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Clinical and Economic Data From The PARTNER Trial to Be Presented at ACC 2011


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Published in Health and Fitness on by Market Wire   Print publication without navigation


IRVINE, CA--(Marketwire - March 28, 2011) - Edwards Lifesciences Corporation (NYSE: [ EW ]), the global leader in the science of heart valves and hemodynamic monitoring, today announced that one-year clinical outcomes from Cohort A of The PARTNER Trial are scheduled to be presented at 9:15 a.m. CT on Sunday, April 3, at the American College of Cardiology's (ACC) 60th Annual Scientific Session & Expo in New Orleans, La. Additionally, economic data from Cohort B of The PARTNER Trial will be featured in a session scheduled immediately after, at 9:45 a.m. CT.

The PARTNER Trial is the world's first randomized clinical trial of a transcatheter aortic heart valve and is studying the Edwards SAPIEN valve in both operable (Cohort A) and inoperable (Cohort B) patients with severe aortic stenosis. Cohort A compares outcomes after treatment with either the Edwards SAPIEN valve or traditional open-heart surgery in 699 high-risk, operable patients. The study is a "non-inferiority" trial designed to evaluate whether patient outcomes after transcatheter aortic valve replacement with the Edwards SAPIEN valve are comparable to surgical outcomes in these patients.

Cohort B compared outcomes after treatment with either medical management or the Edwards SAPIEN valve in 358 inoperable patients. In September 2010, The New England Journal of Medicine published data on Cohort B, showing it successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization.

The Edwards SAPIEN heart valve is an investigational device in the U.S. and not yet available commercially in this country.

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 presentation of clinical and economic 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 conference 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 and PARTNER are trademarks of Edwards Lifesciences Corporation.


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