GAITHERSBURG, MD, Jul 20, 2011 -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced that a U.S. Food and Drug Administration (FDA) Advisory Panel voted late today to recommend approval of the Edwards SAPIEN transcatheter heart valve for the treatment of certain inoperable patients.
Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort of The PARTNER Trial. This cohort compared the outcomes of 358 patients after treatment with either standard therapy or the Edwards SAPIEN valve delivered transfemorally.
“We are pleased with the panel’s strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN,” said Michael A. Mussallem, Edwards’ chairman and CEO. “We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy.”
The Edwards SAPIEN valve is an investigational device in the U.S. and not yet available commercially in the U.S. It received CE Mark approval for European commercial sale in late 2007.
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, Mr. Mussallem’s statements regarding the potential FDA approval 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. 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
SOURCE: Edwards Lifesciences
