FDA Panel Recommends Approval of Edwards Transcatheter Valve for High-Risk Patients
GAITHERSBURG, MD -- (Marketwire) -- 06/13/12 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that a U.S. Food and Drug Administration (FDA) Advisory Panel voted in favor of recommending approval of the Edwards SAPIEN transcatheter heart valve via transfemoral and transapical delivery for the treatment of high-risk patients with severe, symptomatic aortic stenosis. The panel voted 11 to 0, with one abstention, that the benefits of the heart valve outweighed the risks for these patients.
Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery evenly randomized to receive either surgical aortic valve replacement or the Edwards SAPIEN valve via transfemoral or transapical delivery. In November 2011, the FDA approved SAPIEN via transfemoral delivery for the treatment of inoperable patients with severe, symptomatic aortic stenosis.
"We are very encouraged by the Advisory Panel's strong recommendation for approval to expand the current indication for the Edwards SAPIEN valve to patients at high risk for surgery. A broader indication for high-risk patients would enable multi-disciplinary Heart Teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option," said Michael A. Mussallem, Edwards' chairman and CEO. "We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis of The PARTNER Trial results."
The Edwards SAPIEN valve is currently an investigational device for the treatment of high-risk operable patients in the U.S.
About Edwards Lifesciences (EW)
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 www.edwards.com.
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 include, but are not limited to, Mr. Mussallem's statements, and the potential for FDA approval of the expanded indication for, and benefits of, the Edwards SAPIEN valve. 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 those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected delays in, or changes to the outcome of, the U.S. FDA regulatory approval process or schedule, and unexpected outcomes from expanded clinical and commercial experience with the device. These factors 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, 2011.
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Source: Edwards Lifesciences