CE Mark Approves Transcatheter Heart Valve
September 5, 2007 - Edwards Lifesciences Corp. announced that it has received CE Mark approval for European commercial sales of its Edwards SAPIEN transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system.
The Edwards SAPIEN transcatheter heart valve is implanted via a minimally-invasive procedure, without requiring open-heart surgery. The valve is designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow), who are considered to be high-risk or non-operable for conventional open-heart valve replacement surgery.
The Edwards SAPIEN transcatheter heart valve integrates balloon-expandable stent technology that leverages the company’s proprietary bovine pericardial tissue. With the RetroFlex transfemoral delivery system, the Edwards SAPIEN valve is compressed onto the balloon to the approximate diameter of a pencil and threaded through the patient’s circulatory system from the leg and expanded into place directly over the diseased aortic valve.
For more information: www.edwards.com
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