SOURCE: Edwards Lifesciences

October 13, 2008 12:00 ET

Edwards Lifesciences' New Transcatheter Heart Valve Data Demonstrate Positive Results

WASHINGTON, DC--(Marketwire - October 13, 2008) - Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that new data from two studies of the Edwards SAPIEN transcatheter aortic heart valve with the RetroFlex transfemoral delivery system were presented today at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The 30-day results from the European post-CE Mark SOURCE registry of 303 transfemoral patients demonstrated a survival rate of 94 percent. SOURCE is designed to evaluate the use of the Edwards SAPIEN valve in a hospital's first 10 commercial cases, following Edwards' prescribed training program. The majority of the SOURCE cases at 34 independent cardiac intervention centers were not proctored.

The second study, PARTNER EU, is an observational multi-center study conducted in Europe from April 2007 through January 2008 that enrolled 54 transfemoral patients. Interim follow-up results demonstrated a 92 percent survival rate at 30 days and 90 percent survival at six months. Had these very ill patients been treated with traditional open-heart surgery, the 30-day predicted survival would have been 75 percent.

"The data from the European commercial launch of the Edwards SAPIEN transcatheter valve with the transfemoral delivery system have exceeded our expectations," said Michael A. Mussallem, Edwards' chairman and CEO. "Considering the high-risk characteristics of this patient population and the demonstrated outcomes, we believe transcatheter valve replacement is a viable treatment option. We are proud of the results, which can be attributed to the valve technology, our comprehensive training program and the dedication of the physicians involved in the studies."

Separately, in the United States, Edwards is the only company to currently have underway a pivotal clinical trial of a transcatheter aortic valve replacement. This multi-center study includes both transfemoral (from the leg) and transapical (between the ribs) delivery systems for the transcatheter valve replacement. Edwards is also the only company to have both delivery system approaches for this procedure; valve delivery with either approach is performed while the heart continues to beat and without open-heart surgery or cardiopulmonary bypass.

The Edwards SAPIEN transcatheter heart valve is approved for commercial sale in Europe. In the United States, it is an investigational device that is not available for sale.

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

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 timing and progress of clinical studies relating to the company's transcatheter valve technologies. 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 and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. CardioVations is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.

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