Edwards Lifesciences Comments on FDA Warning Letter

Edwards Lifesciences Comments on FDA Warning Letter 
IRVINE, CA -- (Marketwired) -- 05/29/13 --  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. 
Edwards, Edwards Lifesciences and the stylized E logo are trademarks
of Edwards Lifesciences Corporation. 
Media Contact:
Sarah Huoh
949-250-5070 
Investor Contact:
Kim Welsh
949-250-3828 
 
 
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