efficacy and safety of this product for patients with hypervascular tumor and arteriovenous malformation. |
| Jun 21, 2013 | Sapien XTTranscatheter bovine pericardial valve | Edwards Lifescience Corporation | New device | Not listed | — | 455 days | A prosthetic heart valve (balloon expandable bovine pericardial valve) system is used for transcatheter valve implantation for patients with severe symptomatic aortic stenosis attributed to sclerosis and degeneration of the cusp of native aortic valve, for whom surgery cannot be performed and receiving the treatment with this product is considered the best treatment. A clinical study was conducted to evaluate the efficacy and safety of this product and to ensure the feasibility of the procedure. |
| Jun 21, 2013 | Magnetic Stimulator TMU-1100Magnetic stimulation device for treatment of urinary incontinence | Nihon Kohden Corporation | New device | Not listed | — | 396 days | A magnetic stimulation device to improve symptoms of overactive bladder with urinary incontinence. This product is used for adult female patients with overactive bladder who are not responsive to or cannot use therapeutic agents for urinary incontinence. Pulse current flowing in a stimulation coil under the sealing surface of a chair-shaped stimulation unit generates magnetic energy through the upper portion of the sealing surface. The variable magnetic fields induce eddy currents in the body of the patient who is seated on the stimulation unit. The eddy currents primarily stimulate the nerves in the pelvic floor area of the patient. A clinical study was conducted to evaluate the efficacy and safety of this product in female patients with overactive bladder with urinary incontinence. |
| Jun 12, 2013 | Biomet Biolox Delta Ceramic LinerArtificial hip joint, acetabular component | At the time of approval, Biomet Japan, Inc.; currently, Biomet Japan, LLC | New device | Not listed | — | 260 days | A liner made of zirconia-toughened alumina ceramic composites used in combination with the company’s approved product “Biomet Biolox Delta Ceramic Head (Approval No. 22400BZX00141000).” Because the combination of the company’s liner material and head material was an unprecedented combination, a clinical evaluation report summarizing its efficacy and safety based on foreign use results and published literature was submitted. |
| Jun 7, 2013 | Tendril MRIImplantable defibrillator/pacem aker lead | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 557 days | An implantable defibrillator/pacemaker lead used for long-term the heart rhythm regulation by cardiac stimulation in combination with an implantable cardiac pacemaker, etc. The patients implanted with the device can undergo an MRI scan under specific conditions. A clinical evaluation report summarizing the results of the foreign clinical studies of this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jun 7, 2013 | Accent MRIImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 557 days | An implantable cardiac pacemaker to regulate the heart rhythm by cardiac stimulation for a long term. The patients implanted with the device can undergo an MRI scan under specific conditions. A clinical evaluation report summarizing the results of the foreign clinical studies of this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jun 7, 2013 | Accent MRI RFImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 557 days | An implantable cardiac pacemaker to regulate the heart rhythm by cardiac stimulation for a long term. The patients implanted with the device can undergo an MRI scan under specific conditions. A clinical evaluation report summarizing the results of the foreign clinical studies of this product was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Jun 7, 2013 | Nuance MRIImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 74 days | Application for addition of brand name to "Accent MRI" (Approval No. 22500BZX00241000). (The original product is in a reexamination period) |
| Jun 7, 2013 | Nuance MRI RFImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 74 days | Application for addition of brand name to "Accent MRI RF" (Approval No. 22500BZX00242000). (The original product is in a reexamination period) |
| Jun 7, 2013 | Tendril MRI JImplantable defibrillator/pacem aker lead | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 74 days | Application for addition of brand name to "Tendril MRI" (Approval No. 22500BZX00240000). (The original product is in a reexamination period) |
| Jun 5, 2013 | PEPA Hemodiafilter GDFHemodiafilter | Nikkiso Co., Ltd. | New device | Not listed | — | 114 days | A hollow fiber membrane hemodiafilter used to remove fluid and uremic substances stored in the body due to uremia. It is indicated for patients whose renal function has been markedly reduced due to chronic or acute renal failure, etc. Because equivalence to the approved haemodiafiltration device was not demonstrated with regard to the semipermeable membrane material, a clinical study was conducted to confirm the efficacy and safety. |
| May 21, 2013 | Niti-S Colorectal StentColonic stent | Century Medical, Inc. | New device | Not listed | — | 142 days | A biliary stent used to relieve obstructive symptoms before surgery for stricture of the large intestine caused by malignant tumors or for palliation in patients with unresectable malignant tumors or who are not expected to respond to other treatments. A clinical study report, which summarizes literature information using technical success of stent placement, improvement of obstructive symptoms after the placement, and the incidence of adverse events as evaluation items, was submitted to confirm the efficacy and safety of this device when it is used for relief of obstructive symptoms before surgery or palliation. |
| May 1, 2013 | SMART CONTROL StentStent for iliac artery | Johnson & Johnson K.K. | New device | Nov 7, 2012 | 6 mo later | 418 days | A device that is identical to the approved product Smart Stent for Iliac Artery (Approval No.21700BZY00247000). A stent system consisting of a self-expanding nickel-titanium alloy stent used for bail-out treatment (for acute or impending occlusion caused by failure in intervention therapy) and a delivery system to deliver the stent to the site of the lesion, for the treatment of stenosis or occlusion of the vessels in the superficial femoral artery region in addition to the treatment of iliac artery which is the applicable scope of the approved product. A clinical study was conducted to evaluate the efficacy and safety of this product for bail- out treatment. (The original product is in a reexamination period) |
| May 1, 2013 | SMART stentStent for blood vessel | Johnson & Johnson K.K. | New device | Nov 7, 2012 | 6 mo later | 418 days | A stent system consisting of a self-expanding nickel- titanium alloy stent used for bail-out treatment (for acute or impending occlusion caused by failure in intervention therapy) and a delivery system to deliver the stent to the site of the lesion, for the treatment of stenosis or occlusion of the vessels in the superficial femoral artery region. A clinical study was conducted to evaluate the efficacy and safety of this product for bail- out treatment. (The original product is in a reexamination period) |
| Apr 12, 2013 | DC BeadProsthetic material for embolization in vessels of the central circulation system | Eisai Co., Ltd. | New device | Dec 16, 2002 | 124 mo later | 848 days | A hydrophilic microsphere (spherical particulate) composed of polyvinyl alcohol polymer with a bridged structure. This product is used in transcatheter arterial embolization for patients with hepatocellular carcinoma. A clinical study was conducted to evaluate the efficacy and safety of the transcatheter arterial chemoembolization using this product for patients with unresectable hepatocellular carcinoma. |
| Apr 12, 2013 | HistoacrylProsthetic material for embolization in vessels | B. Braun Aesculap Japan Co., Ltd. | New device | Not listed | — | 197 days | An n-butyl-2-cyanoacrylate is injected for endoscopic vascular embolization for gastric varices. This product has been already used in and out of Japan as material for endoscopic vascular embolization. Based on the current situation, a clinical evaluation report was submitted to evaluate the efficacy and safety of this product. [Priority review] |
| Apr 8, 2013 | Biotrue OnedaySingle-use colored contact lens for correcting visual acuity | B.L.J. Company, Ltd. | New device | Jun 5, 2012 | 10 mo later | 141 days | A single use soft contact lens with 78% water content and oxygen permeability (Dk) of 42 composed of nesofilcon A. It is integrally colored light blue and contains an ultraviolet absorber. Because the product has novel raw materials, but not a novel design, a clinical study was conducted to evaluate the efficacy and safety of wearing this product for correction of visual acuity. |
| Mar 29, 2013 | AMPLATZER Vascular Plug IIProsthetic material for embolization in vessels of the central circulation system | St. Jude Medical Japan Co., Ltd. | New device | Jun 18, 2007 | 69 mo later | 499 days | A prosthetic material for embolization in vessels consisted of a self-expandable plug with a nitinol mesh wire of a cylindrical form, a push wire to send the plug to a target site, and a loader that stores the plug in the expanded state. It blocks a blood vessel by being percutaneously inserted and placed in the arteries and veins except blood vessels in the heart and the skull, and reduces, blocks or alters the blood flow. A major difference from the approved "AMPLATZER Vascular Plug" (Approval No. 22400BZX00361000) is a change in the plug shape from a simple cylindrical shape to a shape composed of three cylindrical blocks. The change intends to shorten the time for vascular occlusion by creating many barriers against the blood flow and adding size variations. Results from Japanese clinical studies using the approved product were submitted to evaluate the efficacy and safety of this product in patients with occlusion of vascular lesions, patients indicated for alternation of blood flow, and patients indicated for hemostasis of hemorrhagic lesions. (The original product is in a reexamination period) |
| Mar 29, 2013 | Relay Plus Thoracic Stent Graft SystemAortic stent graft | Japan Lifeline Co., Ltd. | New device | Sep 21, 2012 | 6 mo later | 407 days | This product consists of a stent graft and delivery system used for endovascular treatment of descending thoracic aortic aneurysm. The two covered stent rings at the proximal end of the stent graft are free from a spiral support wire, which allows independent bending at the proximal end. The placement position of the stent graft can be adjusted by keeping a bare stent on the proximal end with a holder at the tip in the delivery system. A clinical study was conducted to evaluate the efficacy and safety of this product for the treatment of descending thoracic aortic aneurysm in comparison with a control group treated with surgical procedures. |
| Mar 29, 2013 | Pinnacle Ceramic Liner (CERAMAX)Artificial hip joint, acetabular component | Johnson & Johnson K.K. | New device | Dec 23, 2010 | 27 mo later | 273 days | A liner that costitutes an acetabular component used in total hip replacement. The major improvement is its raw material, an Alumina-Zirconia ceramic matrix composites (BIOLOX delta) that has better intensity than the conventional ceramic material. Used in combination with the company's artificial femoral head made by the same raw material, this product composes a ceramic-on-ceramic system. A clinical study was conducted to evaluate the usability and safety of this product in clinical use. |
| Mar 28, 2013 | Niox MinoNitric oxide analysis instrument | Chest M.I., Inc. | New device | Mar 3, 2008 | 61 mo later | 1554 days | A measuring instrument used to measure the level of nitric oxide, used as a biomarker of eosinophic inflammation, in the expired air. In a clinical study, the measuring performance for the concentration of nitric oxide is evaluated on equivalence to predicate devices outside Japan, and the changes in the concentration of nitric oxide was compared before and after the treatment of inflammation. |
| Mar 22, 2013 | SerescueProsthetic material for embolization in vessels of the central circulation system | Astellas Pharma Inc. | New device | Not listed | — | 493 days | A porous gelatin sponge plate was developed as a vascular embolization material. Users cut this plate to an appropriate size using the sterilized medical knife, medical scissors, etc. with consideration of the vascular diameter of the site to be applied, suspend it with an appropriate amount of a contrast medium, and deliver it to the site in the blood vessel via a catheter to block the blood flow or to support forming an embolus. In this way, the hemostatic effect is expected for bleeding to which direct pressure cannot be applied from the body surface. A clinical evaluation report summarizing the results of literature searches on the efficacy and safety of transcatheter hemostasis using a gelatin sponge equivalent to this product was submitted. |
| Mar 22, 2013 | NaviStar RMT ThermoCoolCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Jan 4, 2008 | 63 mo later | 451 days | An electrode catheter for the radiofrequency catheter ablation and for the electrophysiological study; it is used to treat symptomatic drug refractory paroxysmal and persistent atrial fibrillation, atrial flutter and ventricular tachycardia which is not treated effectively by other ways. This device is manipulated with "Magnetic Navigation System Niobe" (Approval No. 22500BZX00103000). It also has an irrigation system that flows with saline from an irrigation hole at the tip electrode. The clinical study was conducted to evaluate the efficacy and safety of manipulating it by the Magnetic Navigation System Niobe. |
| Mar 22, 2013 | NaviStar RMTCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Jan 26, 2006 | 86 mo later | 451 days | An electrode catheter for the radiofrequency catheter ablation and for the electrophysiological study; it is used to treat supraventricular tachycardia. This device is manipulated with "Magnetic Navigation System Niobe" (Approval No. 22500BZX00103000). The clinical study was conducted to evaluate the efficacy and safety of manipulating it by the Magnetic Navigation System Niobe. |
| Mar 22, 2013 | Nerve Regeneration Guidance Conduit NerbridgeCollagen- containing absorbable nerve regeneration inducing material | Toyobo Co., Ltd. | New device | Not listed | — | 387 days | A polyglycolic acid conduit filled with sponge-like collagen which is inserted into defects of the peripheral nerves that have been ruptured or broken because of injuries, etc. in order to induce regeneration of the nerve and reconstruct the function by bridging both ends of nerve. A prospective clinical study was conducted to evaluate the efficacy and safety of this product in patients with peripheral nerve defect on the distal wrist. |
| Mar 22, 2013 | Magnetic Navigation System NiobeCardiac Mapping System Workstation | Siemens Japan K.K. | New device | Jan 15, 2003 | 122 mo later | 451 days | A guiding system that navigates "NaviStar RMT ThermoCool" (Approval No. 22500BZX00104000) or "NaviStar RMT" (Approval No. 22500BZX00107000), both of which are exclusive catheters to this system, to a target region in intervention procedures. Clinical studies were conducted to evaluate the efficacy and safety of manipulating these exclusive catheters with this device. |
| Mar 7, 2013 | XIENCE PRIME SV Drug- eluting Coronary Stent SystemCoronary stent | Abbott Vascular Japan Co., Ltd. | New device | Nov 1, 2011 | 16 mo later | 463 days | A drug-eluting stent coated with everolimus to inhibit the neointimal proliferation and a delivery catheter. This product is used for elective cases in patients with symptomatic ischemic heart diseases due to de novo lesions in native coronary arteries with a reference vessel diameter of 2.25-2.50 mm. Clinical studies were conducted to evaluate the efficacy and safety of this product for small vascular lesions. (The original product is in a reexamination period) |
| Feb 22, 2013 | FastViewIntravascular optical tomographic catheter | Terumo Corporation | New device | Not listed | — | 231 days | An intravascular optical coherence tomographic (OCT) catheter to conduct OCT of the coronary artery; it is connected to "Lunawave" (Approval No. 22500BZX00058000), an OCT image diagnosis equipment for exclusive use with this catheter. The broadband near-infrared light guided from the exclusive equipment is irradiated toward the circumferential direction from near the tip of the catheter. Then, the reflected from the vessel interferes with the reference light, and the interference signal is generated. This equipment obtains the cross-sectional images of blood vessels by Fourier-transforming the interference signal. A clinical evaluation report was submitted to evaluate the efficacy and safety of this equipment in clinical use. |
| Feb 19, 2013 | Evia T Series ProImplantable cardiac pacemaker | Biotronik Japan, Inc. | New device | Not listed | — | 419 days | An implantable cardiac pacemaker connected with electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. This device was newly applied as an implantable cardiac pacemaker which is compatible with MRI. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Feb 19, 2013 | Evia Series ProImplantable cardiac pacemaker | Biotronik Japan, Inc. | New device | Not listed | — | 419 days | An implantable cardiac pacemaker connected with electrodes placed within the heart. The patients implanted with the device can conditionally undergo an MRI scan. This device was newly applied as an implantable cardiac pacemaker which is compatible with MRI. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Feb 19, 2013 | Solia SEndocardial implantable pacemaker leads | Biotronik Japan, Inc. | New device | Not listed | — | 419 days | An endocardial implantable pacemaker lead connected with an implantable cardiac pacemaker. The patients implanted with the device can conditionally undergo an MRI scan. This device was newly applied as a pacemaker lead which is compatible with MRI. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Feb 19, 2013 | Solia TEndocardial implantable pacemaker leads | Biotronik Japan, Inc. | New device | Not listed | — | 419 days | An endocardial implantable pacemaker lead connected with an implantable cardiac pacemaker. The patients implanted with the device can conditionally undergo an MRI scan. This device was newly applied as a pacemaker lead which is compatible with MRI. A clinical evaluation report was submitted to evaluate the safety of this device in MRI scans. (The original product is in a reexamination period) |
| Feb 19, 2013 | Double-balloon Endoscopy SystemBalloon-guided small-intestine endoscopy system | Fujifilm Corporation | New device | Not listed | — | 358 days | A system that inserts an endoscope deep inside of the small intestine by using the technique to fold the intestinal tract with the combination of the endoscope, an over-tube with a balloon, a balloon to be attached to the endoscope and a balloon controller. A clinical study was conducted to verify the capability of this system to reach deep inside of the small intestine with the technique to fold the small intestine and to ensure the safety of the system. |
| Feb 14, 2013 | Geistlich Bio-GideAbsorbent periodontal tissue regeneration material | Geistlich Pharma AG | New device | Jun 11, 1997 | 188 mo later | 637 days | An absorbent material using collagen derived from porcine membrane (originated in Switzerland) as a raw material. It is used in combination with autologous bone or bone substitute in guided (periodontal) tissue regeneration (GTR) for a defective part of the alveolar bone as a protective membrane against epithelial migration to new bone. A clinical study was conducted to evaluate the efficacy and safety of the combined use of this product with a dental bone substitute. |
| Jan 28, 2013 | Bronchial Blocker EWSBronchial blocker | Harada Corporation | New device | Not listed | — | 374 days | A silicone resin bronchial blocker that is used to fill the bronchi and close fistula in patients who have refractory and inoperable, secondary pneumothorax, prolonged airleak following pneumectomy or other fistula. Clinical studies were conducted to evaluate the efficacy and safety of this product for the target diseases. [Orphan device] |
| Jan 28, 2013 | Adler Hip Prosthesis SystemTotal hip prosthesis | Robert Reid Inc. | New device | Not listed | — | 581 days | This product consists of a press-fit fixed stem, modular neck and head which are used on the femoral side and a cup and liner which are used on the acetabular side to replace the hip function in total hip replacement. Aluminum oxide (alumina) is adopted for the liner and head to improve the resistance to abrasion and toughness of the bearing surface, while the acetabular cup surface has a porous structure by layering technique to improve the synostosis. Since there have been concerns about a risk of breakage caused by a new raw material of alumina, a clinical evaluation report that evaluated the incidence of repeat replacement when this product was used for total hip replacement was submitted. |
| Jan 28, 2013 | BIOLOX Delta Ceramic HeadHemi hip prosthesis | Robert Reid Inc. | New device | Not listed | — | 356 days | An artificial head prosthesis used to replace the hip function on the femoral side in total hip replacement. The raw material, shape and structure of this product are equivalent to those of the approved product "BIOLOX Delta Ceramic Femoral Head" (Approval No. 22300BZX00018000). A major difference is the acetabular liner, which is used in combination with this product, made of aluminum oxide (alumina). A clinical evaluation report that evaluated the incidence of repeat replacement, incidence of defects, etc. when this product and the alumina-made acetabular liner were used together was submitted. |
