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Edwards Receives CE Mark For Two New Cardiac Valve, Delivery Systems

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

Edwards Lifesciences said that it would introduce the systems commercially in Europe during the second quarter. The Ascendra 2 system features a reduced profile and is designed for improving ease-of-use when delivering the valve through a small incision between the ribs.

The Edwards Sapien XT transcatheter valve enables doctors to replace failing aortic valves without major surgery. The leaflet design of the new valve is modeled after Edwards’ clinically proven aortic tissue valves and its cobalt chromium frame provides improved radial strength and, therefore, enhanced circularity.

The Edwards Sapien XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-expandable delivery of the valve.

It is the commercially available transcatheter valve in the Edwards Sapien product portfolio. In the US, the Edwards Sapien valve is an investigational device being studied as part of the randomized, pivotal clinical trial of a transcatheter aortic valve and not yet available commercially.

Larry Wood, corporate vice president of transcatheter valve replacement at Edwards, said: “The Edwards Sapien XT valve platform offers best-in-class valve performance with a low-profile delivery system. We are excited about the new platform and our continued leadership in this transformational technology.”