IRVINE, Calif., May 30 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , a world leader in products and technologies to treat advanced cardiovascular disease, said today that it has received additional questions from the U.S. Food and Drug Administration (FDA) regarding the company's submission for premarket approval of LifeStent products for a superficial femoral artery (SFA) indication. These questions pertain to preclinical bench testing and the clarification of open items already under review by the FDA. Edwards expects to respond promptly to the FDA and continues to anticipate receiving an SFA indication by the end of the year. Earlier this year, Edwards completed the sale of the LifeStent product line to C.R. Bard, Inc.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company'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 at http://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 promptly respond to the FDA's questions and receive an SFA indication by the end of the year. 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.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements 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, 2007.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
CONTACT: Media, Amanda Fowler, +1-949-250-5070, or Investors, David K.
Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
Web site: http://www.edwards.com/