| Dec 27, 2012 | Kawasumi Najuta Thoracic Stent Graft SystemAortic stent graft | Kawasumi Laboratories, Incorporated | New device | Not listed | — | 505 days | This product consists of a stent graft and delivery system used for endovascular treatment of thoracic aortic aneurysm. For the product, 64 kinds of stent skeletons are set up as basic shapes by making differences in stent length, curvature, and torsion angle in order for it to fit the site and shape of the aorta where the product is placed. A straight-type or a tapered-type graft is sutured and fixed in accordance with the diastolic diameter of this stent skeleton, and fenestration is present or absent in a graft; and therefore there are 952 patterns of stent grafts depending on the combination. A clinical study was conducted to evaluate the efficacy and safety in the treatment of thoracic aortic aneurysm. |
| Dec 27, 2012 | Epic Vascular StentStent for iliac artery | Boston Scientific Japan K.K. | New device | Apr 13, 2012 | 8 mo later | 302 days | This product consists of a self-expandable stent made of nickel-titanium alloy and its delivery system. The stent is transdermally inserted and placed in a blood vessel to maintain or expand the vascular lumen for the treatment of symptomatic vascular disease in the iliac artery such as stenotic lesion. The stent has a tandem structure, including closed cells at both ends and an open cell at the center in order to reduce a position gap when it is expanded. Clinical studies were conducted to confirm the efficacy and safety of this product for the treatment of symptomatic vascular disease in the iliac artery. |
| Dec 26, 2012 | Four SeasonsReusable colored contact lenses for correcting visual acuity | Menicon Co., Ltd. | New device | Not listed | — | 512 days | Reusable colored contact lenses for correcting visual acuity. The lens is indicated for daily wear and replaced in three-month intervals. A silicon-containing material which has oxygen transmissibility equivalent to or greater than the approved "Menicon Tinu" (Approval No. 21800BZZ10125000) is used for this product. The combination of major component monomers in the raw material has novelty, and a clinical study was conducted to evaluate the efficacy and safety of wearing this product for correction of visual acuity. |
| Dec 26, 2012 | HOYA Vivinex iSertPosterior chamber lenses with an injector | HOYA Corporation | New device | Not listed | — | 348 days | A posterior chamber lens with an injector, for which single focus posterior chamber lens that is inserted into the aphakic eye after cataract surgery is preloaded in an injector. With the haptics and the optics made of the same raw material, it has a casting one-piece structure. A major difference from the approved "HOYA iSert Micro (Approval No. 22200BZX00615000) is a change in the raw material of the posterior chamber lens to reduce the risk of capsule opacification. The raw material has novelty, and a clinical study was conducted to evaluate the optical efficacy and safety of this product in clinical use. |
| Dec 21, 2012 | Osteoraptor HA AnchorAbsorbable ligament anchor | Smith & Nephew Endoscopy K.K. | New device | Nov 3, 2008 | 50 mo later | 360 days | This product consists of absorbable anchors made of poly-L-lactic acid and hydroxyapatite, suture and inserter. Multiple anchors are implanted in the bone to secure them to the bone by surgically suturing damaged, ruptured or exfoliated soft tissues such as tendons, ligaments or muscles. The point of improvement is that hydroxyapatite was mixed to poly- L-lactic acid, which is an absorbable material of the existing product. A clinical study was conducted to confirm the efficacy and safety of the aforementioned purpose and usage of this new absorbable material. |
| Dec 20, 2012 | CENTERPIECE OD Plate SystemFixation device placed in the spine | Medtronic Sofamor Danek Co., Ltd. | New device | Jun 6, 2005 | 90 mo later | 869 days | A fixation device placed in the spine. This product is used for laminectomy to maintain the location of the vertebral arch which is dilated from the lower cervical spine to the upper thoracic spine (C3 to Th3). It is used for the treatment of cervical spine diseases such as spondylitic myelopathy and ossification of posterior longitudinal ligament, spinal cord tumor, etc. It consists of a cervical spine plate and a cervical spine screw. While one-side open laminectomy is performed for the existing therapy using a titanium plate in the same way with this product, the form structure has been improved for this product to optimize the surgical technique. Since there is no other product with the similar form and structure, a clinical evaluation report was submitted to confirm the efficacy and safety of the surgical technique with this product. |
| Dec 5, 2012 | MisagoStent for blood vessel | Terumo Corporation | New device | Not listed | — | 433 days | A stent system consisting of a self-expanding nickel- titanium alloy stent used for bail-out treatment (for acute or impending occlusion caused by failure in percutaneous angioplasty) and a delivery system to deliver the stent to the site of the lesion, for the treatment of symptomatic arterial diseases in the superficial femoral artery region. A clinical study was conducted to evaluate the efficacy and safety in bail- out treatment for stenosis or occlusion of the superficial femoral artery. (The original product is in a reexamination period) |
| Dec 5, 2012 | SNaP Negative Pressure Wound Therapy SystemSingle-use negative pressure wound therapy system | Century Medical, Inc. | New device | Aug 7, 2009 | 40 mo later | 344 days | A negative pressure wound therapy system to promote wound healing by adding the controlled negative- pressure, protecting wounds, promoting granulation of the wound, and removing exudative fluid and infectious waste materials for patients with refractory wounds who have not responded to existing treatments or are considered not to be responding. This product is a portable device for single use and can be used for outpatients. Thus, a clinical study was conducted to evaluate the efficacy and safety of this product in outpatients. |
| Nov 29, 2012 | Implantable ventricular assist device HeartMate IIImplantable ventricular assist device | Thoratec Corporation | New device | Apr 21, 2008 | 55 mo later | 513 days | The first axial-flow implantable ventricular assist device system in Japan to be used to improve the blood circulation until heart transplant is performed in patients who have severe cardiac failure for which heart transplant is indicated, show continuous decompensation in spite of drug therapy or circulation assist techniques, such as the use of an external ventricular assist system, and for whom it is considered difficult to survive without heart transplant. A clinical study was conducted in the US to evaluate the efficacy and safety of this product, and a domestic clinical study was conducted to evaluate the efficacy and safety in Japan where healthcare environments are different from those in the US. |
| Nov 29, 2012 | CapSure Sense MRI LeadEndocardial implantable pacemaker leads | Medtronic Japan Co., Ltd. | New device | Not listed | — | 139 days | An endocardial implantable pacemaker lead used by connecting them to an implantable cardiac pacemaker. The patients implanted the device can conditionally undergo an MRI scan. Efficacy and safety evaluations of this product were performed based on the results of overseas clinical studies of the original product "CapSure FIX MRI Lead (approval No.: 22400BZX00132000)." (The original product is in a reexamination period) |
| Nov 27, 2012 | MitroflowBovine pericardial valve | Sorin Biomedica Cardio S.r.l. | New device | Oct 23, 2007 | 61 mo later | 1246 days | A bovine pericardial valve used to replace the aortic valve which has become dysfunctional due to disease, etc. Unlike the existing product, this product has a valve leaflet outside the stent frame. A clinical study was conducted to confirm that the efficacy and safety of this product in target patients are within the assumed range. |
| Nov 21, 2012 | Active Articulation E1Artificial hip joint, acetabular component | Biomet Japan, Inc. | New device | Jan 14, 2011 | 22 mo later | 601 days | An acetabular liner used for hip replacement. It is used in combination with an acetabular cup and a femoral stem head. It is a dual-mobility system that has bearing surfaces both inside and outside the product. This double-mobility system enables increase of the range of motion and enhances the implant stability. It is made of ultra high molecular weight polyethylene which was given cross-linking treatment to enhance the resistance to abrasion, and was immersed in vitamin E to enhance the resistance to oxygen. A clinical evaluation report was submitted to evaluate the efficacy and safety of the dual-mobility structure. |
| Oct 30, 2012 | Dailies Total 1Single-use colored contact lenses for correcting visual acuity | Ciba Vision Corporation | New device | Mar 30, 2012 | 7 mo later | 246 days | Single-use tinted contact lenses for correcting visual acuity. The silicone hydrogel lens is indicated for daily wear. The product has high oxygen transmissibility and uses a new material called Delefilcon A to improve the quality. The raw material has novelty, and a clinical study was conducted to evaluate the efficacy and safety of wearing this product for correction of visual acuity. |
| Oct 30, 2012 | NRG RF Transseptal NeedleTransseptal needle | Japan Lifeline Co., Ltd. | New device | May 28, 2008 | 53 mo later | 193 days | A transseptal needle with an electrode to be used to create a puncture in interatrial septum in order to insert a catheter, etc. from the right atrium to the left atrium. The atrial septum is punctured by the tissue causarization with high-frequency energy generated from a dedicated high-frequency generator. In contrast to conventional transseptal needles, this device can puncture using high-frequency energy. A clinical evaluation report summarizing the clinical data of literature was submitted to evaluate the efficacy and safety of this product in comparison with conventional transseptal needles. |
| Oct 30, 2012 | Medtronic Reveal XTImplantable data recorder for electrocardiogra m | Medtronic Japan Co., Ltd. | New device | Nov 21, 2007 | 59 mo later | 181 days | An implantable electrocardiogram recorder, subcutaneously implanted to continuously monitor the electrocardiogram. This device detects, records and stores wave patterns of atrial fibrillation, and sends the information recorded in this product to a server through the approved "Medtronic CareLink Monitor" (Approval No. 21900BZX00664000); the functions are the major improvements from the approved device "Medtronic Reveal DX" (Approval No. 22000BZX01025000). A clinical evaluation report was submitted to evaluate that this product can detect atrial fibrillation. |
| Oct 18, 2012 | da Vinci Si Surgical SystemSurgical robot, operation unit | Intuitive Surgical Inc. | New device | Feb 18, 2009 | 44 mo later | 385 days | A device to assist the surgeon's manipulation of endoscopic surgical devices when endoscopic surgery is performed in areas of general digestive surgery, thoracic surgery (except cardiac surgery), urology, and gynecology. Improvement from the original product "da Vinci Surgical System (approval No.: 22100BZX01049000)" includes downsizing of the surgeon consoles and enabling setting of the position of movement according to the needs of the surgeon. In addition, as a secondary function, two surgeons can manipulate the device, when two surgeon consoles are connected. Results of clinical studies using the original product were submitted to explain the extrapolability to efficacy and safety evaluation of this product. (The original product is in a reexamination period) |
| Sep 28, 2012 | Neuroform StentProsthetic material for embolization in vessels of the central circulation system | Stryker Japan K.K. | New device | May 27, 2010 | 28 mo later | 470 days | An intracranial artery stent (for treatment of cerebral aneurysm) used to prevent coil migration in coil embolization for wide-necked cerebral aneurysm. "Codman Enterprise VRD (Approval No. 22200BZX00078000)", an already-approved similar medical device, has a stent with a closed cell structure, but this product is characterized by a stent with an open cell structure. Clinical studies were conducted to evaluate the efficacy and safety of this product for patients with wide-necked cerebral aneurysm. (The original product is in a reexamination period) |
| Sep 28, 2012 | AMPLATZER Vascular PlugProsthetic material for embolization in vessels of the central circulation system | St. Jude Medical Japan Co., Ltd. | New device | Sep 9, 2003 | 109 mo later | 458 days | A prosthetic material to promote vascular embolization which is used to occlude blood vessels and reduce, block, or alter blood flow by inserting and placing it transdermally in arteries/veins, except blood vessels in the heart and the skull. Clinical studies were conducted to confirm the efficacy and safety of this product for occlusion of vascular lesions, alteration of blood flow, and hemostasis for hemorrhagic lesions. |
| Sep 28, 2012 | Natrelle Breast ImplantGel-filled mammary prosthesis | Allergan Japan K. K. | New device | Nov 17, 2006 | 70 mo later | 2080 days | A gel-filled breast in which silicone gel is filled in a shell made of silicone elastomer which repairs or forms the shape of a breast after insertion into the application site. It is used for breast reconstruction surgery or augmentation mammaplasty. Clinical studies were conducted to evaluate the efficacy and safety of this product when used for breast reconstruction surgery, augmentation mammaplasty, and revision surgery. |
| Sep 28, 2012 | Contegra Pulmonary Valved ConduitArtificial blood vessel with a bovine-derived valve | Medtronic Japan Co., Ltd. | New device | Nov 21, 2003 | 106 mo later | 1652 days | A conduit with a pulmonary valve made of bovine jugular veins which is used to repair/reconstruct the right ventricular outflow tract leading to the pulmonary arteries from the heart. A clinical study was conducted to evaluate the efficacy and safety of this product in children (aged under 18 years) with abnormality of the right ventricular outflow tract or functional failure of an already-implanted homograft, etc. |
| Sep 28, 2012 | KanameCoronary stent | Terumo Corporation | New device | Not listed | — | 277 days | A cobalt-chromium alloy coronary stent which is used for the treatment of patients with symptomatic ischemic disease (including the treatment of acute or threatened coronary artery closure as a result of unsuccessful intervention) whose reference vessel diameter is in the range of 3.0 mm to 4.0 mm and who have new or restenosis coronary lesion (length of lesion up to 25 mm). Clinical studies were conducted to confirm the efficacy and safety of this product for the treatment of symptomatic ischemic disease. |
| Sep 28, 2012 | Restoration ADMArtificial hip joint, acetabular component | Stryker Japan K.K. | New device | Oct 18, 2007 | 59 mo later | 161 days | This product consists of an acetabular cup and an acetabular insert used for hip replacement. The inner side of the acetabular insert is located on the femoral stem head, while the external side forms a bearing surface with the acetabular cup. This product was developed to increase the range of motion for the artificial hip prosthesis by the two bearing surfaces (dual-mobility) of the acetabular insert and to enhance the stability of the prosthesis because dislocation of the hip requires severer displacement of the femoral head in the vertical direction. A clinical evaluation report was submitted to evaluate the treatment outcome of the artificial hip prosthesis with the dual- mobility structure. |
| Sep 28, 2012 | Natrelle 133 Tissue ExpanderSkin tissue expander | Allergan Japan K.K. | New device | Jul 23, 1986 | 314 mo later | 1642 days | A device to be temporary implanted under the breast subcutaneous tissue or the pectoralis major muscle to facilitate placement of artificial breast in which purpose is to expand/extend the skin and tissues surrounding the breast prior to breast reconstruction surgery. A clinical evaluation report was submitted to confirm that the insertion of a round-type breast implant is possible after skin/tissue expansion using this product in breast reconstruction surgery. |
| Sep 19, 2012 | Nerve Regeneration Guidance Conduit NerbridgeCollagen- containing absorbable nerve regeneration inducing material | Toyobo Co., Ltd. | New device | Not listed | — | 1267 days | A femoral component of artificial hip prosthesis used for reconstruction of joint function in patients with femur head necrosis and coxarthrosis. While the shape and structure of this product are the same as those of the approved product, this product uses different raw materials for the compression bolt and cortical crew. A clinical evaluation report was submitted to confirm the efficacy and safety of hip replacement and bipolar hip arthroplasty using this product. |
| Sep 7, 2012 | Cook Postpartum BalloonUterine balloon | Cook Japan Inc. | New device | Apr 17, 2002 | 125 mo later | 1036 days | A balloon used to relieve or stop uterine bleeding after delivery. There is no product that specializes in such intended use in Japan. Considering the fact that pressure hemostasis using a balloon such as this product is common in and out of Japan, a clinical evaluation report was submitted to evaluate the efficacy and safety of this product. |
| Sep 6, 2012 | Promus Element Plus Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Jun 1, 2012 | 3 mo later | 385 days | A drug-eluting stent coated with everolimus to inhibit the neointimal proliferation and a delivery catheter. The stent with a diameter of 2.25 mm included in this product is the first coronary stent in Japan which is used for elective cases in patients with symptomatic ischemic heart diseases due to de novo lesions in native coronary arteries with a reference vessel diameter of 2.25-2.50 mm. Clinical studies were conducted to confirm the efficacy and safety of this product for small vascular lesions. |
| Jul 31, 2012 | RENASYS Wound Therapy SystemNegative pressure wound therapy system | Smith & Nephew Wound Management K.K. | New device | Feb 25, 2009 | 41 mo later | 319 days | A negative pressure wound therapy system to promote wound healing by maintaining a local negative- pressure environment, protecting wounds, and removing exudative fluid, infectious material, etc. for patients with refractory wounds who have not responded to existing treatments or are considered to not be responding. Clinical studies were conducted to evaluate the efficacy and safety of this product for acute, subacute, and chronic refractory wounds. (The original product is in a reexamination period) |
| Jul 27, 2012 | MOMA UltraEmboli-capturing catheter in the central circulatory system | Medtronic Japan Co., Ltd. | New device | Oct 15, 2009 | 33 mo later | 854 days | A device to prevent distal emboli, which is used for capture and removal of obstructing materials such as thrombi during percutaneous carotid artery stenting with dilatation of 2 balloons to occlude the common carotid artery and external carotid artery. Clinical studies were conducted by using the pre-improvement product to confirm the efficacy and safety of this product for patients at a high surgical risk of complications of carotid artery endarterectomy. |
| Jul 27, 2012 | JaccHuman autologous cells and tissue | Japan Tissue Engineering Co., Ltd. | New device | Not listed | — | 1068 days | An autologous cultured cartilage to alleviate clinical symptoms by implanting it in the affected site of traumatic cartilage deficiency and osteochondritis dissecans (excluding knee osteoarthritis) in knee joints with a cartilage defective area of 4 cm2 or more for which there are no other treatment options. Chondrocytes isolated from the non-load-bearing site of a knee joint of patients by taking a small amount of cartilage tissue are three-dimensionally cultured in atelocollagen gel to obtain this product. Clinical studies were conducted to evaluate the efficacy and safety of this product for patients with traumatic cartilage deficiency, osteochondritis dissecans, and knee osteoarthritis. |
| Jul 27, 2012 | Bipolar RFA System CelonPOWERRadiofrequency ablation system | Olympus Medical Systems Corporation | New device | Not listed | — | 872 days | A device to be used to coagulate a malignant tumor of the liver with radiofrequency current. While the approved product is a monopolar system, this product is a bipolar system with two electrodes for one applicator. It also has a mode to energize up to 6 electrodes (15 pairs) sequentially by simultaneous puncture of up to 3 applicators. A clinical study was conducted to evaluate the necrogenic effect and safety of this product for hepatic malignancy. |
| Jul 26, 2012 | Linox Smart S DXImplantable defibrillator/ pacemaker lead | Biotronik Japan, Inc. | New device | Not listed | — | 848 days | A screw-type electrode lead that is used to conduct atrial sensing, ventricular sensing/pacing, anti- trancycardia pacing treatment and defibrillation with one lead. It consists of 1 defibrillation electrode, 3 ring electrodes and 1 screw electrode. A clinical evaluation report was submitted to evaluate that defibrillation is properly achieved when this product is used in clinical practice. |
