IRVINE, Calif., March 5, 2008 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced the first three human implants of the next-generation Edwards transcatheter aortic heart valve, performed byJohn Webb, M.D., director of the cath lab and cardiac intervention at St. Paul's Hospital in Vancouver, British Columbia.
"Edwards is proud to extend our leadership in this transformational technology with this important development in our transcatheter heart valve program," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "We expect to initiate a clinical trial of this new valve in Europe before the end of the year."
Edwards' next-generation balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient's vasculature for delivery of the valve without open-heart surgery. The new valve will also be offered in additional sizes and builds upon Edwards' more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies.
"This is a very exciting milestone in the progression of minimally-invasive valve therapy. The refinements to the new Edwards valve provide the opportunity to make the transcatheter technology available to an even broader group of patients suffering from severe aortic stenosis," said Webb, who along with his multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures. "Providing patients and clinicians with a comprehensive selection of treatment options, including this new valve, can increase the likelihood that these very ill patients will seek and find appropriate treatment."
Edwards is the only company currently engaged in a U.S. clinical trial of a transcatheter aortic heart valve. The Edwards SAPIEN valve with both the RetroFlex transfemoral and Ascendra transapical delivery systems is being evaluated in the PARTNER (Placement of AoRTic traNscathetER valves) pivotal trial for U.S. Food and Drug Administration (FDA) approval.
"We estimate that for every patient who receives an aortic valve replacement, there is another who goes untreated; half of these untreated patients with severe symptoms will die within two years," saidCraig Smith, M.D., chief of the division of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial. "Soon physicians will be able to treat virtually all high-risk aortic stenosis patients with transcatheter valves, delivered transapically or transfemorally, as we continue to carefully study the long-term performance of this technology."
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 timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter 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, Edwards SAPIEN and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, 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.