Edwards Lifesciences Comments on FDA Warning Letter

IRVINE, CA, Apr 06 (MARKET WIRE) --
Edwards Lifesciences Corporation (NYSE: EW) announced today that it has
received a warning letter from the U.S. Food and Drug Administration
(FDA) resulting from an inspection of Edwards' facility in Irvine,
Calif., conducted in September 2009. The letter contains one observation
related to six incidences of late MDR reporting that ranged from six to
29 days beyond the 30-day reporting requirement. The company's training
procedures on the MDR reporting process were corrected during the
inspection and discussed with the FDA. The FDA subsequently issued its
Establishment Inspection Report (EIR) in October 2009 concluding its
inspection.

Edwards does not expect this matter to have any impact on product
approvals.

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.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards
Lifesciences and the stylized E logo are trademarks of Edwards
Lifesciences Corporation and are registered in the United States Patent
and Trademark Office.

Media Contact:
Sarah Huoh, 949-250-5070

Investor Contact:
David K. Erickson, 949-250-6826

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