| Jul 24, 2012 | PEM Flex Solo II PET ScannerPositron emission tomography device for nuclear medicine diagnosis | Sceti K.K. | New device | Mar 31, 2009 | 40 mo later | 589 days | A positron CT device for nuclear medicine diagnosis; it images distribution of the pre-dosed radioactive agent that releases positive electrons in the breast. The breast is sandwiched by a tray with built-in gamma-ray scanner and the distribution of a radioactive agent is imaged. A clinical evaluation report was submitted to evaluate the images obtained when this product was applied to the breast. |
| Jul 10, 2012 | Biolox Option HeadHemi hip prosthesis | B. Braun Aesculap Japan Co., Ltd. | New device | Apr 29, 2009 | 38 mo later | 1489 days | A stem head made of a zirconia-toughened high-purity aluminum matrix composite (BIOLOX® Delta) and used in combination with the company's approved system and "Ceramic Hip System Delta". The raw material of this system is innovative as an artificial hip prosthesis in Japan. The equivalence of the shape between the approved products and this product was explained, and a clinical evaluation report was submitted to provide clinical evaluation of differences in the raw materials. |
| Jul 10, 2012 | Ceramic Hip System DeltaTotal hip prosthesis | B. Braun Aesculap Japan Co., Ltd. | New device | Nov 20, 2008 | 44 mo later | 1404 days | This product consists of a stem head made of a zirconia-toughened high-purity aluminum matrix composite (BIOLOX® Delta) and a liner for shelf operation. It is used in combination with the company's approved system. Although the raw material of this system is innovative as an artificial hip prosthesis in Japan, a clinical evaluation report was submitted to explain the equivalence of the shape between the approved products and this product and the clinical evaluation of differences in the raw materials. |
| Jul 3, 2012 | Versajet SHydraulic knife | Smith & Nephew Wound Management K.K. | New device | Mar 31, 2000 | 147 mo later | 627 days | A device to be used for wound debridement (acute wound, chronic wound and thermal burn), soft tissue debridement and cleaning of surgical wound site. With the high-pressure water flow and its Venturi effect, it enables debridement and cleaning of surgical wound site. While it has the same mechanism of tissue ablation as the approved product, a major difference is that this product was developed as a device for debridement. A clinical study was conducted to evaluate the efficacy and safety of this product in wound debridement. |
| Jun 26, 2012 | RefitArtificial bone using collagen | Hoya Corporation | New device | Not listed | — | 358 days | An artificial bone implant made of sponge-like low- crystalline calcium phosphate and swine collagen. It is intended to enhance the porosity and improve the elasticity and bioabsorption. Since this product is a new raw material, a clinical study was conducted to confirm the effect of this product to promote bone regeneration for bone defects is equivalent to or greater than the existing products. |
| Jun 25, 2012 | Thermogard SystemCentral venous placement temperature management system | ZOLL Circulation, Inc. | New device | Aug 1, 2003 | 107 mo later | 1666 days | A temperature management device to regulate the body temperature by heat exchange with the blood within a blood vessel through a central venous catheter balloon in which a perfusion fluid (physiological saline) circulates in patients who need body temperature management. The product consists of a main device to deliver the perfusion fluid whose temperature is adjusted in the thermostatic chamber of the product and a central venous catheter with a perfusion-type balloon. Clinical studies were conducted to evaluate the performance and adverse events of this product when used in the human body. |
| Jun 25, 2012 | Expansor Balloon CatheterBalloon catheter for neuroendoscopy | Fuji Systems Corporation | New device | Not listed | — | 620 days | A balloon catheter which is inserted through a working channel of the endoscopy to expand a puncture hole created by an endoscopic clamp, etc. during surgery for hydrocephalus using neuroendoscopy (ventriculostomy, laparoscopic fenestration of cyst, etc.). Because there is no balloon catheter indicated for this treatment, a clinical evaluation report summarizing the results of literature searches on the efficacy and safety of this treatment using the balloon catheter was submitted. |
| May 31, 2012 | Nipro Polyether Sulfone DialyzerHollow-fiber dialyzer | Nipro Corporation | New device | Not listed | — | 330 days | A hollow-fiber dialyzer intended to remove fluid and uremic substances stored in the body due to uremia. It is indicated for patients whose renal function has markedly reduced due to chronic or acute renal failure, etc. Although this product uses the same membrane material as the approved products, because equivalence to the approved products was not demonstrated with regard to the performance profile, a clinical study was conducted to evaluate its performance profile. |
| May 25, 2012 | Monarc Transobturator SystemUrinary incontinence treatment tape | American Medical Systems, Inc. | New device | Nov 19, 2002 | 114 mo later | 1123 days | This product consists of a mesh to be placed suburethrally and its introducer, both of which are intended to improve stress urinary incontinence in women caused by urethral hypermobility or intrinsic sphincter deficiency of the urethra. While the approved product is placed retropubically, this product is placed in the obturator foramen. A clinical study was conducted to evaluate the objective efficacy (pad weight test, cough stress test, etc.), subjective efficacy (QOL improvement), and safety of this product for stress urinary incontinence. |
| May 18, 2012 | Spider Protection DeviceEmboli-capturing catheter in the central circulatory system | At the time of approval, ev3 K.K.; currently (post-approval transfer of approval), Covidien Japan Inc. | New device | Feb 16, 2006 | 75 mo later | 1569 days | A device to prevent distal emboli, which is used for capture and removal of obstructing materials such as thrombi during percutaneous carotid artery stenting. It is transdermally inserted into blood vessels and temporarily placed in the distal side of a lesion. Clinical studies were conducted to evaluate the efficacy and safety of this product in patients with angiostenosis in the carotid artery with the rate of stenosis of at least 70% (for asymptomatic patients) and at least 50% (for symptomatic patients). |
| May 18, 2012 | PROTEGE Carotid Stent SetStent for the carotid artery | At the time of approval, ev3 K.K.; currently [post-approval transfer of approval], Covidien Japan Inc. | New device | Jan 24, 2007 | 64 mo later | 1449 days | A stent which is used to expand the carotid artery (common carotid artery, internal carotid artery) or maintain the lumen in patients who are at high risk for adverse events by surgical treatment (carotid endarterectomy), and a delivery catheter that transdermally delivers the stent to the site of stenosis in the carotid artery. Clinical studies were conducted to evaluate the efficacy and safety of this product in patients with angiostenosis in the carotid artery with the rate of stenosis of at least 70% (for asymptomatic patients) and at least 50% (for symptomatic patients). |
| May 18, 2012 | Resolute Integrity Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Feb 17, 2012 | 3 mo later | 364 days | A drug-eluting stent coated with zotarolimus to inhibit the neointimal proliferation and a delivery catheter. The improvemjent from the approved "Endeavor Coronary Stent System" is the prolonged drug-eluting duration as a result of modification of the drug coating base material. A clinical study was conducted to evaluate the efficacy and safety of this product including such improvement in patients with symptomatic ischemic heart disease. |
| May 15, 2012 | Tecnis 1-Piece VBPosterior chamber lens | AMO Japan K.K. | New device | Not listed | — | 407 days | A monofocal posterior chamber lens to be implanted in the posterior chamber of the eye as a substitute for the crystalline lens to correct the vision of the aphakic eye. As the raw materials, an ultraviolet absorbing agent and a violet light absorbing agent, both of which are new covalent materials, were added to acrylic- methacrylic cross-linked copolymer, a base material of the approved "Tecnis 1-Piece". A clinical study was conducted to evaluate the optical efficacy and safety of the new raw materials. |
| Apr 24, 2012 | Thermocool SmarttouchCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Not listed | — | 407 days | An electrode catheter with the irrigation system used for radiofrequency catheter ablation and electrophysiological study. The contact force-sensing function is loaded at the tip of electrode; it is used to calculate and to display the degree of contact between the tip and the tissue. A clinical study was conducted to evaluate the behavior of contact force level in clinical use. |
| Apr 6, 2012 | XIENCE PRIME Drug-eluting Coronary Stent SystemCoronary stent | Abbott Vascular Japan Co., Ltd. | New device | Nov 1, 2011 | 5 mo later | 282 days | A drug-eluting stent coated with everolimus to inhibit the neointimal proliferation and a delivery catheter. The improvements from the company's predicate device are the different strut and the new stent lengths, 33 mm and 38 mm. Clinical studies were conducted to evaluate the efficacy and safety of this product in patients with symptomatic ischemic heart disease. (The original product is in a reexamination period) |
| Mar 29, 2012 | Medtronic Advisa MRIImplantable cardiac pacemaker | Medtronic Japan Co., Ltd. | New device | Not listed | — | 538 days | An implantable cardiac pacemaker used to treat bradycardia. The design concept allows MRI examination to patients implanted with the device; it is the first MRI-compatible pacemaker in Japan. The device has the identical pacing function with the approved product "Medtronic Advisa DR." It is used in combination with "CapSure FIX MRI leads" as implantable pacemaker leads. A clinical study using the previous product was conducted to confirm the safety of MRI examination to patients implanted with the device. |
| Mar 29, 2012 | CapSureFix MRI LeadEndocardial implantable pacemaker leads | Medtronic Japan Co., Ltd. | New device | Feb 8, 2011 | 14 mo later | 538 days | Implantable pacemaker leads used by connecting them to an implantable cardiac pacemaker. The design concept allows MRI examination to patients implanted with the device when used in combination with "Medtronic Advisa MRI." A clinical study was conducted to confirm the safety of MRI examinations to patients implanted with the device. |
| Mar 29, 2012 | VALIANT Thoracic Stent Graft SystemAortic stent graft | Medtronic Japan Co., Ltd. | New device | Apr 1, 2011 | 12 mo later | 359 days | This product consists of a stent graft and delivery system used for endovascular treatment of descending thoracic aortic aneurysm. Compared to the approved product "TALENT Thoracic Stent Graft System" (Approval No. 22100BZX00355000), improvements such as improvement of the stent graft design and introduction of a tip-capture system to the distal side of the delivery system (enhancement of the control capability for positioning the stent graft) were performed. A clinical study was conducted to evaluate the efficacy and safety of this product in the treatment of descending thoracic aortic aneurysm. |
| Mar 26, 2012 | Given Patency Capsule EndoscopeCapsule electronic endoscope system | Given Imaging K.K. | New device | May 8, 2006 | 71 mo later | 536 days | A product to take and provide images of the small- intestinal mucosa for diagnosis of small-intestinal diseases. The approved product "Given Capsule Endoscope (Approval No. 22100BZX00363000) has been improved with the addition of Agile J Patency Capsule (AJP), which is used to assess appropriateness of the patency of the digestive tract prior to the use of a capsule endoscope in patients who have or are suspected of having stenosis or narrowing of the digestive tract. A clinical evaluation report summarizing literature information, etc. on occurrence of retention of capsule endoscopes after assessment of patency by AJP was submitted to evaluate the accuracy of assessment of patency with AJP. |
| Mar 19, 2012 | Breath-O CorrectOrthokeratology contact lens | Universal View Co., Ltd. | New device | Not listed | — | 537 days | An orthokeratology contact lens with a special shape added to the inner lens surface that is intended to reshape the corneal surface by wearing it during sleep and to correct and maintain the unaided vision during daytime after removal of the lens. A clinical study was conducted to evaluate the efficacy of the correction precision, etc. and the safety for corneal disorder, etc. (The original product is in a reexamination period) |
| Mar 19, 2012 | Avansee 1PPosterior chamber lens | Kowa Company, Ltd. | New device | Not listed | — | 493 days | A monofocal posterior chamber lens to be implanted in the posterior chamber of the eye as a substitute for the crystalline lens to correct the vision of the aphakic eye. A one-piece lens for which the optic and haptic are made from the same material. As the raw material has novelty, a clinical study was conducted to evaluate the efficacy for vision correction and the safety for the eye. |
| Mar 8, 2012 | SJM Trifecta ValveBovine pericardial valve | St. Jude Medical Japan Co., Ltd. | New device | Apr 20, 2011 | 11 mo later | 416 days | A bovine pericardial valve to be used to substitute for the function of aortic valves with a disease, damage, or dysfunction. This product is to be implanted into the supra annular position. It is treated for anticalcification. Pig pericardial membrane is used at the outflow of the stent for the protection of the valve leaflet. A clinical study was conducted to confirm the clinical safety and efficacy of this product. |
| Feb 23, 2012 | Mechanical Microkeratome M2Mechanical keratome | Moria Japan K.K. | New device | Oct 12, 2000 | 136 mo later | 1704 days | A medical blade (mechanical keratome) for lamellar resection of the cornea in LASIK (laser in situ keratomileusis). A flap is made by putting negative pressure around the sclera to stabilize the cornea and resecting the corneal surface layer with the self- propelled blade. A clinical study was conducted to evaluate the efficacy in terms of the precision, quality, etc. of the flap, and the safety for the cornea, etc. |
| Feb 23, 2012 | Blazer Prime XP Ablation CatheterCardiovascular ablation catheter | Boston Scientific Japan K.K. | New device | Oct 2, 2009 | 29 mo later | 423 days | An electrode catheter to apply radiofrequency current to the target site of arrhythmia identified electrophysiologically, in order to treat persistent or recurrent type I atrial flutter. The shaft part was improved in order to enhance the delivery capability. A clinical study was conducted to evaluate the efficacy and safety to use the device for persistent or recurrent type I atrial flutter. |
| Feb 21, 2012 | ExoSealAbsorbable topical hemostatic material | Johnson & Johnson K.K. | New device | May 19, 2011 | 9 mo later | 424 days | An absorbable topical hemostatic material to be used for hemostasis at the femoral artery puncture site in patients who have undergone percutaneous catheterization. The product consists of a polyglycolic acid plug which is a bioabsorbable material and a delivery system to place the plug. This product is intended for hemostasis by placement of the plug on the side of the vascular wall tissue. A clinical study was conducted to confirm the efficacy and safety of this product for hemostasis at the femoral artery puncture site. |
| Feb 17, 2012 | Arthrex Bio-FASTak Suture AnchorAbsorbable screw for internal fixation | Kobayashi Medical Co., Ltd. | New device | May 1, 2000 | 142 mo later | 1803 days | An absorbable screw-type suture anchor made of poly DL-lactic acid to be used to fix soft tissues to bones in shoulder joints. A clinical study was conducted to evaluate the efficacy and safety for the treatment of shoulder joint instability in order to evaluate whether tissues such as ligaments in shoulder joints can be repaired. |
| Feb 13, 2012 | Intracardiac Defibrillation Multi-catheterCardiac catheter- type electrode | Japan Lifeline Co., Ltd. | New device | Not listed | — | 770 days | A cardiac catheter electrode used for cardiac electrophysiological examination. Moreover, the device is connected with "Intracardiac Defibrillator" and used for defibrillation when atrial fibrillation, atrial flutter, or atrial tachycardia occurs during percutaneous catheter ablation or cardiac electrophysiological examination. A clinical study was conducted to evaluate the efficacy and safety of the defibrillation using the device. |
| Feb 13, 2012 | Intracardiac DefibrillatorManual defibrillator | Japan Lifeline Co., Ltd. | New device | Not listed | — | 770 days | This is a generator for electric defibrillation connected with "Intracardiac Defibrillation Multi- catheter" when atrial fibrillation, atrial flutter, or atrial tachycardia occurs during percutaneous catheter ablation or cardiac electrophysiological examination. A clinical study was conducted to evaluate the efficacy and safety of the defibrillation using the device. |
| Feb 8, 2012 | Promus Element Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Nov 22, 2011 | 3 mo later | 330 days | A product consisting of a drug-eluting stent coated with everolimus used for dilating and holding a stenotic site of the coronary artery in ischemic heart disease. Platinum chromium alloy is used as a raw material for the stent, and the stent strut design was changed from the original product. A clinical study was conducted to confirm the efficacy and safety for the treatment of coronary stenotic sites when using this product. (The original product is in a reexamination period) |
| Feb 2, 2012 | Promote QuadraImplantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 349 days | An implantable biventricular pacing pulse generator with defibrillator function and accessories to improve cardiac failure symptoms with regular and weak electrical stimulation to bilateral ventricular myocardium. The device conducts cardiac resynchronization therapy that synchronizes the ventricular contraction. The design concept is similar to that of the approved product "Promote Accel RF (Approval No.: 22200BZX00962000)", but the connector is changed from IS-1 (2 poles) to IS4 (4 poles) and the left ventricular pacing polarity is added. A clinical study was conducted to evaluate the efficacy and safety associated with an increase in pacing polarity (e.g. stability of 4-pole lead) . |
| Feb 2, 2012 | Unify QuadraImplantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 349 days | An implantable biventricular pacing pulse generator with defibrillator function and accessories to improve cardiac failure symptoms with regular and weak electrical stimulation to bilateral ventricular myocardium. The device conducts cardiac resynchronization therapy that synchronizes the ventricular contraction. The design concept is similar to that of the approved product "Unify (Approval No. 22300BZX00210000)", but the connector is changed from IS-1 (2 poles) to IS4 (4 poles) and the left ventricular pacing polarity is added. A clinical study was conducted to evaluate the efficacy and safety associated with an increase in pacing polarity (e.g. stability of 4-pole lead). |
| Feb 2, 2012 | QuartetImplantable defibrillator/pacema ker lead | St. Jude Medical Japan Co., Ltd. | New device | Nov 29, 2011 | 2 mo later | 349 days | A left ventricular lead and accessories to improve cardiac failure symptoms with regular and weak electrical stimulation to bilateral ventricular myocardium. The device is connected with a biventricular pacing pulse generator with defibrillator function when performing cardiac resynchronization therapy. The device has 4 poles and allows to select the more options for pacing polarity than the approved left ventricular leads, which have 2 poles. A clinical study was conducted to evaluate the efficacy and safety associated with an increase in pacing polarity (e.g. stability of 4-pole lead). |
| Jan 24, 2012 | Zilver PTX Drug-Eluting Peripheral StentDrug-eluting stent for femoral artery | Cook Japan Inc. | New device | Not listed | — | 543 days | A stent system consisting of a self-expanding nitinol stent to be inserted and placed at the site of a lesion to maintain the inner cavity of a stenosis site of the femoropopliteal artery and a delivery system to deliver the stent to the site of the lesion. The outer surface of the stent tube is coated directly with paclitaxel to prevent restenosis of the treated site due to neointimal proliferation. A clinical study was conducted to evaluate the efficacy and safety of this product in the treatment of symptomatic vascular diseases in the above-knee femoropopliteal artery. |
| Jan 24, 2012 | Zilver Flex Vascular Stent for SFAStent for blood vessel | Cook Japan Inc. | New device | Not listed | — | 375 days | A stent system consisting of a self-expanding nitinol stent to be inserted and placed at the site of a lesion to maintain the inner cavity of a stenosis site of the femoropopliteal artery and a delivery system to deliver the stent to the site of the lesion. A clinical study was conducted to evaluate the efficacy and safety of this product for bail-out use at the time of failure in intervention therapy for the treatment of symptomatic vascular diseases in the above-knee femoropopliteal artery. |
| Jan 17, 2012 | Select Secure LeadEndocardial implantable pacemaker leads | Medtronic Japan Co., Ltd. | New device | Aug 3, 2005 | 77 mo later | 823 days | A screw-in bipolar transvenous lead. The diameter of device is made smaller than usual leads by modifications such as removal of the lumen for stylet insertion; it aims to combine with "Medtronic Deflectable Catheter" that can be bent at the distal part of the catheter and to be located in cardiac chamber. A clinical study was conducted to evaluate the efficacy and the safety to place the device with "Medtronic Deflectable Catheter" through the comparison with lead placement using the conventional stylet. |
