SOURCE: Edwards Lifesciences

Edwards Lifesciences

April 26, 2010 09:00 ET

First Transcatheter Valve Clinical Trial in Japan Treats Patients With Edwards SAPIEN XT Valve

IRVINE, CA--(Marketwire - April 26, 2010) -  Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today 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.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," or other similar expressions and include, but are not limited to, the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter technologies. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2009.

Edwards, Ascendra 2, NovaFlex and Edwards SAPIEN XT are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

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