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"Edwards is proud to extend our leadership in this transformationaltechnology with this important development in our transcatheter heart valveprogram," said Larry L. Wood, Edwards' corporate vice president, transcathetervalve replacement. "We expect to initiate a clinical trial of this new valvein Europe before the end of the year."
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Edwards' next-generation balloon-expandable pericardial tissue valvefeatures a cobalt chromium alloy frame that reduces the profile by four tofive French. This enables easier access into and within the patient'svasculature for delivery of the valve without open-heart surgery. The newvalve will also be offered in additional sizes and builds upon Edwards' morethan 20 years of clinical experience and innovation with the most advancedtissue engineering technologies.
"This is a very exciting milestone in the progression ofminimally-invasive valve therapy. The refinements to the new Edwards valveprovide the opportunity to make the transcatheter technology available to aneven broader group of patients suffering from severe aortic stenosis," saidWebb, who along with his multidisciplinary team has performed more than 150transcatheter aortic valve replacement procedures. "Providing patients andclinicians with a comprehensive selection of treatment options, including thisnew valve, can increase the likelihood that these very ill patients will seekand find appropriate treatment."
Edwards is the only company currently engaged in a U.S. clinical trial ofa transcatheter aortic heart valve. The Edwards SAPIEN valve with both theRetroFlex transfemoral and Ascendra transapical delivery systems is beingevaluated in the PARTNER (Placement of AoRTic traNscathetER valves) pivotaltrial for U.S. Food and Drug Administration (FDA) approval.
"We estimate that for every patient who receives an aortic valvereplacement, there is another who goes untreated; half of these untreatedpatients with severe symptoms will die within two years," said Craig Smith,M.D., chief of the division of cardiothoracic surgery at New York-PresbyterianHospital/Columbia University Medical Center and the co-principal investigatorfor the U.S. PARTNER trial. "Soon physicians will be able to treat virtuallyall high-risk aortic stenosis patients with transcatheter valves, deliveredtransapically or transfemorally, as we continue to carefully study thelong-term performance of this technology."
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 celebrates50 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 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 timing and progress of clinical studies relating to thecompany's transcatheter valve technologies and the market opportunity fortranscatheter technologies. Forward-looking statements are based on estimat