| Jan 17, 2012 | Medtronic Deflectable CatheterCardiac catheter introducer kit | Medtronic Japan Co., Ltd. | New device | Oct 25, 2006 | 63 mo later | 823 days | A guiding catheter and accessories to be used to pass leads for implantable cardiac pacemakers through the atrium or ventricle. It is used together with "Select Secure Lead." A clinical study was conducted to evaluate the efficacy and the safety to place "Select Secure Lead" with the device through the comparison with lead placement using the conventional stylet. |
| Jan 13, 2012 | Cerasorb MAbsorbable dental bone reconstruction implant material | Hakuho Corporation | New device | Jul 22, 2005 | 78 mo later | 840 days | An absorbable dental bone reconstruction implant material made from beta tricalcium phosphate (β- TCP) with a phase purity of higher than 99% in compliance with ASTM F 1088 and a granular product to be used as a substitute for bone for alveolar bone defects as a dental bone substitute (excluding indications on the assumption of placement of an implant). A clinical evaluation report was submitted to evaluate the clinical efficacy and safety of the product as a dental bone substitute. |
| Dec 20, 2011 | Alcon Ex-PRESS Glaucoma Filtration DeviceIntraocular drain | Alcon Japan Ltd. | New device | Mar 13, 2003 | 105 mo later | 418 days | A stainless-steel glaucoma filtration device intended to create an aqueous humor outflow pathway between the anterior chamber and extraocular segment and to lower the intraocular pressure by puncture and placement from the limbus into the anterior chamber under the scleral flap. A clinical evaluation report summarizing the results of literature search on the foreign clinical studies for subconjunctival placement and the survey results of literature regarding the experience of this product was submitted to evaluate the safety and efficacy for intraocular pressure lowering. |
| Dec 20, 2011 | MatsudaitoNon-absorbable local hemostatic material for central circulation system | Sanyo Chemical Industries, Ltd. | New device | Not listed | — | 554 days | A non-absorbable local hemostatic material consisting of a viscous liquid made of polyether- based fluorine-containing urethane prepolymer filled in syringe and accessory sheets and spatula. It is used for auxiliary hemostasis at the site of artificial anastomosis associated with thoracic aorta replacement or branching artery arch replacement in which hemostasis cannot be achieved by usual surgical procedures including ligation. Clinical studies were conducted to evaluate the efficacy and safety of the hemostatic effect of this product at sites of vascular anastomosis in thoracic aorta replacement. |
| Dec 20, 2011 | Fetal ShuntShunt for fetal pleural effusion | Hakko Co., Ltd. | New device | Not listed | — | 390 days | A shunt tube to be placed in the fetal pleural cavity under ultrasonic guidance and a delivery system for the purpose of continuously draining fetal pleural effusion into the maternal amniotic cavity. A clinical evaluation report summarizing the results of literature research on the efficacy and safety of fetal thoraco-amniotic shunt and results of clinical research in Japan was submitted. [Orphan device] |
| Dec 12, 2011 | NaviStar ThermoCool SFCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Dec 21, 2011 | Same month | 605 days | An electrode catheter with the irrigation function used for radiofrequency catheter ablation and electrophysiological study. The device was developed based on the approved product "NaviStar ThermoCool (Approval No. 22000BZX01645000)", and the catheter tip electrode design and the irrigation flow rate were changed. Clinical studies were conducted to evaluate the efficacy and safety of the use for atrial fibrillation and ventricular tachycardia. |
| Dec 6, 2011 | Geistlich Bio-OssNonabsorbable material for bone regeneration | Geistlich Pharma AG | New device | Jan 15, 2004 | 95 mo later | 832 days | A nonabsorbable bone substitute that uses bovine bones originating from Australia as raw material and is prepared in the form of granules by heating and drying. It is used with a membrane for filling up bone defects when Guided Tissue Regeneration (GTR) is performed for vertical bone defects and defects in bones with class II root bifurcation lesions that are destroyed by periodontal disease. A clinical study was conducted to evaluate the efficacy and safety with the objective of bone improvement by conducting combination therapy of this product which is a bone substitute for bone regeneration and a dental collagen membrane for vertical bone defects and root bifurcation lesions caused by periodontitis. |
| Dec 1, 2011 | Lacto Screw Suture AnchorAbsorbable ligament anchor | Biomet Japan, Inc. | New device | Nov 20, 2001 | 120 mo later | 975 days | A resorbable screw-type suture anchor made of polylactic/polyglycolic acid copolymer used to attach ligaments or tendons to bones with a suture. The device is to be used in patients who require repair due to damage of soft tissues in regions adjacent to the shoulder joint such as the articular labrum, and soft tissues of the elbow and hand joints. A clinical evaluation report summarizing literatures on clinical data using this device and other screw-type anchor made from the same raw material, was submitted to evaluate the efficacy and safety. |
| Dec 1, 2011 | AllThread Screw L15Absorbable ligament anchor | Biomet Japan, Inc. | New device | Jul 19, 2006 | 64 mo later | 945 days | A resorbable screw-type suture anchor made of polylactic/polyglycolic acid copolymer used to attach ligaments or tendons to bones with a suture. The device is to be used in patients who require repair due to damage of soft tissues in regions adjacent to the shoulder joint, and soft tissues of the elbow and hand joints. A clinical evaluation report summarizing literatures on clinical data using other screw-type anchor made from the same raw material as this device, was submitted to evaluate the efficacy and safety. |
| Nov 14, 2011 | HOYA iSiiMultifocal posterior chamber lens | HOYA Corporation | New device | Not listed | — | 1102 days | A multifocal posterior chamber lens to be inserted into an aphakic eye after cataract surgery, with multifocal function consisting of three zones for distant, near, and distant visions in a concentric pattern on the optic surface. A clinical study was conducted to evaluate the efficacy and safety of the intraocular lens, focusing on the efficacy of the multifocal mechanism. |
| Nov 14, 2011 | AF-1 iSiiPosterior chamber lens with an injector | HOYA Corporation | New device | Not listed | — | 1095 days | A posterior chamber lens with an injector, for which "HOYA iSii" is preloaded in an injector. A clinical study was conducted to evaluate the efficacy and safety of the intraocular lens, focusing on the efficacy of the multifocal mechanism. |
| Nov 14, 2011 | Niti-S Gastroduodenal StentGastroduodenal stent | Century Medical, Inc. | New device | Not listed | — | 693 days | A gastroduodenal stent to be used to maintain patency at stenotic sites in patients with unresectable malignant gastroduodenal stenosis who are not expected to achieve improvement with surgical treatment or other treatment methods. A clinical evaluation report summarizing the results of literature research on clinical data on gastroduodenal stent placement was submitted to evaluate the efficacy and safety. |
| Oct 20, 2011 | Activa RCElectrical brain stimulation device for tremor | Medtronic Japan Co., Ltd. | New device | Mar 27, 2009 | 31 mo later | 360 days | An electrical stimulation device to reduce tremors associated with Parkinson's disease, essential tremor, etc. that do not sufficiently respond to drug therapy. The device stimulates the deep brain unilaterally or bilaterally. It is designed based on the intrinsic concept of the approved product "Itrel II (Approval No. 21100BZY00563000)" with changing to a dual-channel type, adding an electrical charge function, multi-program function, and constant current mode stimulation function, increasing the maximum pulse rate, etc. The clinical efficacy and safety of the multi-program function, the increased maximum pulse rate and constant current mode are evaluated with a clinical evaluation report. |
| Oct 20, 2011 | Activa SCElectrical brain stimulation device for tremor | Medtronic Japan Co., Ltd. | New device | Jan 26, 2011 | 9 mo later | 360 days | An electrical stimulation device to reduce tremors associated with Parkinson's disease, essential tremor, etc. that do not sufficiently respond to drug therapy. The device stimulates the deep brain unilaterally or bilaterally. It is designed based on the intrinsic concept of the approved product "Itrel II (Approval No. 21100BZY00563000)" with adding a multi-program function and constant current mode stimulation function, increasing the maximum pulse rate, etc. The clinical efficacy and safety of the multi- program function, the increased maximum pulse rate and constant current mode are evaluated with a clinical evaluation report. |
| Sep 16, 2011 | ENDURANT Stent Graft SystemAortic stent graft | Medtronic Japan Co., Ltd. | New device | Dec 16, 2010 | 9 mo later | 421 days | The product consists of a stent graft and a delivery system used for endovascular treatment of lower abdominal aortic aneurysm of the renal artery. Compared to the approved product "TALENT Abdominal Stent Graft System," a tip-capture system was introduced and also the low profile delivery system was adapted in order to enhance the control capability for positioning the stent graft. A clinical study was conducted to confirm the efficacy and safety of this product for the treatment of aortic aneurysm. |
| Sep 5, 2011 | Taxus Element Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Apr 22, 2011 | 4 mo later | 418 days | A product consisting of a drug-eluting stent coated with paclitaxel and a delivery catheter to inhibit neointimal proliferation. The stent strut design of this product is changed and platinum chromium is used as a raw material for the stent to enhance the deliverability. The use of semisynthetic paclitaxel was also added. A clinical study was conducted to confirm the efficacy and safety for the treatment of coronary stenotic sites by using this product. |
| Aug 31, 2011 | Baerveldt Glaucoma ImplantIntraocular drain | AMO Japan K.K.. | New device | Feb 11, 1991 | 247 mo later | 518 days | An artificial aqueous drainage device implanted to decrease intraocular pressure in patients with refractory glaucoma who have not responded to conventional therapy. It drains aqueous humor from the anterior or posterior chamber to the episclera to decrease intraocular pressure. Iｔ consists of a silicone plate and a tube and has holes for suturing the device to the sclera. It is available in straight tube type and pars plana insertion type. A clinical evaluation report summarizing the results of literature search on overseas clinical studies and experiences of this product was submitted to evaluate its safety and efficacy in decreasing intraocular pressure. [Priority review] |
| Aug 31, 2011 | CryoSeal Disposable kitInstrument & apparatus Blood component 7 separation kit | Asahi Kasei Kuraray Medical Co., Ltd. | New device | Jul 26, 2007 | 49 mo later | 257 days | A device to be used to prepare a biological tissue adhesive of autologous plasma origin in a sterilized closed circuit for patients whose blood was donated for preserved blood type autotransfusion. This product is to be used with "CryoSeal CS-1." Biological tissue adhesives prepared with this product are used in the adhesion and closure of tissues (in the case of leakage of blood, body fluid, or internal gas from sutured or bonded tissues). Clinical studies were conducted to evaluate efficacy and safety concerning the adhesion and closure of tissues by biological tissue adhesives prepared using this product. |
| Aug 31, 2011 | CryoSeal CS-1Apparatus for blood component separation | Asahi Kasei Kuraray Medical Co., Ltd. | New device | Jul 26, 2007 | 49 mo later | 257 days | A device to be used to prepare a biological tissue adhesive of autologous plasma origin in a sterilized closed circuit for patients whose blood was donated for preserved blood type autotransfusion. This product is to be used with "CryoSeal Disposable Kit." Biological tissue adhesives prepared with this product are used in the adhesion and closure of tissues (in the case of leakage of blood, body fluid, or internal gas from sutured or bonded tissues). Clinical studies were conducted to evaluate efficacy and safety concerning the adhesion and closure of tissues by biological tissue adhesives prepared using this product. |
| Aug 26, 2011 | AvairaReusable colored contact lenses for correcting visual acuity | CooperVision Japan, Inc. | New device | Jan 4, 2008 | 44 mo later | 227 days | Reusable colored contact lenses for correcting visual acuity. The silicone hydrogel lens is indicated for daily wear and replaced in two-week intervals. There is no novelty in the lens design, but the use of cross- linking agent and ultraviolet absorbing agent and the blend ratio of monomer among raw materials have novelty, and therefore a clinical study was conducted to confirm the efficacy and safety for wearing the lens for vision correction. |
| Aug 2, 2011 | Integrity Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Sep 14, 2010 | 11 mo later | 368 days | A stent set for percutaneous coronary stent placement to be inserted and placed at the site of a lesion to maintain the vascular lumen. The approved product is formed by lining up the rings with crowns, whereas this product is formed by wrapping a wire that has crowns. A clinical evaluation report was submitted to confirm that this product can be used similarly to the approved product. |
| Jul 21, 2011 | VertaPlex Bone CementOrthopedic bone cement | Stryker Japan K.K. | New device | Dec 7, 2007 | 43 mo later | 659 days | An orthopedic bone cement to mitigate pain that is used in percutaneous vertebroplasty in patients with malignant spinal tumor such as painful metastatic bone tumor and myeloma who have not responded to conventional therapy. This product was developed with the aim of attaining a working time longer than that of the original product "Stryker Bone Cement for Exclusive Use in the Spine" (22100BZX01112000) by containing a homopolymer component without the styrene group and decreasing a catalyst. A clinical evaluation report summarizing a literature search on the results of domestic general clinical studies including previous products and the clinical results of bone cement that is used in percutaneous vertebroplasty in Japan and overseas was submitted to evaluate its efficacy and safety. |
| Jul 7, 2011 | Kaneka PTCA Catheter CO-R5Balloon-dilating coronary perfusion catheter for angioplasty | Kaneka Corporation | New device | Not listed | — | 251 days | A balloon catheter to be used for dilating stenotic sites in percutaneous transluminal coronary angioplasty (PTCA) or temporary sealing of blood vessel perforations caused during PTCA. With multiple holes made on the proximal and distal sides of the balloon, it enables perfusion from the proximal to distal side during expansion of the balloon. A clinical evaluation report was submitted to confirm the efficacy and safety of the use of the catheter for sealing of blood vessel perforations. |
| Jul 7, 2011 | WallFlex Colonic StentColonic stent | Boston Scientific Japan K.K. | New device | Sep 30, 2004 | 81 mo later | 645 days | A colonic stent to be used for colonic strictures produced by malignant neoplasm to relieve large bowel obstruction prior to operation, also to be used for the palliative treatment for patients who cannot be managed by palliative surgical treatment or are not expected to achieve improvement with other treatments. A clinical evaluation report was submitted to evaluate the efficacy and safety for the use of this product for preoperative relief of bowel obstruction or as palliative treatment. |
| Jul 5, 2011 | SJM FD-OCT Imaging SystemOCT diagnostic imaging instrument | St. Jude Medical Japan Co., Ltd. | New device | May 3, 2010 | 14 mo later | 333 days | The OCT diagnostic imaging instrument is intended for intravascular tomographic imaging. The device is for exclusive use with the catheter "SJM OCT Imaging Catheter". A clinical study was conducted to evaluate the observation capability and the intrinsic safety for target patients. |
| Jul 5, 2011 | SJM OCT Imaging CatheterIntravascular optical tomographic catheter | St. Jude Medical Japan Co., Ltd. | New device | May 3, 2010 | 14 mo later | 333 days | The catheter is intended for intravascular tomographic imaging. The device is for exclusive use with "SJM FD-OCT Imaging System." A clinical study was conducted to evaluate the observation capability and the intrinsic safety for target patients. |
| Jun 14, 2011 | OsmixArtificial bone implant | Kuraray Medical Inc. | New device | Not listed | — | 1174 days | An artificial bone implant in paste form for which silane-coating hydroxyapatite particles and polymerizable monomers are mixed. This product is designed to start polymerization when discharged from the dedicated injector. It is injected into the affected site in paste form to compensate for bone defects after reconstruction of bone fracture of non- loaded region and for bone defects after removals of bone tumor/necrosis bone. A clinical study was conducted to confirm the efficacy and safety of the use of the novel raw material. |
| Jun 14, 2011 | TwinFix AB AnchorAbsorbable ligament anchor | Smith & Nephew Endoscopy KK | New device | Jun 27, 2001 | 120 mo later | 287 days | An absorbable suture anchor to be used to repair the binding of soft tissues such as ruptured tendons, ligament, and muscles to bones. The product is only indicated for repair of rotator cuff tear in the shoulder. The improvement from the approved nonabsorbable product is the use of absorbable poly-L-lactic acid as raw material for the anchor. A clinical study was conducted to evaluate the efficacy and safety of this product which is an absorbable screw-type anchor. |
| Jun 9, 2011 | Penumbra SystemEmboli-removal catheter in the central circulatory system | Medico's Hirata Inc. | New device | Dec 28, 2007 | 41 mo later | 479 days | A device used for thrombectomy. Patients in acute phase of cerebral infarction who are ineligible for intravenous infusion of tissue plasminogen activator (t-PA) or who fail intravenous infusion of t-PA to restore blood flow are candidates for treatment. It is a product to aspirate the thrombus by connecting a reperfusion catheter and an aspiration pump (Penumbra aspiration pump) via an aspiration tubing. A clinical study was conducted to evaluate its efficacy and safety in thrombectomy for cerebral infarction. |
| Apr 28, 2011 | Aquala LinerArtificial hip joint, acetabular component | Japan Medical Materials Corporation | New device | Not listed | — | 388 days | An ultra-high-molecular-weight polyethylene liner for an artificial hip joint. This product is photoinduced graft-polymerized with 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer on the bearing surface in addition to cross-link processing, in order to improve the wear resistance of the bearing surface while inheriting the design of the approved products. A clinical study was conducted to confirm the efficacy and safety of the liner for which the bearing surface was modified with the novel raw material. |
| Apr 18, 2011 | AMS GreenLight HPS ConsoleDouble-frequency neodymium-YAG laser | American Medical Systems, Inc. | New device | Dec 1, 2006 | 53 mo later | 755 days | A surgical device for resection of the prostate gland with 532 nm double-frequency neodymium-YAG laser under cystoscopy for the treatment of benign prostate hypertrophy/hyperplasia. Improvements from the approved product are the use of the oscillation wavelength of 532 nm and change of the maximum output power to 120 W. A clinical study was conducted to confirm the efficacy and safety of this product for benign prostate hypertrophy/hyperplasia. |
| Apr 18, 2011 | AMS GreenLight HPS FiberSingle-use probe for laser guidance | American Medical Systems, Inc. | New device | Dec 1, 2006 | 53 mo later | 755 days | A side-firing fiber to be used in combination with the surgical device "AMS GreenLight HPS Console" to resect the prostate gland with 532 nm double- frequency neodymium-YAG laser under cystoscopy for the treatment of benign prostate hypertrophy/hyperplasia. A clinical study was conducted to confirm the efficacy and safety of this product for benign prostate hypertrophy/hyperplasia. |
| Apr 13, 2011 | Fortify ST PreAutomatic implantable defibrillator | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 285 days | An implantable defibrillator with the function of bradycardia pacing. The four variations of conectors are as follows: single-chamber types (VR) (IS-1/DF-1 or DF4 connector) and dual-chamber types (DR) (IS- 1/DF-1 or IS-1/DF4 connector). Improvements compared with approved defibrillators are as follows: (1) downsizing, (2) addition of thoracic impedance measurement function, (3) addition of ATP treatment in the VF zone, (4) addition of pacing rate alert, (5) addition of low-frequency attenuation filter and (6) setting of the maximum defibrillation energy to be 40J. The device automatically adjusts pulse amplitude, when the patient's ventricular and atrial thresholds change. The efficacy and safety of the function was evaluated by the results of clinical studies for the different defibrillator, because another device with the identical function was under review at the time to compile this application. |
