IRVINE, Calif., May 30 Edwards LifesciencesCorporation (NYSE: EW), a world leader in products and technologies to treatadvanced cardiovascular disease, said today that it has received additionalquestions from the U.S. Food and Drug Administration (FDA) regarding thecompany's submission for premarket approval of LifeStent products for asuperficial femoral artery (SFA) indication. These questions pertain topreclinical bench testing and the clarification of open items already underreview by the FDA. Edwards expects to respond promptly to the FDA andcontinues to anticipate receiving an SFA indication by the end of the year.Earlier this year, Edwards completed the sale of the LifeStent product line toC.R. Bard, Inc.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valvesand hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treatsadvanced cardiovascular disease with its market-leading heart valve therapies,and critical care and vascular technologies. In 2008, Edwards celebrates 50years of partnering with clinicians to develop life-saving innovations. Thecompany's global brands, which are sold in approximately 100 countries,include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty,PERIMOUNT Magna and Swan-Ganz. Additional company information can be found athttp://www.edwards.com.
This news release includes forward-looking statements within the meaningof Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. These forward-looking statements include, but are notlimited to, the company's ability to promptly respond to the FDA's questionsand receive an SFA indication by the end of the year. Forward-lookingstatements are based on estimates and assumptions made by management of thecompany and are believed to be reasonable, though they are inherentlyuncertain and difficult to predict.
Forward-looking statements involve risks and uncertainties that couldcause actual results or experience to differ materially from that expressed orimplied by the forward-looking statements. Factors that could cause actualresults or experience to differ materially from that expressed or implied bythe forward-looking statements are detailed in the company's filings with theSecurities and Exchange Commission including its Annual Report on Form 10-Kfor the year ended December 31, 2007.
Edwards is a trademark of Edwards Lifesciences Corporation. EdwardsLifesciences, the stylized E logo, CardioVations, Carpentier-Edwards,Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, and Swan-Ganz aretrademarks of Edwards Lifesciences Corporation and are registered in theUnited States Patent and Trademark Office.
SOURCE Edwards Lifesciences Corporation