Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor ...
Tags: XT Valve, Edwards Lifesciences
Sorin, a medical device firm, has entered into deal to manufacture certain components of Boston Scientific's Lotus Aortic Valve System. Lotus Aortic Valve System is Boston Scientific's second-generation transcatheter aortic valve ...
Tags: Aortic Valve System, Sorin Inks
Helio System (TF-FA), an investigational equipment developed for use with the Sapien XT Transcatheter Heart Valve, has been deployed successfully in four patients during a feasibility trial of its use in patients with high-risk aortic ...
Tags: Aortic Insufficiency, Medicine
Direct Flow Medical, a developer of novel transcatheter heart valve technologies, has met its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30 days. The trial had enrolled 100 patients ...
Tags: Aortic Valve, Medicine
CircuLite has received an approval from the Federal Agency for Medicines and Health Products to begin the CE Mark trial of the Synergy IC Circulatory Support System (SICSS), which is designed for interventional cardiologist cannula ...
Tags: Circulite, CE Mark Trial
Sorin Group has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a clinical study of its PERCEVAL S sutureless aortic tissue valve. The bioprosthetic valve is designed ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Vital Images' CT transcatheter aortic valve replacement (TAVR) planning application. TAVR procedures, in general, use endovascular techniques to replace faulty ...
Medtronic has gained CE mark approval for its Engager transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, from the European Union (EU). The new TAVI system, which is inserted in the apex (the lower, ...
Tags: Medtronic, transcatheter aortic valve implantation, TAVI
The US Patent & Trademark Office (USPTO) has granted a patent to US-based Colibri Heart Valve for a pre-packaged, sterilized, dry heart valve pre-mounted on a delivery system. The Patent No 8,361,144, which is entitled as 'Percutaneously ...
Tags: dry heart valve, Colibri, delivery system
St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery. The 23 mm ...
Tags: CE mark, aortic heart valve, medical device, Medical equipment
The US Food and Drug Administration (FDA) has cleared Loma Vista Medical's TRUE Dilatation Balloon Valvuloplasty catheter, designed to prevent balloon ruptures in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve ...
Tags: FDA, Loma Vista, Balloon Valvuloplasty catheter, BAV
Boston Scientific has completed enrolling first patient in REPRISE II clinical trial, designed to assess the safety and efficacy of the Lotus Valve system in minimizing aortic regurgitation (leaking). The Lotus Valve system, which the ...
Tags: Boston Scientific, first patient, REPRISE II clinical trial
Sorin Group has announced the US launch of a Mitroflow Valsalva Conduit graft, designed for use in combination with a Mitroflow pericardial aortic valve. The Conduit graft enables surgeons to replace simultaneously the ascending aorta and ...
Tags: Sorin, launch, Conduit graft, combination, Mitroflow graft
Medtronic has treated the first US patient in a global, multicenter clinical trial, designed to compare the accuracy of its CoreValve system with surgical aortic valve replacement in treating patients with severe aortic stenosis and who are ...
Edwards Lifesciences is set to begin clinical trial to assess its Intuity valve system, following an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). The prospective, multi-center study, ...
Tags: clinical trial, Intuity valve system, FDA