| Apr 13, 2011 | UnifyImplantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 285 days | An implantable biventricular pacing pulse generator with defibrillator function. The two variations of connector are as follows: IS-1/DF4 connectors. Improvements from approved defibrillators are as follows: (1) downsizing, (2) addition of thoracic impedance measurement function, (3) addition of ATP treatment in the VF zone, (4) addition of pacing rate alert, (5) addition of low-frequency attenuation filter, and (6) setting of the maximum defibrillation energy to be 40J. The device automatically adjusts pulse amplitude, when the patient's ventricular and atrial thresholds change. The efficacy and safety of the function was evaluated by the results of clinical studies for the different defibrillator, because another device with the identical function was under review at the time to compile this application. |
| Apr 8, 2011 | SJM Epic Stented Tissue ValvePorcine cardiac valve | St. Jude Medical Japan Co., Ltd. | New device | Nov 15, 2007 | 41 mo later | 952 days | A biological prosthetic cardiac valve with stent derived from pig aortic valve that is intended to substitute for the function of aortic valves or mitral valves with a disease, damage, or dysfunction. This product is treated for anticalcification and uses bovine pericardial membrane at the stent part for the protection of the valve leaflet. A clinical study was conducted to confirm the efficacy and safety of this product. |
| Mar 29, 2011 | Situs 2 OTW LeadImplantable defibrillator/ pacemaker lead | Sorin CRM | New device | Not listed | — | 456 days | A bipolar left ventricular pacing lead for coronary veins and its accessory connected to CRT-P and CRT-D and used during cardiac resynchronization treatment. The first left ventricular pacing lead of the company. Results from clinical studies were submitted to evaluate its efficacy and safety. |
| Mar 16, 2011 | COOK Zenith TX2 TAA Endovascular GraftAortic stent graft | Cook Japan Inc. | New device | May 21, 2008 | 34 mo later | 866 days | This product consists of a stent graft and delivery system used for endovascular treatment of descending thoracic aortic aneurysm. It consists of a self-expanding stainless-steel stent and polyester graft. A clinical study was conducted to evaluate the efficacy and safety of stent graft treatment for thoracic aortic aneurysm. |
| Mar 9, 2011 | Cochlear Baha SystemBone-anchored hearing aid | Cochlear Ltd. | New device | Aug 9, 1996 | 175 mo later | 538 days | A bone-anchored hearing aid that transmits sound vibrations to the bone to improve the ability to hear environmental sounds and speech sounds. A clinical study was conducted to evaluate the efficacy and safety of this product in patients who are not expected to achieve improvement with existing treatments. |
| Mar 9, 2011 | NoboriCoronary stent | Terumo Corporation | New device | Not listed | — | 439 days | A stent system for percutaneous coronary stent placement consisting of a stent to be inserted and placed at the site of a lesion to maintain the vascular lumen and a delivery catheter used to deliver the stent to the site of the lesion. The stent is coated with biolimus A9 with cytostatic effect to topically inhibit neointimal proliferation that is thought to be a cause of in-stent restenosis. Clinical studies were conducted to evaluate the efficacy and safety of this product with high-novelty coating. |
| Feb 23, 2011 | COOK Vascular StentStent for iliac artery | Cook Japan Inc. | New device | Jun 26, 2006 | 56 mo later | 1052 days | This product consists of a stent and delivery system used for treatment of symptomatic vascular diseases such as a stenotic lesion with a reference vessel diameter of 5-9 mm in the iliac artery. A clinical study was conducted to evaluate the efficacy and safety of this product in maintaining vascular patency when it was placed at a stenotic lesion in the iliac artery. |
| Feb 23, 2011 | Visceral Fat Area Measurement Device HDS-2000Body constituent analysis instrument | Omron Healthcare Co., Ltd. | New device | Not listed | — | 208 days | A body constituent analysis instrument that estimates and shows a cross-sectional area of visceral fat based on bioelectrical impedance level and major axis and minor axis of cross-sectional area of the abdomen. It is indicated for secondary screening (detection of cross-sectional area of visceral fat ≦ 2 100 cm ) of patients who are tested positive according to the diagnostic criteria using abdominal circumference, one of the diagnostic criteria for metabolic syndrome. A clinical study was conducted to evaluate the estimation precision of the cross- sectional area of visceral fat in relation to correlation with the cross-sectional area of visceral fat obtained from CT images. |
| Feb 2, 2011 | Fall in Eyez-2 Reusable colored contact lenses not for correcting visual acuity | Destiny International Co., Ltd. | New device | Not listed | — | 92 days | A reusable colored contact lens that is not for correcting visual acuity that is indicated for daily wear and replaced monthly. Since equivalence to the approved product was not demonstrated with regard to the compounding ratio of the raw material monomer and cross-linker, a clinical study was conducted to evaluate its efficacy and safety. |
| Feb 2, 2011 | FibroscanVersatile ultrasound diagnostic imaging device | InterMedical Co., Ltd. | New device | Not listed | — | 687 days | A device to measure non-invasively liver stiffness using ultrasonic waves, etc. A clinical study was conducted to evaluate whether it could qualitatively measure the stiffness of the liver. |
| Jan 6, 2011 | BiohesiveAntibacterial wound dressing and protecting material | Alcare Co., Ltd. | New device | Not listed | — | 1011 days | A wound dressing and protecting material used to protect wound reaching subcutaneous adipose tissue, maintain a moist environment, promote healing and relieve pain. With hydrocolloid material as a base material, this product contains sulfadiazine silver 0.05% to improve hygiene inside the dressing material. Since equivalence to the approved product was not demonstrated with regard to this structure, a clinical study was conducted to evaluate its efficacy and safety. |
| Dec 17, 2010 | TALENT Abdominal Stent Graft SystemAortic stent graft | Medtronic Japan Co., Ltd. | New device | Apr 15, 2008 | 32 mo later | 521 days | A stent graft for abdominal aortic aneurysm used to prevent blood flow into abdominal aortic aneurysm and prevent rupture of aortic aneurysm. A clinical study was conducted to evaluate the efficacy and safety of stent graft treatment for abdominal aortic aneurysm. |
| Dec 17, 2010 | AnalyST Accel RF VRAutomatic implantable defibrillator | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 366 days | Automatic implantable defibrillator with the function of single-chamber bradycardia pacing. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular threshold were submitted to evaluate the efficacy and safety of this function. |
| Dec 17, 2010 | AnalyST Accel RF DRDual-chamber automatic implantable defibrillator | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 365 days | Automatic implantable defibrillator with the function of dual-chamber bradycardia pacing. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 17, 2010 | Promote Accel RFImplantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Jan 29, 2010 | 11 mo later | 365 days | An implantable pulse generator that delivers CRT. A clinical study was conducted to evaluate the efficacy and safety of a function to automatically adjust pulse amplitude according to a change in the patient's biventricular and atrial thresholds. |
| Dec 14, 2010 | Express SD Renal Artery Dilatation Stent SystemStent for blood vessel | Boston Scientific Japan K.K. | New device | Dec 11, 2008 | 24 mo later | 595 days | A balloon dilating stent system developed for maintaining vascular patency of an atherosclerotic lesion occurring at the opening of the renal artery. A clinical study was conducted to evaluate the efficacy and safety of this product in maintaining vascular dilatation when it was placed at an atherosclerotic lesion occurring at the entrance of the renal artery. |
| Dec 14, 2010 | Ovatio CRT-DInstrument & apparatus Implantable 7 biventricular pacing pulse generator with defibrillator function | Sorin CRM | New device | May 15, 2008 | 31 mo later | 897 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. A clinical study was conducted to evaluate the efficacy and safety of this product as a CRT-D system. |
| Dec 14, 2010 | Paradym CRT-DImplantable biventricular pacing pulse generator with defibrillator function | Sorin CRM | New device | Oct 27, 2009 | 14 mo later | 482 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. A clinical study was conducted to evaluate the efficacy and safety of this product as a CRT-D system. |
| Dec 9, 2010 | Nuance DR RFImplantable cardiac pacemaker | Fukuda Denshi Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 324 days | Dual-chamber implantable cardiac pacemaker. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 9, 2010 | Nuance DRImplantable cardiac pacemaker | Fukuda Denshi Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 324 days | Dual-chamber implantable cardiac pacemaker. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 8, 2010 | DuraHeart Left Ventricular Assist SystemInstrument &apparatus 7 Implantable ventricular assist device | Terumo Corporation | New device | Not listed | — | 447 days | An implantable left ventricular assist device intended for use to improve the blood circulation in patients with end-stage heart failure who require cardiac transplantation. In addition to clinical studies conducted in Europe, where it was used earlier than in Japan, clinical studies were also conducted to investigate the efficacy and safety of this product to the target patients and to confirm the conformity to the medical environment in Japan. [Orphan device] |
| Dec 8, 2010 | Implantable Ventricular Assist System EVAHEARTInstrument &apparatus 7 Implantable ventricular assist device | Sun Medical Technology Research Corp. | New device | Not listed | — | 688 days | An implantable left ventricular assist device intended for use to improve the blood circulation in patients with end-stage heart failure who require cardiac transplantation. Clinical studies were conducted to investigate the efficacy and safety of this product to the target patients and to confirm the conformity to the medical environment in Japan. [Orphan device] |
| Dec 7, 2010 | Accent DR ACCImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 326 days | Dual-chamber implantable cardiac pacemaker. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 7, 2010 | Accent RF DR ACCImplantable cardiac pacemaker | St. Jude Medical Japan Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 326 days | Dual-chamber implantable cardiac pacemaker. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in patient's ventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 7, 2010 | Anthem ACCImplantable biventricular pacing pulse generator without defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 326 days | An implantable pulse generator that delivers CRT. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in the patient's biventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 7, 2010 | Anthem RF ACCImplantable biventricular pacing pulse generator without defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Jan 29, 2010 | 10 mo later | 326 days | An implantable pulse generator that delivers CRT. Results from clinical studies of a different model with a function to automatically adjust pulse amplitude according to a change in the patient's biventricular and atrial thresholds were submitted to evaluate the efficacy and safety of this function. |
| Dec 1, 2010 | MaxifluxHemodiafilter | Nipro Corporation | New device | Not listed | — | 404 days | A hollow fiber membrane hemodiafilter. Because equivalence to the approved products was not demonstrated with regard to the semipermeable membrane material and performance profile, a clinical study was conducted to evaluate its efficacy and safety. |
| Nov 9, 2010 | Trabecular Metal MonoblockArtificial knee joint, patellar and tibial component | Zimmer K.K. | New device | Jul 19, 2001 | 112 mo later | 855 days | A tibia component to be implanted at the tibial side to reconstruct the function of the knee joint and a patellar component to be implanted in the patella during knee replacement arthroplasty (including revision knee replacement arthroplasty). While the shape and size of this product are equal to those of the approved product, a metal part and ultrahigh molecular weight polyethylene part are compressed to form an integrated architecture. In addition, improved bone fixation and reduced stress shielding on bone are expected because of a new raw material (consecutive 3-D dodecahedron porous structure made from tantalum) used in this product. A clinical study was conducted to evaluate the efficacy and safety of this device with improved structure, etc. |
| Oct 8, 2010 | Attain Ability Straight LeadsImplantable defibrillator/ pacemaker lead | Medtronic Japan Co., Ltd. | New device | Not listed | — | 259 days | A tined lead to be placed in a coronary vein for CRT. A clinical study was conducted to demonstrate that the safety and efficacy of this product were within an acceptable range compared to the existing products. |
| Sep 29, 2010 | Bioglue Surgical AdhesiveSurgical adhesive | Century Medical, Inc. | New device | Apr 23, 1998 | 149 mo later | 2009 days | A surgical adhesive containing bovine serum albumin and glutaraldehyde as major ingredients. This product is used for adhesion and hemostasis at an artificial blood vessel suture site associated with closure of aortic dissection and aortic dissection lumen (including dissecting aneurysm of the aorta). A clinical study was conducted to evaluate the degree of adhesion (efficacy) and safety of this product in such surgeries. |
| Sep 14, 2010 | PTEG Kit (Akita Sumitomo Bakelite Co., Ltd.) Toraylight NVEnteral feeding kit for long-term use Instrument & apparatus 7 Hollow-fiber dialyzer | Toray Industries, Inc. | New device | Not listed | — | 487 days | An enteral feeding tube and its insertion kit used in a procedure for percutaneous trans-esophageal insertion and placement of a catheter in the gastrointestinal tract to provide enteral feeding and decompression to patients for whom it is difficult to perform gastrostomy. A clinical study was conducted to evaluate the efficacy and safety of percutaneous trans-esophageal gastro-tubing (PTEG) in patients receiving enteral feeding or decompression. A hollow fiber dialyzer. Because equivalence to the approved products was not demonstrated with regard to the semipermeable membrane material, a clinical study was conducted to evaluate its efficacy and safety. |
| Sep 14, 2010 | Trabecular Metal Modular Acetabular SystemArtificial hip joint, acetabular component | Zimmer K.K. | New device | Sep 5, 2002 | 96 mo later | 837 days | A locking ring used to fix a titanium alloy acetabular cup and liner that are used at the pelvic side to replace the function of the hip joint during hip replacement arthroplasty (including revision hip replacement arthroplasty). The outer surface is coated with a consecutive 3-D dodecahedron porous structure made from tantalum to ensure direct fixation to the bone. A clinical study was conducted to evaluate the efficacy and safety of this device with this novel surface structure. |
| Sep 3, 2010 | Revolution 2Central circulation system intravascular ultrasound catheter | Volcano Japan Co., Ltd. | New device | Jun 20, 2005 | 62 mo later | 1326 days | A catheter for intravascular ultrasound diagnostic imaging with a built-in ultrasound transducer for imaging intravascular lumen and vascular wall using ultrasound. The ultrasonic frequency of this product is 45 MHz. A clinical study was conducted to primarily evaluate system-related adverse events. |
| Sep 1, 2010 | My EmeraldOrthokeratology contact lens | Technopia Co., Ltd. | New device | Jun 7, 2004 | 75 mo later | 908 days | An orthokeratology contact lens for patients with myopia and myopic astigmatism to reshape the corneal anterior surface by wearing it during sleep and correct the unaided vision after removal of the lens. A clinical study was conducted to confirm the efficacy and safety of this product. (The original product is in a reexamination period) |
| Sep 1, 2010 | Visual EmeraldOrthokeratology contact lens | Technopia Co., Ltd. | New device | Jun 7, 2004 | 75 mo later | 908 days | An orthokeratology contact lens for patients with myopia and myopic astigmatism to reshape the corneal anterior surface by wearing it during sleep and correct the unaided vision after removal of the lens. Application for multiple brand name of "My Emerald". (The original product is in a reexamination period) |
| Aug 31, 2010 | Tion In OfficeDental 2 Dental bleaching material | GC Corporation | New device | Not listed | — | 1516 days | A dental bleaching agent exclusively designated for office bleaching containing hydrogen peroxide solution and urea hydrogen peroxide as major ingredients. This product was improved to achieve efficient bleaching using a reactor containing visible light-titanium oxide. A clinical study was conducted to evaluate the bleaching performance and safety of this product in discolored human teeth. |
| Aug 23, 2010 | Bausch&Lomb Ortho-kOrthokeratology contact lens | B.L.J. Company, Ltd. | New device | Aug 2, 2004 | 73 mo later | 1055 days | An orthokeratology contact lens for patients with myopia and myopic astigmatism to reshape the corneal anterior surface by wearing it during sleep and correct the unaided vision after removal of the lens. A clinical study was conducted to confirm the efficacy and safety of this product. (The original product is in a reexamination period) |
| Aug 23, 2010 | Precision Plus SCS SystemImplantable stimulator for pain relief | Boston Scientific Japan K.K. | New device | Oct 1, 2004 | 71 mo later | 482 days | An implantable stimulator for pain relief to be applied to patients with chronic refractory pain in the trunk and extremities who are not sufficiently responsive to pain relief therapy with drugs or nerve block. It can be charged non-invasively from outside the body. A clinical study was conducted to evaluate the safety and efficacy of this product for relief of chronic pain. |
| Jul 21, 2010 | Aime AquafinityReusable colored contact lenses for correcting visual acuity | Asahi Kasei Aime Co., Ltd. | New device | Dec 6, 2005 | 55 mo later | 411 days | A soft contact lens using silicone hydrogel for correcting visual acuity in myopia, hyperopia and astigmatism. The lens is made from a novel material that aims to improve the comfort in wearing while maintaining high oxygen permeability. |
| Jul 6, 2010 | GuardWire Protection SystemEmboli-removal catheter in the central circulatory system | Medtronic Japan Co., Ltd. | New device | Oct 31, 2007 | 32 mo later | 617 days | A balloon-type device to prevent distal emboli by capturing and removing embolic substances including thrombi released while a stent is placed in the carotid artery. The efficacy (the effect of preventing distal emboli) and safety of this product were evaluated based on a clinical study for a carotid artery stent used in combination with this product. (The original product is in a reexamination period) |
| Jul 5, 2010 | ZOLL AED Plus Automated External DefibrillatorAutomatic defibrillator for non- healthcare professionals | Zoll Medical Corporation | New device | May 21, 2004 | 73 mo later | 1036 days | A semi-automatic external defibrillator using biphasic defibrillation waveform dedicated for use by non- healthcare professionals, equipped with a pad with an acceleration sensor to enable the display of the rate and depth of chest compression during cardiopulmonary resuscitation. A clinical study was conducted to confirm the efficacy and safety of defibrillator function using biphasic waveform. |
| Jun 23, 2010 | Acuity SpiralImplantable defibrillator/ pacemaker lead | Boston Scientific Japan K.K. | New device | May 16, 2008 | 25 mo later | 545 days | A spirally-molded lead to be placed in the coronary vein for CRT. A clinical study was conducted to demonstrate that the safety and efficacy of this product were within an acceptable range compared to the existing products. |
| Jun 14, 2010 | Bard Agento I.C.Antimicrobial endotracheal tube | Medicon,Inc. | New device | Nov 6, 2007 | 31 mo later | 620 days | An endotracheal tube inserted into the trachea for airway management. The device has a hydrophilic silver coating with antimicrobial activity to reduce the incidence and delay the onset of ventilator- associated pneumonia (VAP). A clinical study was conducted to verify its effects on reducing the incidence and delaying the onset of VAP. |
| Jun 14, 2010 | ELVeS LaserDiode laser | Integral Corporation | New device | Aug 13, 2002 | 94 mo later | 766 days | A system intended for endovenous laser treatment of varicose veins of lower extremities. Endovenous laser irradiation obstructs a target vessel and blocks blood flow in the saphenous vein that causes varicose veins of lower extremities. A clinical study was conducted to confirm its efficacy and safety using stripping, a standard treatment, as a control. |
| Jun 14, 2010 | X-STOP PEEK ImplantSingle-use interspinous implant device | Medtronic Sofamor Danek Co., Ltd. | New device | Aug 8, 2006 | 46 mo later | 500 days | An implant to be implanted between target spinous processes in order to hold the lumbar spine in flexion and prevent it from going into extension for relief of lower back pain and leg pain in patients with lumbar spinal stenosis. A clinical study was conducted to verify its efficacy and safety with regard to the mechanism to physically broaden the gap between the upper and lower spinous processes. |
