FDA approves SAPIEN 3 Transcatheter Heart Valve to treat aortic stenosis- Edwards Lifesciences

Edwards Lifesciences Corporation announced FDA approval of its most advanced transcatheter aortic heart valve � the Edwards SAPIEN 3 valve with the Commander Delivery System � for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.

The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves. The new valve, available in 20mm, 23mm, 26mm and 29mm sizes, has an outer skirt � a cuff of fabric surrounding the valve frame � providing a seal to address paravalvular leak.

Comment:"The SAPIEN 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes," said Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons. "We have seen some of the best results to date from the PARTNER II Trial in treating high-risk patients with the SAPIEN 3 valve. The PARTNER II study concluded that this new valve reduced several complications associated with the TAVR procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices" .