IRVINE, CA--(Marketwire - April 09, 2012) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel has proposed a review of the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on June 13, 2012. Edwards submitted a PMA application in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial, for approval of this therapy in the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery.
The high-risk cohort compared outcomes after treatment of 699 patients with either surgical valve replacement or the Edwards SAPIEN valve via transfemoral or transapical delivery. The one-year results of this study were presented in April 2011 at the American College of Cardiology's (ACC) Annual Scientific Sessions and published in The New England Journal of Medicine in June 2011.
The Edwards SAPIEN transcatheter heart valve received FDA approval for the treatment of certain inoperable patients in November 2011. It is currently an investigational device for the treatment of high-risk patients in the U.S. and is awaiting approval.
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 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, statements regarding the FDA Advisory Panel's plans to review the company's PMA application for the Edwards SAPIEN valve for patients at high risk for surgery. 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 or changes in the meeting schedule. 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.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.