| Jun 14, 2010 | Tegaderm CHG DressingAntibacterial catheter dressing and protecting material | 3M Health Care Limited | New device | Apr 5, 2007 | 38 mo later | 377 days | A catheter dressing and protecting material that covers and protects an insertion site of a vascular catheter. A gel pad included in this device contains an antibacterial agent chlorhexidine gluconate that inhibits regrowth of skin bacterial flora at the insertion site. A clinical study was conducted to evaluate whether use of this product inhibited regrowth of skin bacterial flora on normal skin and the performance of fixation of a catheter with this product in patients inserted with a catheter. |
| Jun 2, 2010 | Intralase FS LaserOphthalmic laser corneal surgical instrument | AMO Japan K.K. | New device | Aug 16, 2006 | 46 mo later | 789 days | A Nd:Glass laser (wave length 1053 nm) surgical instrument used for creation of a corneal flap in LASIK (laser in-situ keratomileusis) and for cut/resection in keratoplasty. Creation of a corneal flap, lamellar and penetrating cut/incision can be performed with this product, instead of using a keratome or scalpel, in LASIK and keratoplasty. A clinical evaluation report summarizing the results of post-marketing clinical studies conducted by the manufacturer in the USA and literature searches were submitted to evaluate its efficacy and safety. |
| Jun 2, 2010 | Oral Moisture Checking Device MucusBody constituent analysis instrument | Life Co., Ltd. | New device | Not listed | — | 1098 days | A device used as a diagnostic aid that quantifies dryness of oral mucosa by converting an impedance level at the dorsum of the tongue measured by bioelectrical impedance analysis (BIA) technique to an amount of water. Quantification using this product is different from conventional gum test and Saxon test in that the measurement time is as short as approximately 2 seconds and measurement is possible regardless of the presence or absence of patient's consciousness. A clinical evaluation report summarizing the results of literature searches was submitted with regard to the appropriateness of a cut-off level for the degree of dryness and a correlation with the existing methods. |
| Apr 30, 2010 | Merci RetrieverEmboli-removal catheter in the central circulatory system | Century Medical,Inc. | New device | Aug 11, 2004 | 69 mo later | 458 days | A wire device with helical loops at the distal end used for thrombectomy. Patients in acute phase of cerebral infarction who are ineligible for intravenous infusion of tissue plasminogen activator (t-PA) or who fail intravenous infusion of t-PA to restore blood flow are candidates for treatment. A clinical study was conducted to evaluate its efficacy and safety in thrombectomy for cerebral infarction. [Priority review] |
| Apr 30, 2010 | The Crosser SystemOscillating peripheral artery recanalization catheter system | USCI Japan, Ltd. | New device | Dec 7, 2007 | 29 mo later | 497 days | A medical device used to facilitate guidewire recanalization with mechanical vibration for a stenotic lesion in the peripheral vessel that a conventional guidewire for angioplasty cannot cross in percutaneous transluminal angioplasty. A clinical study was conducted to confirm its efficacy and safety in the treatment of a stenotic lesion that a conventional guidewire for angioplasty cannot cross. |
| Mar 26, 2010 | ZOLL AED Pro Semi- Automatic DefibrillatorSemi-automatic defibrillator | ZOLL Medical Corporation | New device | Feb 4, 2005 | 62 mo later | 847 days | A semi-automatic external defibrillator using biphasic defibrillator waveform dedicated for use by healthcare professionals, equipped with a pad with an acceleration sensor to enable the display of the rate and depth of chest compression during cardiopulmonary resuscitation. A clinical study was conducted to confirm the efficacy and safety of defibrillator function using biphasic waveform. |
| Mar 4, 2010 | 1-Day Acuvue TruEyeSingle-use colored contact lenses for correcting visual acuity | Johnson & Johnson K.K. | New device | Mar 3, 2008 | 24 mo later | 769 days | A daily disposable soft contact lens for myopia, hyperopia, astigmatism, or presbyopia. A copolymer of HEMA, OH-mPDMS, and DMA is used as lens materials. Clinical studies were conducted to evaluate the efficacy and safety. |
| Feb 15, 2010 | Carotid Wallstent MonorailStent for the carotid artery | Boston Scientific Japan K.K. | New device | Oct 23, 2008 | 16 mo later | 374 days | A stent made of cobalt‐chromium alloy used for dilating and holding a stenotic site of the cartoid artery in cartoid stenosis. (The original product is in a reexamination period) |
| Feb 15, 2010 | FilterWire EZEmboli-capturing catheter in the central circulatory system | Boston Scientific Japan K.K. | New device | Dec 14, 2006 | 38 mo later | 374 days | A device to prevent distal emboli with a polyurethane filter to capture and remove embolic substances including thrombi released while a stent is placed in the carotid artery. (The original product is in a reexamination period) |
| Feb 5, 2010 | KYPHON BKP SystemSingle-use vertebral body restoration device | Medtronic Sofamor Danek Co., Ltd. | New device | Jul 2, 1998 | 139 mo later | 651 days | A treatment system to be used in percutaneous kyphosis correction performed for restoration of the height of fractured vertebral body, fixation of the vertebral body, and pain relief in spinal compression fracture. The novelty of this product is the capability to fill the bone cement safely after restoration of the physical vertebral height by forming a cavity in the fractured vertebral body in comparison with the conventional vertebroplasty. A clinical study was conducted in Japan to evaluate its efficacy and safety. In addition, results from overseas clinical studies were submitted. |
| Feb 5, 2010 | KYPHON BKP Bone Cement HV-ROrthopedic bone cement | Medtronic Sofamor Danek Co., Ltd. | New device | Apr 1, 2004 | 70 mo later | 651 days | A therapeutic spine bone cement used in percutaneous kyphosis correction in spinal compression fracture performed for restoration of the height of fractured vertebral body, fixation of the vertebral body, and pain relief. The novelty of this product is the capability to fill the bone cement safely after restoration of the physical vertebral height by forming a cavity in the fractured vertebral body in comparison with the conventional vertebroplasty. A clinical study was conducted in Japan to evaluate its efficacy and safety.In addition, results from overseas clinical studies were submitted. |
| Feb 3, 2010 | Hemodialysis Monitoring Equipment TR-3000MAHemodialysis equipment | Toray Medical Co., Ltd. | New device | Not listed | — | 406 days | A hemodialysis monitoring equipment with additional functions to "TR-3000M (Approval No. 21500BZZ00045000),"of assisting priming, blood return, blood taking with diahysate, as well as rapid substitution and manual substitution. Clinical studies were performed in Japan to confirm its efficacy and safety. |
| Feb 2, 2010 | ICLPhakic posterior chamber intraocular lens | STAAR Japan Inc. | New device | Dec 22, 2005 | 49 mo later | 1771 days | An intraocular lens to be implanted in the posterior chamber of the phakic eye (in front of the human crystalline lens) to correct refractive errors in the eye (myopia). |
| Jan 15, 2010 | DefluxFilling material for the treatment of vesicoureteral reflux | Q-Med AB | New device | Sep 24, 2001 | 100 mo later | 703 days | A device with injectable material consisting of dextranomer microspheres which is a bulge forming material and solution of stabilized hyaluronate sodium in phosphate buffered saline filled in a disposable syringe equipped with a tip cap, used for treatment of patients with vesicoureteral reflux grade II - IV. |
| Jan 8, 2010 | XIENCE V Drug Eluting StentCoronary stent | Abbott Vascular Japan Co., Ltd. | New device | Jul 2, 2008 | 18 mo later | 589 days | A drug-eluting coronary stent system with everolimus coating used for dilating and holding a stenotic site of the coronary artery in symptomatic ischemic heart disease. |
| Jan 8, 2010 | PROMUS Drug-Eluting StentCoronary stent | Abbott Vascular Japan Co., Ltd. | New device | Jul 2, 2008 | 18 mo later | 589 days | A drug-eluting coronary stent system with everolimus coating used for dilating and holding a stenotic site of the coronary artery in symptomatic ischemic heart disease. |
| Jan 8, 2010 | Endeavor Sprint Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Oct 2, 2008 | 15 mo later | 283 days | A drug-eluting coronary stent system with zotarolimus coating used for dilating and maintaining the stenotic site of the coronary artery in symptomatic ischemic heart diseases, with a different delivery catheter from the original product. (The original product is in a reexamination period) |
| Jan 8, 2010 | Codman Enterprise VRDProsthetic material for embolization in vessels of the central circulation system | Johnson & Johnson K.K. | New device | May 8, 2007 | 32 mo later | 302 days | A cylindrical, mesh-like vascular reconstruction device to be deployed in the parent artery in order to prevent the embolic coils from protrude and/or dropout into the parent artery during coil embolization of wide-neck intracranial aneurysms, which are difficult to treat with surgery. [Orphan device] |
| Jan 8, 2010 | Vagus Nerve Stimulation (VNS) SystemVagus nerve stimulation device with anti-seizure effects | Nihon Kohden Corporation | New device | Jun 16, 1997 | 151 mo later | 423 days | An electrical stimulation device to stimulate vagus nerve as an adjuvant therapy for patients with drug- resistant epilepsy who have refractory epileptic seizures. Clinical studies were conducted to confirm the efficacy and safety of this product in the target patients. [Priority review] |
| Jan 8, 2010 | Cryosurgical Unit CryoHitVersatile cryosurgical unit | Hitachi Medical Corporation | New device | May 6, 2005 | 56 mo later | 283 days | A cryosurgical system used to kill renal tumor cells of small diameter by utilizing Joule-Thompson effect of high-pressure argon gas to cool the tip end of probe or needle (-100°C or lower) under Magnetic Resonance (MR) Image guidance. |
| Jan 8, 2010 | Cypher Select+ StentCoronary stent | Johnson & Johnson K.K. | New device | Not listed | — | 226 days | A drug-eluting stent coated with drugs to inhibit the neointimal proliferation and a delivery catheter. Clinical studies were conducted to evaluate its efficacy and safety. |
| Dec 24, 2009 | Stryker SpinePlex Bone CementOrthopedic bone cement | Stryker Japan K.K. | New device | May 25, 2004 | 67 mo later | 462 days | An acrylic bone cement used for pain relief in percutaneous vertebroplasty for painful vertebral body fracture caused by malignant spine tumor such as metastatic bone tumor and myeloma which are not responsive to conventional therapies. A clinical evaluation report summarizing the Japanese clinical study results and the literature research data on the use results of this and similar products in foreign countries was submitted to verify the safety and efficacy. [Priority review] |
| Dec 17, 2009 | α Ortho-KOrthokeratology contact lens | Alpha Corporation Inc. | New device | Not listed | — | 28 days | An orthokeratology contact lens for patients with myopia and myopic astigmatism to reshape the corneal anterior surface by wearing it during sleep and correct the unaided vision after removal. (Addition of a brand name to Ortho-K in the reexamination period) (The original product is in a reexamination period) |
| Dec 9, 2009 | Menicon 1day Flat PackSingle-use colored contact lenses for correcting visual acuity | Menicon Co., Ltd. | New device | Not listed | — | 588 days | A daily disposable soft contact lens for myopia and hyperopia. A copolymer of HEMA and GMA is used as lens materials. Clinical studies were conducted to evaluate the efficacy and safety. |
| Dec 2, 2009 | EON Mini Dual 8 NeurostimulatorImplantable stimulator for pain relief | St. Jude Medical Japan Co., Ltd. | New device | Mar 28, 2008 | 20 mo later | 278 days | An implantable stimulator for pain relief to be applied to patients with chronic refractory pain in the trunk and extremities who are not sufficiently responsive to pain relief therapy with drugs or nerve block. It can be charged non-invasively from outside the body. Clinical studies were conducted to evaluate the constant current stimulation that is generally used for electrical tissue stimulation and applied in this product. |
| Nov 20, 2009 | GynemeshNonabsorbable prosthetic material for hernia, chest wall, and abdominal wall | Johnson & Johnson K.K. | New device | Jan 8, 2002 | 94 mo later | 624 days | A mesh used for repair of pelvic organ prolapse, with limited intended use and shape and structure, while manufactured in the same way from the same materials as "Prolene Mesh (polypropylene)" (Approval No. 20400BZY00787000). A clinical evaluation report discussing the efficacy and safety through the defined algorithm for the literature survey was submitted. |
| Nov 20, 2009 | Ultrasound Bone Densitometer LD-100Ultrasound bone densitometer | OYO Electric Co., Ltd. | New device | Not listed | — | 1169 days | A device to measure the bone density using ultrasound. This product calculates the bone density based on the measurement of arrival times and attenuations of fast wave and slow wave that propagate the radius and arrival times of the reflected waves, while conventional ultrasound bone densitometers measure the speed or attenuation of ultrasonic pulse that propagates the calcaneus. Clinical studies were performed in Japan to confirm its efficacy and safety. |
| Nov 18, 2009 | Implantable Ventricular Assist Device HeartMate XVE LVASImplantable ventricular assist device | Nipro Corporation | New device | May 31, 2001 | 102 mo later | 2091 days | An implantable diaphram left ventricular assist device intended for use to improve the circulation in patients with end-stage heart failure who are difficult to survive despite the conventional short-term, mechanically-assisted circulation and maximum medical management, and are considered to be difficult to be rescued without heart transplantation. The efficacy and safety of this product for the target patients were evaluated in the clinical studies using the previous model. [Orphan device] |
| Nov 18, 2009 | da Vinci Surgical SystemSurgical robot, operational unit | Johnson & Johnson K.K. | New device | Apr 29, 2005 | 55 mo later | 331 days | A device to assist a surgeon in controlling endoscopic instruments attached to three arms of the patient cart with master-slave control in order to perform cutting, coagulating and suturing the tissue by manipulating the master controller on the surgeon console. |
| Nov 18, 2009 | EndoWrist Bipolar InstrumentReusable active endotherapy device using radio frequency | Johnson & Johnson K.K. | New device | Apr 29, 2005 | 55 mo later | 331 days | An endoscopic instrument to be connected to "da Vinci Surgical System" to follow the movement of surgeon's hands and wrists by manipulating the master controller intended to work mechanically including grasping,suturing etc.and to cut and coagulate the tissue by using radiofrequency electrosurgery current under endoscopic visualization. |
| Nov 18, 2009 | EndoWrist Monopolar InstrumentReusable active endotherapy device using radio frequency | Johnson & Johnson K.K. | New device | Apr 29, 2005 | 55 mo later | 331 days | An endoscopic instrument to be connected to "da Vinci Surgical System" to follow the movement of surgeon's hands and wrists by manipulating the master controller intended to work mechanically including grasping etc. and to cut and coagulate the tissue by using radiofrequency electrosurgery current under endoscopic visualization. |
| Nov 18, 2009 | EndoWrist InstrumentReusable active endotherapy device | Johnson & Johnson K.K. | New device | Apr 29, 2005 | 55 mo later | 331 days | An endoscopic instrument to be connected to "da Vinci Surgical System" to follow the movement of surgeon's hands and wrists by manipulating the master controller intended to work mechanically including grasping, suturing, ligation etc. under endoscopic visualization. |
| Nov 12, 2009 | Genesis Single 8 NeurostimulatorImplantable stimulator for pain relief | St. Jude Medical Japan Co., Ltd. | New device | Nov 21, 2001 | 96 mo later | 332 days | An implantable stimulator for pain relief to be applied to patients with chronic refractory pain in the trunk and extremities who are not sufficiently responsive to pain relief therapy with drugs or nerve block. Clinical studies were conducted to evaluate the constant current stimulation that is generally used for electrical tissue stimulation and used in this product, while the constant voltage stimulation is used in conventional approved products. |
| Nov 10, 2009 | WallFlex Duodenal StentGastroduodental stent | Boston Scientific Japan K.K. | New device | Dec 4, 2006 | 35 mo later | 375 days | The device consists of a metal stent intended for dilatation and to maintain the patency in gastroduodenal obstructions produced by malignant neoplasms, and a delivery system for endoscopic implantation of the stent. Clinical studies were conducted to evaluate its efficacy for improvement of QOL for a certain period and the safety. |
| Nov 2, 2009 | V.A.C. ATS Therapy SystemNegative Pressure Wound Therapy System | KCI KK | New device | Oct 10, 2003 | 73 mo later | 584 days | A therapy system used for protection of the wounds, maintaining a healing environment, and promoting and shortening the time of wound healing in patients with intractable traumatic wounds or dehisced wounds, post-operative open wounds or skin defect wounds, post-operative wounds after dismemberment of extremities due to diabetics, etc. The novelty of this product is the capability of the system to control the treatment mechanically while the conventional simple suction therapy was performed by individual physicians using a prepared set of tools. A clinical study was conducted in Japan to evaluate its clinical efficacy and safety. |
| Oct 30, 2009 | Medtronic MiniMed CGMS-GoldGlucose monitoring system | Medtronic Japan Co., Ltd. | New device | Jun 15, 1999 | 125 mo later | 1688 days | A glucose monitoring system to keep continuous record of glucose level in the interstitial fluid which is considered to change in parallel with the blood glucose level, intended for use to obtain information on the fluctuation pattern of blood glucose values necessary to optimize the diabetic treatment. A clinical trial was conducted to compare the correlation between the glucose level in blood and that in the interstitial fluid in order to confirm the clinical performance of this product. |
| Oct 28, 2009 | OptiSense SImplantable defibrillator/pacema ker lead | St. Jude Medical Japan Co., Ltd. | New device | May 7, 2007 | 30 mo later | 485 days | A straight transvenous lead to be implanted in the right atrium, used for bradycardia pacing therapy (sensing and pacing). Clinical studies were conducted to evaluate the novel capability of this product to reduce far field sensing in order to inhibit inadequate actuation of the pulse generator (PG). |
| Oct 28, 2009 | OptiSense OptimImplantable defibrillator/ pacemaker lead | St. Jude Medical Japan Co., Ltd. | New device | Oct 1, 2009 | 1 mo later | 485 days | A straight transvenous lead to be implanted in the right atrium, used for bradycardia pacing therapy (sensing and pacing). Clinical studies were conducted to evaluate the novel capability of this product to reduce far field sensing in order to inhibit inadequate actuation of the PG. |
| Oct 28, 2009 | OptiSense Optim LeadImplantable defibrillator/ pacemaker lead | Fukuda Denshi Co., Ltd. | New device | Oct 1, 2009 | 1 mo later | 467 days | A straight transvenous lead to be implanted in the right atrium, used for bradycardia pacing therapy (sensing and pacing). Clinical studies were conducted to evaluate the novel capability of this product to reduce far field sensing in order to inhibit inadequate actuation of the PG. |
| Oct 19, 2009 | Cool Path Duo Irrigation CatheterCardiovascular ablation catheter | St. Jude Medical Japan Co., Ltd. | New device | Not listed | — | 327 days | An electrode catheter used for the electrophysiological study of the heart and for creating endocardial lesions to treat typical atrial flutter with radiofrequency current. Clinical studies were conducted to evaluate the novel irrigation feature of this product that allows saline flushing from the tip electrode to avoid increasing tip electrode-tissue interface temperature. |
| Sep 1, 2009 | MR-Guided Focused Ultrasound Surgery System ExAblate 2000Ultrasound hyperthermia system | GE Healthcare Japan Corporation | New device | Oct 22, 2004 | 58 mo later | 679 days | A focused ultrosonic surgery system used for treatment of symptomatic uterine fibroid while monitoring the tissue temperature with MR in order to improve the symptoms. |
| Aug 21, 2009 | DuraSeal Blue SprayAbsorbable tissue reinforcement material | Tyco Healthcare Japan Inc. | New device | Apr 7, 2005 | 52 mo later | 549 days | An absorbable prosthetic material for dura mater applied as an adjunct to suturing, on the dural gap, sutured site of dura mater, and the gap between the duraplasty material and dura mater. A clinical study was conducted to evaluate its efficacy and safety. |
| Aug 10, 2009 | Cool Path Ablation SystemCardiovascular ablation catheter | St. Jude Medical Japan Co., Ltd. | New device | Mar 16, 2007 | 29 mo later | 510 days | An electrode catheter used for the electrophysiological study of the heart and for creating endocardial lesions to treat typical atrial flutter with radiofrequency current. Clinical studies were conducted to evaluate the novel irrigation feature of this product that allows saline flushing from the tip electrode to avoid increasing tip electrode-tissue interface temperature. |
