Edwards Lifesciences (NYSE:EW) said it won an investigational device exemption from the FDA to run a clinical trial of its Sapien 3 replacement heart valve in intermediate-risk patients.
Replacement Heart Valves
TAVI: Direct Flow lands EU win, closes U.S. study of aortic valve
California medtech company Direct Flow Medical notched some major milestones today, announcing a European regulatory win and completed enrollment in a U.S. feasibility trial for its transcatheter aortic valve implantation systems.
St. Jude Medical wins CE Mark for larger Portico heart valve
St. Jude Medical (NYSE:STJ) said it won CE Mark approval in the European Union for the 25mm version of its Portico replacement heart valve.
Edwards Lifesciences’ Sapien forecast misses expectations
A conservative forecast for 2014 sent shares of Edwards Lifesciences (NYSE:EW) down more than 5% yesterday and kept them flat today, as the medical device company said it expects more competition next year for its flagship Sapien replacement heart valve.
TAVI: Claret Medical asks FDA to approve Sentinel trial
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.
TAVI: Transcatheter Tech. touts 30-day results of ‘truly repositionable’ valve
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 scores CE Mark for sutureless heart 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 wins CE Mark for stentless heart 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.
Medicare considers coverage for Abbott’s MitraClip mitral valve repair system
Replacement heart valves: Real-world results for Sapien equivalent to trial results
Boston Scientific’s TAVI system hits the German market
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.