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FDA Warns Edwards Lifesciences (EW) on Quality


5/30/2013 8:02:31 AM

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Edwards Lifesciences Comments on FDA Warning Letter

IRVINE, CA--Edwards Lifesciences Corporation (NYSE: EW) announced today that it has received a warning letter from the Denver District Office of the U.S. Food and Drug Administration (FDA) resulting from an inspection of Edwards' facility in Draper, Utah, that concluded in Feb. 2013. The FDA warning relates specifically to the execution of the company's quality systems within the Cardiac Surgery Systems (CSS) business, including design and process validation, corrective and preventive actions, finished device acceptance and packaging. The company does not expect this matter to have a material impact on its 2013 financial guidance.

Edwards' Utah facility manufactures devices for CSS, such as cannulae and cardioplegia catheters, and also makes devices for other Edwards businesses, including heart valve repair rings and transcatheter heart valve delivery system components and accessories.

"We are committed to thoroughly addressing the issues identified with the quality systems for our CSS devices, and have already initiated responses to address FDA's observations," said Michael A. Mussallem, Edwards' chairman and CEO. "Our first priority is delivering quality, life-saving devices to patients."

The letter states that, until Edwards resolves the issues in the warning letter, it will not receive premarket approvals for devices reasonably related to those issues.

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, enabling 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, the company's ability to achieve 2013 financial goals. 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 results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated delays in addressing the issues identified in the letter or unexpected ramifications of the warning letter. 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, 2012.



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