Edwards Sapien XT valve, delivery systems receive CE mark

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Edwards Lifesciences has received CE mark for its Edwards Sapien XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems.

The Irvine, Calif.-based company is beginning a launch of the new valve and the 18 French NovaFlex delivery system in certain parts of the Europe, expanding the number of sites utilizing the system throughout the year. The Ascendra 2 system will roll out during the second quarter of 2010.

The Sapien XT transcatheter valve enables interventional cardiologists to replace failing aortic valves without major surgery. According to the company, the leaflet design and cobalt chromium frame provide improved radial strength.

The NovaFlex transfemoral delivery system is designed to provide balloon-expandable delivery of the valve. The Ascendra 2 system features a reduced profile and is designed for delivering the valve through a small incision between the ribs, according to the company.

The Sapien valve is not commercially available in the U.S.