Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter H...( IRVINE Calif. Sept. 5 /- Edwards ...),Health

IRVINE, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today 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. It is the first transcatheter bovine pericardial valve incorporating technological advancements and design elements that allow for greater ease of implantation by physicians. 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.

"This is a landmark achievement for this transformational technology, which holds promise for the large number of high-risk patients suffering from severe aortic stenosis," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "As the global leader in heart valve therapy, we are committed to working closely with our European clinical partners on this transcatheter technology, in order to provide optimal clinical outcomes for the many high-risk patients in need of aortic valve replacements, who might otherwise have limited or no treatment options."

"In this pioneering procedure, the skill sets of the surgeon and the interventional cardiologist complement each other to provide for better patient care," said Martin B. Leon, MD, Professor of Medicine and Associate Director of the Center for Interventional Vascular Therap
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