Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that it has begun enrolling patients in Japan's first clinical trial studying transcatheter aortic heart valves. Utilizing the recently CE Marked-Edwards SAPIEN XT valve, this study adds another first to Edwards' series of landmark transcatheter heart valve trials and extends the company's global leadership in transcatheter valve technology.

Three of Japan's leading cardiovascular centers are participating in the PREVAIL JAPAN trial, including Osaka University Hospital (Osaka), Sakakibara Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama). The trial is studying the treatment of Japanese patients suffering from severe aortic stenosis with a valve that can be implanted in a beating heart with a catheter, eliminating the need for major surgery.

"Our comprehensive transcatheter valve program is built on scientifically rigorous studies, specialized training for multi-disciplinary heart teams and purposeful innovation that addresses the unmet needs of clinicians and patients worldwide," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "The features of the Edwards SAPIEN XT valve make it well-suited for Japanese patients seeking less-invasive medical solutions. We anticipate that successful trial completion could result in product approval in Japan as early as 2013."

The new Edwards SAPIEN XT valve is low profile, yet designed to maintain radial strength through its cobalt chromium balloon-expandable frame. This design is intended to enhance circularity and restore proper hemodynamics, or blood flow, for the patient. The valve's bovine pericardial tissue leaflets are based on Edwards' clinically proven surgical heart valves.

Two delivery methods for the Edwards SAPIEN XT valve will be evaluated in the trial -- the NovaFlex transfemoral and the Ascendra 2 transapical systems -- which are designed to make valve delivery and deployment easier for clinicians.

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Edwards Lifesciences