| Aug 6, 2009 | HydroCoil Embolic SystemSterilized tube and catheter for vascular treatment | Terumo Corporation | New device | Jul 29, 2002 | 84 mo later | 1989 days | A delivery pusher for platinum alloy coil intended to block the blood flow into brain aneurysm and for guiding the coil to the implanting site. The coil is coated with swellable hydrogel. Clinical evaluation data to evaluate its efficacy and safety were submitted. |
| Aug 6, 2009 | Blend-EArtificial knee joint, patellar and tibial component | Nakashima Medical Co., Ltd. | New device | Not listed | — | 934 days | A tibial insert and patellar component made from ultrahigh molecular weight polyethylene. The shape and structure are the same as the approved products of the company, but dl-α-Tocopherol, a kind of vitamin E, has been added to this product in order to give the antioxidative potential to the material and to improve the resistance to wear. Clinical studies were performed in Japan to confirm its efficacy and safety. |
| Aug 5, 2009 | Altrua 60DRImplantable cardiac pacemaker | Boston Scientific Japan K.K. | New device | Apr 23, 2008 | 15 mo later | 383 days | Dual-chamber implantable cardiac pacemaker. A clinical study was conducted to evaluate its Automatic Capture feature capability, which automatically adjusts the ventricular pacing output. |
| Aug 5, 2009 | Altrua 60SRImplantable cardiac pacemaker | Boston Scientific Japan K.K. | New device | Apr 23, 2008 | 15 mo later | 352 days | Dual-chamber implantable cardiac pacemaker. A clinical study was conducted to evaluate its Automatic Capture feature capability, which automatically adjusts the ventricular pacing output. |
| Jul 24, 2009 | Relieva Sinus Balloon Catheter SetEndoscopic dilatation catheter | Medico's Hirata Inc. | New device | Apr 5, 2005 | 52 mo later | 401 days | A catheter set used to drain the pus by dilating narrowed natural openings of the frontal sinus, sphenoid sinus, and maxillary sinus with balloons for the treatment of sinusitis. A clinical evaluation report based on the overseas post-marketing clinical research was submitted to evaluate its efficacy and safety. |
| Jul 7, 2009 | Endo-PAT2000Regional body plethysmograph | CCI Corporation | New device | Nov 12, 2003 | 68 mo later | 439 days | A device to determine the vascular endothelium- mediated changes by measuring the volume pulse waves before and after 5-minute occlusion of the brachial artery with a cuff applied on the upper arm. Overseas clinical study results were used to evaluate the safety. |
| Jul 1, 2009 | VISX Excimer Laser SystemOphthalmic laser corneal surgical instrument | AMO Japan K.K. | New device | May 23, 2003 | 73 mo later | 96 days | An excimer laser surgical system used in ophthalmology to correct myopia or astigmatism and remove corneal opacities by laser ablation of corneal tissue. (Application for change from a foreign exceptional approval to a regular marketing approval in the reexamination period) |
| Jun 29, 2009 | OIC PEEK Interbody CageSpinal cage | Stryker Japan K.K. | New device | Aug 5, 2004 | 59 mo later | 732 days | A spinal cage made from a novel material polyetheretherketone (PEEK) resin. A pair of these products with bone graft packed inside are intervertebrally inserted and fixed by pressure using another intervertebral fixation system. Clinical studies were performed in Japan to confirm its efficacy and safety. |
| Jun 8, 2009 | Fuji IRHygienic products 2 Contraceptive condom for males | Fuji Latex Co., Ltd. | New device | Not listed | — | 619 days | A condom made chiefly from polyisoprene rubber used to cover the penis for the purpose of contraception and as an adjunct in the prevention of sexually transmitted diseases. A clinical study was conducted to compare its efficacy and safety with those of commercially available condoms (condom made from natural rubber latex). |
| Jun 2, 2009 | MonosynPolyglyconate suture | B. Braun Aesculap Japan Co., Ltd. | New device | Jun 29, 2001 | 95 mo later | 736 days | An absorbable synthetic monofilament suture made of glycolide/trimethylene carbonate/ε-caprolactone. A clinical trial was conducted to evaluate the efficacy and safety because the combination and amount of the polymers are different from the precedented approved product's. |
| May 22, 2009 | Allegretto WaveOphthalmic laser corneal surgical instrument | Wavelight Laser Technologie AG | New device | Oct 17, 2003 | 67 mo later | 1669 days | An excimer laser surgical system used in ophthalmology to correct myopia or astigmatism by laser ablation of corneal tissue. (The original product is in a reexamination period) |
| May 8, 2009 | Care Sheet "SS"Hydrocolloid material | SSP Co., Ltd. | New device | Not listed | — | 2907 days | A wound dressing and protecting material using hydrogel in a form of poultice. A clinical study was conducted to evaluate its efficacy and safety. |
| Apr 28, 2009 | Ortho-KOrthokeratology contact lens | Alpha Corporation Inc. | New device | Not listed | — | 876 days | The first orthokeratology contact lens in Japan for patients with myopia and myopic astigmatism to reshape the corneal anterior surface by wearing it during sleep and correct unaided vision after removal of the lens. |
| Apr 24, 2009 | Promote RF 30Implantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Sep 11, 2007 | 19 mo later | 238 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. The function to set the pacing timing was evaluated in the clinical study. |
| Apr 20, 2009 | Palmaz Genesis for Renal ArteryStent for blood vessel | Johnson & Johnson K.K. | New device | Not listed | — | 641 days | A stent used for dilating and holding a stenotic site in renal artery stenosis. Clinical studies were conducted to evaluate its clinical efficacy in renal artery stenosis. |
| Apr 16, 2009 | Promote 36Implantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | May 7, 2007 | 23 mo later | 533 days | An implantable pulse generator that delivers CRT (treatment method to improve cardiac failure symptoms, which synchronizes ventricular contraction by stimulating cardiac muscles of both ventricles electrically for a long time), with the function of a defibrillator. The function to set the pacing timing was evaluated in the clinical study. |
| Apr 16, 2009 | Promote RF 36Implantable biventricular pacing pulse generator with defibrillator function | St. Jude Medical Japan Co., Ltd. | New device | Sep 11, 2007 | 19 mo later | 533 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. The function to set the pacing timing was evaluated in the clinical study. |
| Apr 9, 2009 | TALENT Thoracic Stent Graft SystemAortic stent graft | Medtronic Japan Co., Ltd. | New device | Jun 5, 2008 | 10 mo later | 714 days | A stent graft for thoracic aortic aneurysms used to prevent blood flow into the aneurysm and aneurysm rupture. (The original product is in a reexamination period) |
| Mar 30, 2009 | CRT-P (Fukuda Denshi Co.,Implantable biventricular pacing pulse generator without defibrillator function | Not listed | New device | Apr 29, 2005 | 47 mo later | 364 days | An implantable pulse generator that delivers CRT. Optimization of interventricular timing of biventricular pacing therapy was evaluated in the clinical studies. |
| Mar 24, 2009 | Endeavor Coronary Stent SystemCoronary stent | Medtronic Japan Co., Ltd. | New device | Feb 1, 2008 | 14 mo later | 685 days | A drug-eluting coronary stent system with zotarolimus coating to be used for dilating and holding the stenotic site of the coronary artery in symptomatic ischemic heart diseases. |
| Mar 24, 2009 | IIImplantable biventricular pacing pulse generator without defibrillator function | St. Jude Medical Japan Ltd. | New device | Apr 29, 2005 | 47 mo later | 358 days | An implantable pulse generator that delivers CRT. Optimization of interventricular timing of biventricular pacing therapy was evaluated in the clinical studies. |
| Mar 24, 2009 | SR+ (Fukuda Denshi Co.,Implantable cardiac pacemaker | Not listed | New device | Not listed | — | 397 days | A single chamber implantable cardiac pacemaker. Its ventricular autocapture algorithm was modified to reduce the possibility of the misdetection of electrochemical polarization voltage that occurs in the conventional product. Clinical studies were conducted chiefly to evaluate the modified algorithm. |
| Mar 24, 2009 | DR+ (Fukuda Denshi Co.,Implantable cardiac pacemaker | Not listed | New device | Not listed | — | 397 days | A dual chamber implantable cardiac pacemaker. Its ventricular autocapture algorithm was modified to reduce the possibility of the misdetection of electrochemical polarization voltage that occurs in the conventional product. Clinical studies were conducted chiefly to evaluate the modified algorithm. |
| Mar 23, 2009 | XArtificial bone implant | MMT Co., Ltd. | New device | Not listed | — | 682 days | A composite type of synthetic hydroxyapatite bone substitute made of interconnected porous and solid parts. The product is used with the inner and outer fixation devices at the load bearing site. Clinical studies were conducted to evaluate its efficacy and safety in patients with cortical bone defect. |
| Mar 17, 2009 | DRImplantable cardiac pacemaker | St. Jude Medical Japan Ltd. | New device | Not listed | — | 404 days | A dual-chamber implantable cardiac pacemaker. Its ventricular autocapture algorithm was modified to reduce the possibility of the misdetection of electrochemical polarization voltage that occurs in the conventional product. Clinical studies were conducted chiefly to evaluate the modified algorithm. |
| Mar 17, 2009 | SRImplantable cardiac pacemaker | St. Jude Medical Japan Ltd. | New device | Not listed | — | 404 days | A single-chamber implantable cardiac pacemaker. Its ventricular autocapture algorithm was modified to reduce the possibility of the misdetection of electrochemical polarization voltage that occurs in the conventional product. Clinical studies were conducted chiefly to evaluate the modified algorithm. |
| Feb 10, 2009 | StarFix Lead Japan Co.,Implantable defibrillator/ pacemaker lead | Not listed | New device | Jun 13, 2008 | 8 mo later | 215 days | An over-the-wire (OTW) type of left ventricular lead used with implantable pulse generators such as CRT-D for CRT. The documents on clinical studies were submitted for evaluation of the efficacy and safety of this product. |
| Jan 29, 2009 | HA ImplantIntraosseous dental implant | Yamahachi Dental Co. | New device | Not listed | — | 427 days | An intraosseous dental implant made of titanium with a hydroxyapatite (HA) coating (1 - 2 μm). Clinical studies were conducted to evaluate the efficacy and safety of this product coated with HA. |
| Jan 28, 2009 | Taxus Libertè Stent SystemCoronary stent | Boston Scientific Japan K.K. | New device | Oct 10, 2008 | 4 mo later | 303 days | A drug-eluting coronary stent system with paclitaxel coating to be used for dilating and holding a stenotic site of the coronary artery in symptomatic ischemic heart disease. (The original product is in a reexamination period) |
| Dec 26, 2008 | PDA Occlusion SetProsthetic material for embolization in vessels of the central circulation system | Japan Lifeline Co., Ltd. | New device | May 14, 2003 | 67 mo later | 848 days | The first device in Japan dedicated for the closure of patent ductus arteriosus (PDA) by the deployment of the duct occluder in the PDA site percutaneously using the delivery system. |
| Dec 22, 2008 | VEPTR SystemInternal fixation system | Synthes K. K. | New device | Aug 18, 2004 | 52 mo later | 208 days | An implantable device made of standard medical grade titanium to be used in patients with thoracic insufficiency syndrome to stabilize their thorax while correcting chest wall malformations in order to help the growth of their thorax and lungs. [Priority review] |
| Dec 18, 2008 | StarSlow continuous hemofilter | JMS Co., Ltd. | New device | Not listed | — | 875 days | A hemofilter used for treatment and purification of body fluid in patients with acute renal failure accompanying acute hepatic insufficiency, acute on chronic renal failure, perioperative period, sepsis, multiple organ failure, acute respiratory failure, or acute circulation failure. Clinical studies were conducted because it was the first time to use polyethersulfone (PES) as a raw material of hollow fibers. |
| Dec 15, 2008 | Thermocool & JohnsonCardiovascular ablation catheter | Not listed | New device | Nov 5, 2004 | 49 mo later | 410 days | An electrode catheter used in myocardium with radiofrequency current and for the electrophysiological study of the heart to treat type I atrial flutter. Clinical studies were conducted to evaluate the novel irrigation feature of this product that allows saline flushing from the tip electrode to aviod increasing tip electrode-tissue interface temperature. |
| Nov 28, 2008 | 1-Piece IOLPosterior chamber lens | AMO Japan K. K. | New device | Oct 30, 2007 | 13 mo later | 561 days | An one-piece intraocular lens utilizes the raw materials of the optical zone of the existing intraocular lens in the haptic zone as well. Clinical studies were conducted to evaluate the efficacy and safety of this product including the performance of the haptic zone. |
| Oct 31, 2008 | Day (CooperVision Japan,Single use colored contact lenses for correcting visual acuity | Not listed | New device | Nov 22, 2006 | 23 mo later | 283 days | A daily disposable soft contact lens for myopia, hyperopia, astigmatism, or presbyopia. A copolymer of HEMA and MPC is used as lens material. A clinical study was conducted to evaluate the efficacy and safety of this product. |
| Sep 26, 2008 | ONYX Liquid Embolic System LDOther tube and catheter related auxiliary devices (vascular embolization system) | ev3, K.K. | New device | Jul 21, 2005 | 38 mo later | 1276 days | The first liquid embolic material in Japan used to occlude the flow of blood as pretreatment for surgical resection of arteriovenous malformations(bAVM’s). [Priority review] |
| Sep 8, 2008 | Olympus Capsule Endoscope SystemCapsule electronic endoscope system | Olympus Medical Systems Corp. | New device | Sep 14, 2007 | 12 mo later | 602 days | An endoscopic system comprised of a capsule endoscope (26 x 11 mm) and a monitoring unit. To be used for monitoring and diagnosis of the small bowel. (The original product is in a reexamination period) |
| Sep 8, 2008 | & Lomb SystemElectric keratome | Bausch & Lomb Japan Ltd. | New device | Mar 22, 2004 | 54 mo later | 992 days | An electric keratome used in ophthalmic surgeries such as laser in-situ keratomileusis (LASIK) for lamellar corneal incisions. A clinical study was conducted to evaluate the safety of this product in LASIK. |
| Aug 25, 2008 | AH (Senko Medical TradingBioresorbable local hemostatic device | Not listed | New device | Sep 26, 2006 | 23 mo later | 858 days | An absorbable hemostat consisting of microporous polysaccharide hemospheres (MPHs) to be used for the local management of bleeding wounds. Clinical studies were conducted to evaluate the hematostatic ability and safety of this product compared with a similar product. |
| Aug 5, 2008 | AcrySof Toric Piece Japan Ltd.)Posterior chamber lens | Not listed | New device | Sep 14, 2005 | 35 mo later | 594 days | An intraocular lens with its posterior face having a cylindrical optical power for correcting corneal astigmatism. Clinical studies were conducted to evaluate the efficacy and safety of this astigmatic (toric) intraocular lens. |
| Aug 5, 2008 | Multifocal IOLMultifocal posterior chamber lens | AMO JAPAN K. K. | New device | Not listed | — | 461 days | A multifocal intraocular lens with its anterior face having an aspheric mechanism and the posterior face having a diffractive multifocal mechanism. Clinical studies were conducted to evaluate the efficacy and safety of this multifocal intraocular lens. |
| Jul 16, 2008 | Ability Lead Japan Co.,Implantable defibrillator/ pacemaker lead | Not listed | New device | Apr 7, 2009 | 9 mo earlier | 181 days | Over-the-wire (OTW) type of left ventricular lead used with implantable pulse generators such as cardiac resynchronization therapy defibrillator (CRT-D). The documents on clinical studies were submitted for evaluation of the efficacy and safety of this product. |
| Jul 16, 2008 | HF-T (BIOTRONIK Japan,Implantable biventricular pacing pulse generator with defibrillator function | Not listed | New device | Dec 7, 2006 | 19 mo later | 166 days | An implantable pulse generator that delivers cardiac resynchronization therapy (CRT), with the function of a defibrillator. The documents on clinical studies were submitted for evaluation of the efficacy and safety of this product. |
| Jul 16, 2008 | HF-T (BIOTRONIK Japan,Implantable biventricular pacing pulse generator with defibrillator function | Not listed | New device | Dec 7, 2006 | 19 mo later | 166 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. The documents on clinical studies were submitted for evaluation of the efficacy and safety of this product. |
| Jul 11, 2008 | Medtronic Reveal DX Japan Co.,ECG monitor | Not listed | New device | Nov 21, 2007 | 8 mo later | 280 days | An insertable cardiac monitor to be implanted under the skin in patients for whom the diagnosis was not made from the test(s) the physician considered necessary. The device is intended for use in patients with unexplained syncope for the purpose of recording and storing the ECGs for diagnosis. The documents on clinical evaluation were submitted concerning the efficacy and safety of electrocardiography using this product. |
| Jul 4, 2008 | Mini Vision Stent SystemCoronary stent | Abbott Vascular Japan Ltd. | New device | Sep 10, 2004 | 46 mo later | 463 days | A coronary stent for reference vessel diameters ranging from 2.25 mm to 2.5 mm.Clinical trials were conducted to evaluate the efficacy and safety of the stent for bailout use in small vessels. |
| Jul 1, 2008 | Excimer Laser Cardiac Lead Removal SystemPacemaker / defibrillator lead extraction kit | DVx Inc. | New device | Dec 9, 1997 | 127 mo later | 489 days | The first extraction laser sheath in Japan used at removal of chronically implanted pacing or defibrillator leads to ablate binding tissue around the circumference of leads using the laser energy delivered from the dedicated excimer laser system. [Priority review] |
| May 22, 2008 | Dermal TemplateOther surgical or orthopedic materials (dermal regeneration graft) | Century Medical, Inc. | New device | Mar 1, 1996 | 147 mo later | 2586 days | A two-layered matrix consisting of a cross-linking layer of bovine-derived collagen and shark-derived glycosaminoglycan and a silicone layer. To be indicated for the postexcisional treatment of full-thickness or partial- thickness thermal injuries. The product contains glycosaminoglycan, which is a novel feature unseen in existing products. Clinical studies were conducted to evaluate the efficacy and safety of this product. |
| May 7, 2008 | Consulta CRT-DImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd | New device | Mar 17, 2008 | 2 mo later | 138 days | An implantable pulse generator that delivers CRT, with the function of a defibrillator. (The original product is in a reexamination period) |
| May 7, 2008 | Hollow FiberHemodiafilter | Asahi Kasei Medical Ltd. | New device | Not listed | — | 894 days | A hemodialfilter using hollow fibers made of polysulfone resin to remove metabolites in blood during hemodiafiltration for patients with acute and chronic renal failure. Clinical studies were conducted because it was the first time to use polysulfone resin as a raw material of hollow fibers for hemodialfilter, although it had been approved for hemodialyzer. |
| Apr 9, 2008 | Excimer Laser System MEL80Other laser surgical instrument and laser coagulator (ophthalmic excimer laser surgical instrument) | Carl Zeiss Meditec Co., Ltd. | New device | Aug 11, 2006 | 20 mo later | 1107 days | An excimer laser surgical system used in ophthalmology to correct myopia or astigmatism by laser ablation of corneal tissue. (The original product is in a reexamination period) |
| Mar 25, 2008 | Dornier Epos UltraOther therapeutic or surgical instruments (electromagnetic induction-type extracorporeal shock wave therapy system) | Dornier MedTech Japan Co., Ltd. | New device | Not listed | — | 2281 days | A low-energy extracorporeal shock wave therapy system for orthopedic use. This is the first device in Japan to relieve the pain of chronic plantar fasciitis with reduced output of the conventional electromagnetic induction-type extracorporeal shock wave lithotripter. |
| Mar 25, 2008 | HOYA Airy One monthReusable colored contact lens for correction of visual acuity | HOYA Corporation | New device | Not listed | — | 795 days | Silicone hydrogel soft contact lenses made of a new silicone-containing monomer that are indicated for daily or up to 30-day extended wear. Lenticular lens designs were used. Clinical studies were mainly conducted to evaluate the safety of the lenses made of a new raw material. |
| Mar 12, 2008 | GORE TAG Thoracic Endoprosthesis SystemAortic stent graft | Japan Gore-Tex Inc. | New device | Not listed | — | 492 days | The first stent graft for thoracic aortic aneurysm in Japan to prevent the blood flow into the aneurysm and its rupture. The incidence of adverse events after treatment was evaluated in a clinical study comparing with surgical therapy. [Priority review] |
| Mar 6, 2008 | Technolas Excimer Laser SystemOther laser surgical instrument and laser coagulator (ophthalmic excimer laser surgical instrument) | Bausch & Lomb Japan Co., Ltd. | New device | Not listed | — | 1742 days | An excimer laser surgical system used in ophthalmology to correct myopia or astigmatism by laser ablation of corneal tissue. (The original product is in a reexamination period) |
