Edwards Lifesciences Comments on FDA Warning Letter

IRVINE, CA--(Marketwire - April 06, 2010) - 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.