Edwards Sapien XT Valve and Delivery Systems Receive CE Mark

March 2, 2010—Edwards Lifesciences (Irvine, CA) announced that it has received CE Mark approval for the Edwards Sapien XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems. The company is beginning a limited European launch of the new valve and the 18-F NovaFlex delivery system in the second quarter of 2010.

According to the company, the Sapien XT valve's leaflet design is modeled after their clinically proven aortic tissue valves. Its cobalt-chromium frame provides improved radial strength for enhanced circularity. The Sapien XT is the second commercially available transcatheter valve in the Edwards Sapien product portfolio. In the United States, the Edwards Sapien valve is an investigational device being studied in a randomized, pivotal clinical trial.