| Mar 3, 2008 | Cataract Surgery INFINITI Vision SystemCataract and vitreous surgery instrument | Alcon Japan Ltd. | New device | Not listed | — | 987 days | A surgical system used for extracapsular cataract extraction and anterior vitrectomy that performs various functions such as irrigation, aspiration, phacoemulsification, vitrectomy, and cauterization or coagulation. This product is a system that adds the AquaLase function which delivers balanced saline solution (BSS) to fragment cataracts with fluidic pulses to the approved Ultrasonic Cataract Surgery INFINITI Vision System (approval No. 21500BZY00342000). Because the AquaLase function was introduced for the first time in Japan, clinical studies were conducted to evaluate its clinical use. |
| Feb 28, 2008 | Menicon LifelyReusable colored contact lenses for correction of visual acuity | Menicon Co., Ltd. | New device | Not listed | — | 76 days | Oxygen-permeable hard contact lenses, which are indicated for daily or up to 30-day extended wear (trade name divisional application of Menicon Tinu, the original product). (The original product is in a reexamination period) |
| Feb 26, 2008 | ACUITY SteerableImplantable defibrillator/pacema ker lead | Boston Scientific Japan K.K. | New device | Not listed | — | 333 days | OTW(Over-The-Wire) type of left ventricular lead used with implantable pulse generators such as CRT-D in CRT(Cardiac Resynchronization Therapy). (The original product is in a reexamination period) |
| Feb 25, 2008 | HiResolution Bionic Ear SystemOther sensory assisting instrument (cochlear implant system) | Nihon Bionics Co., Ltd. | New device | Not listed | — | 1083 days | A cochlear implant system with a new sound processing strategy (HiRes) with higher stimulation rates. Clinical studies were mainly conducted to evaluate the efficacy of HiRes and the safety of this implant whose material and shape differ from those of the conventional product. |
| Feb 5, 2008 | Powerlink Stent Graft SystemAortic stent graft - | Cosmotec Co., Ltd. | New device | Not listed | — | 736 days | A stent graft for abdominal aortic aneurysm to prevent blood flow into the aneurysm and its rupture. The incidence of adverse events after treatment was mainly evaluated in clinical studies. (The original product is in a reexamination period) |
| Feb 5, 2008 | O OPTIX 2- 2 WeekReusable colored contact lenses for correction of visual acuity | CIBA VISION K.K. | New device | Not listed | — | 427 days | Soft contact lenses indicated for daily or up to 2-week extended wear, made of a new raw material, silicone hydrogel, with a new combination of the raw materials used in the approved product O OPTIX (approval no., 2 21600BZY00383000) for higher water content. Both spherical and toric lens designs were used. Because a new raw material is used, comparative clinical studies were conducted to evaluate the safety of this product. |
| Jan 23, 2008 | Noninvasive Hemoglobin Analyzer R02MOther single- person bioinformation monitor and related instruments (noninvasive hemoglobin analyzer) - 119 | Sysmex Corporation | New device | Not listed | — | 1784 days | This device irradiates a finger with infrared to near-infrared light and noninvasively measures the amount of light absorption by hemoglobin in the peripheral blood. The pulse oxymeter uses a similar principle to show the oxygen saturation in the arterial blood, whereas the new device is intended for use in screening for severe and moderate anemia and uses a new indicator correlating with blood hemoglobin concentration to show hemoglobin levels in five levels. Clinical studies were conducted to evaluate whether it can be used in screening for anemia as an indicator of hemoglobin levels. - |
| Jan 18, 2008 | AngioSculpt PTCA Balloon CatheterBalloon- expandable catheter for coronary angioplasty | USCI Japan Ltd. | New device | Not listed | — | 505 days | A PTCA balloon catheter with a wire outside the balloon to reduce the slipping on expansion. The slipping-reducing effect and safety of the improved product were evaluated in clinical studies. |
| Dec 7, 2007 | Concerto C174AWKImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd. | New device | Not listed | — | 308 days | Implantable pulse generator that delivers CRT, with function of defibrillator. (The original product is in a reexamination period) |
| Nov 21, 2007 | Medtronic Virtuoso DRDual-chamber automatic implantable defibrillator - 118 | Medtronic Japan Co., Ltd. | New device | Not listed | — | 307 days | Ｉmplantable defibrillator used to automatically detect and treat atrial fibrillation/tachycardia and ventricular fibrillation/tachycardia. Clinical study results were submitted to evaluate the MVP function (to give priority to self atrioventricular conduction and inhibit unnecessary ventricular pacing), atrial cardioversion function, and atrial antitachycardia pacing function. - |
| Nov 21, 2007 | Sterile CFRP CageBone setting assembly | Medtronic Sofamor Danek, Co., Ltd. | New device | Not listed | — | 1274 days | A spinal cage made of a carbon fiber-reinforced polymer (CFRP). Because the material used in this product is different from that in the approved product, which is made of a titanium alloy, clinical studies were conducted to evaluate whether the product is effective and safe for clinical use. |
| Nov 7, 2007 | Toraysulfone HDFHemodialysis filter | Toray Industries, Inc. | New device | Not listed | — | 854 days | A hemodiafilter using hollow fibers made of polysulfone resin to remove metabolites (including urea, creatinine, water, etc.) in blood during hemodiafiltration for patients with acute and chronic renal failure. Clinical investigation was conducted to evaluate its efficacy and safety because it was the first time that polysulfone resin was used as a raw material of hollow fibers of hemodiafilter. |
| Oct 31, 2007 | SEAMDURA, NEOSEAMBioabsorbable artificial dural substitutes | GUNZE Limited | New device | Not listed | — | 2638 days | The first bioabsorbable artificial dural substitutes in Japan to compensate for the dural defect. Their clinical performance as dural substitutes was evaluated in clinical studies. |
| Oct 29, 2007 | JACEOther surgical/orthopedic materials (autologous cultured epidermis) - | Japan Tissue Engineering Co., Ltd. | New device | Not listed | — | 540 days | Autologous cultured keratinocytes using Green’s technique in which keratinocytes derived from the patient's own skin tissue are co-cultured with irradiated 3T3-J2 cells derived from mouse fetuses as a feeder to form a sheet in approximately three to seven layers thick. This is indicated for the treatment of serious large burns that cannot be provided with a sufficient area of donor skin for autologous skin grafting, and of burns in which the total area of deep second-degree (deep dermal) and third-degree (full-thickness) burn is 30% or more of the total body surface area. It is the first medical device of processed human cellullar/tissue product in Japan. [Priority review] |
| Oct 23, 2007 | NSE PTCA Balloon CatheterBalloon- expandable catheter for coronary angioplasty | Goodman Co., Ltd. | New device | Not listed | — | 337 days | A device in which slipping on balloon expansion is reduced by placing elements along the balloon of the PTCA balloon catheter. Clinical studies were conducted to evaluate the slipping-reducing effect of this product and the safety of the elements. |
| Oct 1, 2007 | Excimer Laser Corneal Surgery System EC- 5000CXIIIOphthalmic laser corneal surgical instrument | Nidek Co., Ltd. | New device | Not listed | — | 458 days | An excimer laser surgical system used in ophthalmology to correct myopia or astigmatism, remove corneal surface opacities, and smooth corneal irregularities by laser ablation of corneal tissue. (The original product is in a reexamination period) |
| Oct 1, 2007 | Navistar DSCardiovascular ablation catheter | Johnson & Johnson K.K. | New device | Not listed | — | 579 days | An electrode catheter used in myocardial with radiofrequency current and for the electrophysiological examination of the heart to treat type I atrial flutter. It has one 8-mm tip electrode, two temperature sensors, and a maximum power output of 70 W. Clinical studies were conducted because both the electrode length and output in this product is different from that in the conventional product. |
| Oct 1, 2007 | Aquacel AgAntimicrobial material | Bristol-Myers Squibb K.K. | New device | Not listed | — | 1084 days | An antimicrobial dressing consisting of 100% fibrous sodium carboxymethylcellulose and silver used to protect wounds deep into the subcutaneous fat tissue, while maintaining a moist environment, promoting healing, and relieving pain. Expected secondary effects include antimicrobial effect of the silver ion on the bacteria existing inside the dressing and at the wound contact area. Clinical studies were conducted to evaluate the antimicrobial activity, wound-healing effect, and safety of this product. |
| Sep 28, 2007 | ANGIOGUARD XPEmboli-capturing catheter in the central circulatory system | Johnson & Johnson K.K. | New device | Not listed | — | 457 days | The first device in Japan to prevent distal emboli with a polyurethane filter to capture and remove embolic substances including thrombi released while a stent is placed in the carotid artery. The effect on the prevention of distal embolization with the use of the stent and the operability were evaluated in clinical studies. [Priority review] |
| Sep 28, 2007 | PRECISE for the Carotid ArteryStent for the carotid artery | Johnson & Johnson K.K. | New device | Not listed | — | 457 days | The first stent for the carotid artery in Japan to dilate carotid stenosis and prevent restenosis.The incidence of complications after treatment was evaluated in a clinical study comparing with surgical therapy. [Priority review] |
| Sep 28, 2007 | Intravascular OCT ImageWireIntravascular optical tomographic catheter | Goodman Co., Ltd. | New device | Not listed | — | — | An intravascular optical tomographic catheter that irradiates the vascular wall with near infrared light through internal optical fibers and images for testing the lumens and superficial walls of the coronary arteries by optical coherence tomography (OCT). This is the first medical device in Japan to use OCT for intravascular observation. |
| Sep 28, 2007 | Intravascular OCT Imaging SystemOCT diagnostic imaging instrument - | Goodman Co., Ltd. | New device | Not listed | — | 605 days | A diagnostic imaging system using near infrared light as a light source that images for testing the lumens and superficial walls of the coronary arteries by OCT. This is the first medical device in Japan to use OCT for intravascular observation. |
| Sep 7, 2007 | SynchroMed II PumpProgrammable implantable drug infusion pump | Medtronic Japan Co., Ltd. | New device | Not listed | — | 309 days | Drug infusion pump indicated for intrathecal baclofen therapy. (The original product is in a reexamination period) |
| Aug 3, 2007 | K-MAX AHT HIP SystemHip prosthesis | Japan Medical Materials Corporation | New device | Not listed | — | 855 days | A system consisting of a titanium alloy stem, an outer cup (both cementless), and screws used for the total hip replacement, partial hip replacement, etc. The proximal portion of the stem and the surface of the outer cup are subjected to surface roughening by spraying pure titanium followed by alkaline heat treatment, and the screw heads are subjected to alkaline heat treatment. Because of the novelty of the surface treatment employed, clinical studies were conducted to evaluate whether this product is effective and safe for clinical use. |
| Jul 26, 2007 | RevolutionIntravascular ultrasonic catheter for the central circulatory system | Goodman Co., Ltd. | New device | Not listed | — | 437 days | A catheter for intravascular ultrasonic diagnostic imaging that incorporates an ultrasonic transducer for ultrasound imaging of the vascular lumen and wall. The ultrasonic frequency was improved to 45 MHz. Clinical results were submitted mainly to evaluate the adverse events associated with the use of this system. |
| Jul 26, 2007 | Volcano In- Vision Gold Imaging SystemCardiovascular ultrasonic diagnostic imaging instrument | Goodman Co., Ltd. | New device | Not listed | — | 437 days | A diagnostic imaging instrument intended to image and test the vascular lumen and wall using ultrasound. The ultrasonic frequency has been improved to 45 MHz. Clinical studies were mainly conducted to evaluate the adverse events associated with the use of this system. |
| Jul 11, 2007 | Express LD Vascular StentStent for iliac arteries - 117 | Boston Scientific Japan Co., Ltd. | New device | Not listed | — | 378 days | A balloon-expandable stent for iliac arteries. Delivery of this stent is easier because the delivery catheter of this stent has a smaller diameter than those of the conventional products of other companies. The clinical performance (including restenosis rate) of the stent was evaluated in clinical studies. - |
| Jul 9, 2007 | IBI Cardiac Ablation System IIMedical cautery instrument | Getz Bros Co., Ltd. | New device | Not listed | — | 830 days | An instrument that electrophysiologically detects the abnormal conduction pathways in the heart with arrhythmia and that ablates these pathways. Major improvements in this product as compared to the conventional product include two temperature sensors for the ablation site to ensure safety and the ability increase the output up to 100 W. Clinical studies were conducted to evaluate the safety of the increased output. |
| Jun 28, 2007 | Moistear and 5 other trade namesOther ophthalmic products and related products (punctal plug) | Koken Co., Ltd | New device | Not listed | — | 1651 days | A punctal plug made of atelocollagen to retain tear volume by lacrimal duct occlusion as a symptomatic treatment for aqueous tear deficiency (dry eye). Unlike the conventional silicone plug, the atelocollagen solution is the first medical device intended to achieve embolization by gelatinizing the solution injected into the lacrimal duct at body temperature. Clinical studies were conducted to evaluate the efficacy of this product and the safety of atelocollagen in the eyes. |
| Jun 19, 2007 | Alcon AcrySof ReSTOR Single-PieceInstrument and apparatus 72 Multifocal posterior chamber lens | Alcon Japan Ltd. | New device | Not listed | — | 627 days | Foldable multifocal posterior chamber lens with 12 toric diffraction regions in the anterior center. A new lens design with a diffraction structure that diffracts the incident light into near and far fields is used, and the lens has two focal points. Clinical studies were conducted to evaluate whether the structure provides the expected performance, efficacy, and safety of this product. |
| Jun 11, 2007 | LactoSorbBone setting assembly | Biomet Microfixation, Inc. | New device | Not listed | — | 1200 days | An absorbable bone setting assembly made of the copolymer of L-lactate and glycolate. This product was given overseas manufacturing approval as screws, plates, and mesh used for bone setting and reconstruction to treat cranial and facial bone trauma. The improvement in this device is that an absorbable coplymer which has not yet been approved for use as a raw material is used as the raw material. Clinical studies were conducted to evaluate whether the absorption rate of this product is safe for clinical use. |
| Jun 7, 2007 | Angio-Seal STS PLUSBioresorbable local hemostatic device | Getz Bros. Co., Ltd. [Japan] | New device | Not listed | — | 1224 days | A device to achieve hemostasis at the femoral artery puncture site after percutaneous catheterization by sandwiching the vascular wall between the anchor from the inside of the punctured vascular wall and the collagen sponge and bioresorbable suture from the outside. This product improves ease of use and suture knotting than the conventional product. Clinical studies were mainly conducted to evaluate whether the device has a hemostatic effect comparable to that of the conventional product. |
| Jun 4, 2007 | Sleep Recorder SD-101Instrument for sleep evaluation | Kenzmedico Co., Ltd. | New device | Not listed | — | 349 days | A simple testing instrument for sleep apnea syndrome that records and analyzes respiratory waveforms during sleep. It can be used at home as well as in hospitals. It is placed on a mattress, detects subtle pressure changes in parts of the body surface associated with respiration, and expresses them as waveforms. It can measure pressure changes for up to 10 hours under unrestrained conditions. Because this product uses a novel method of detecting respiratory waveforms, it was compared in clinical studies with polysomnography (PSG), the standard test method for sleep apnea syndrome. |
| Jun 4, 2007 | Trident HA Acetabular Cup SystemHip prosthesis | Striker Japan K.K. | New device | Not listed | — | 809 days | A component system consisting of a shell, dome-hole plug, and ceramic liner used as a acetabular component in hip replacement. Beacuse of the novelty of the ceramic liner into which ceramic and metal layers are integrated and the special shell surface treatment employed, clinical studies were conducted to evaluate the efficacy and safety of this product in clinical use. |
| Jun 1, 2007 | QuickSiteImplantable pacemaker lead | St. Jude Medical CRMD | New device | Not listed | — | 914 days | OTW(Over-The-Wire) type of left ventricular lead used with implantable pulse generators such as CRT-D in CRT(Cardiac Resynchronization Therapy). (The original product is in a reexamination period) |
| Jun 1, 2007 | Epic HFOther defibrillator and related devices (implantable biventricular pacing pulse generator with defibrillator function) | St. Jude Medical CRMD | New device | Not listed | — | 914 days | Implantable pulse generator that delivers CRT, with function of defibrillator. (The original product is in a reexamination period) |
| Jun 1, 2007 | Atlas + HFOther defibrillator and related devices (implantable biventricular pacing pulse generator with defibrillator function) | St. Jude Medical CRMD | New device | Not listed | — | 914 days | Implantable pulse generator that delivers CRT, with function of defibrillator. (The original product is in a reexamination period) |
| Jun 1, 2007 | AesculaImplantable pacemaker lead | St. Jude Medical CRMD | New device | Not listed | — | 914 days | Left ventricular lead with stylet used with implantable pulse generators such as CRT-D in CRT(Cardiac Resynchronization Therapy). |
| May 30, 2007 | Proton Beam Therapy System PROBEAT (PT- W01)Other medical charged-particle radication therapy system (Proton beam therapy system) | Hitachi, Ltd. | New device | Not listed | — | 1098 days | A radiotherapy system using high-energy proton beam. It can shape the dose distribution of proton beam emitted from a synchrotron accelerator (beam energy, 80–200 MeV) to conform three-dimensionally to the size and shape of the affected site, and irradiate the site horizontally and vertically. (On application, the original product is in a reexamination period) |
| May 29, 2007 | Concerto C154DWKImplantable biventricular pacing pulse generator with defibrillator function | Medtronic Japan Co., Ltd | New device | Not listed | — | 279 days | Implantable pulse generator that delivers CRT, with function of defibrillator. (The original product is in a reexamination period) |
| May 22, 2007 | SEED UV-1Reusable colored contact lenses for correction of visual acuity | SEED Co., Ltd. | New device | Not listed | — | 475 days | Hard contact lenses that are made mainly of methacrylate monomers and that are indicated for daily or up to 1-week extended wear. These lenses have been specially designed to ensure sufficient oxygen permeability and strength. They use a new raw material constituted of a new combination of four already- approved monomers in a new ratio. Clinical studies were mainly conducted to evaluate the safety of these lenses in the eyes. |
| May 8, 2007 | CentPillar TMZF StemHip prosthesis | Striker Japan K.K. | New device | Not listed | — | 768 days | A cementless stem made of a titanium alloy for use as a femoral component in hip replacement. The proximal portion of the stem is subjected to surface roughening by plasma spraying of pure titanium followed by plasma coating with hydroxyapatite. Because of the novelty of the raw material and special surface treatment method employed, clinical studies were conducted to evaluate the efficacy and safety of this product in clinical use. |
| Apr 23, 2007 | Given Diagnostic Imaging SystemOther medical endoscope (capsule electronic endoscope system) | Given Imaging Ltd. | New device | Not listed | — | 1103 days | A small intestinal image recording system that consists mainly of a capsule-shaped image transmitter, a sensor array for receiving image data, an image data recorder, and a RAPID workstation for reviewing recorded image data. This is the first medical device in Japan to provide diagnostic images of the small intestinal mucosa through a capsule swallowed by the patient. |
Dexcom, Inc.
Rapid Medical Ltd.
Canon Medical Systems Corporation
Abiomed, Inc.
FUJIFILM Corporation
ORTHOREBIRTH Co., Ltd.
Nidek Co., Ltd.
Nobelpharma Co., Ltd.
GC Corporation
Atom Medical Corporation
Shimadzu Corporation
Tornier S.A.S.
Olympus Medical Systems CorporationThe US approval date and FDA number are as PMDA lists them; PMDA started listing them in later tables, and gives none for many devices. The 2004 to 2006 tables use another layout and are left out, as are about 2% of rows the PDF does not split cleanly. Review time is PMDA's total, including time the applicant spent answering questions. Refreshed weekly. PMDA, List of Approved Medical Devices (English)