An FDA advisory panel will review the premarket approval (PMA) application for the Sapien transcatheter aortic valve on July 20, the device’s manufacturer, Edwards, has announced. The application is based on results from the PARTNER B trial, which compared the Sapien valve to optimal medical therapy in patients with severe aortic stenosis who were not eligible for surgery.
Here is the Edwards press release:
FDA Advisory Panel to Review Edwards SAPIEN Valve on July 20
IRVINE, CA, June 07, 2011 — 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 is scheduled to review the company’s Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on July 20, 2011. Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort (Cohort B) of The PARTNER Trial, for approval of this therapy in the treatment of inoperable patients with severe aortic stenosis.
The inoperable cohort compared outcomes after treatment with either standard therapy or the Edwards SAPIEN valve in 358 patients. The results of this study were published in The New England Journal of Medicine in September 2010.
The Edwards SAPIEN heart valve is an investigational device in the U.S. and not yet available commercially in the U.S.
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 http://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 data from The PARTNER Trial for transcatheter valve products. 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
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