Category: Replacement Heart Valves
Claret Medical says it's asked the FDA for an investigational device exemption for a clinical trial of its Sentinel device, designed to prevent embolisms during transcatheter aortic valve implantation.
Claret Medical said it filed asked for an investigative device exemption from the FDA for a clinical trial of its Sentinel cerebral protection system.
Santa Rosa, Calif.-based Claret wants to conduct a multicenter study using the Sentinel for embolic protection during transcatheter aortic valve implantation, comparing use of the Sentinel device with standard care.
German device maker Transcatheter Technologies reports positive early findings from a study of its "game-changer" Trinity transcatheter aortic valve implantation system.
Emerging medical device maker Transcatheter Technologies GmbH unveiled an early look at clinical results for its 3rd-generation Trinity transcatheter aortic valve implantation platform, which the company calls "the world's 1st 'truly repositionable' and, therefore, best TAVI system."
Sorin Group says it won CE Mark approval in the European Union for the XL version of its Perceval aortic valve.
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for the XL version of its Perceval sutureless aortic valve.
Milan-based Sorin said the new approval is for treating patients with annulus sizes ranging from 19 mm to 27 mm using the Perceval device.
Sorin Group says it won CE Mark approval in the European Union for its Solo Smart stentless aortic valve.
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for its Solo Smart heart valve, designed to replace the aortic valve without leaving a stent in place.
A coalition of physicians' groups petition the Centers for Medicare & Medicaid to issue a coverage decision for transcatheter mitral valve implantation systems such as Abbott Labs' recently approved MitraClip.
The Sapien replacement heart valve fares as well in the real world as it did during clinical trials, according to an analysis in the Journal of the American Medical Assn.
Boston Scientific's Lotus transcatheter aortic valve implantation system hits the market in Germany, where TAVI titans and medtech rivals Medtronic and Edwards Lifesciences have been battling for control.
Boston Scientific (NYSE:BSX) has officially hit the German market with the 1st commercial patients treated this month, just weeks after the company won CE Mark approval to sell the product in the European Union.