Three Implants of New Transcatheter Heart Valve Completed


March 5, 2008

March 5, 2008 - Edwards Lifesciences Corp. reported that the first three human implants of the next-generation Edwards transcatheter aortic heart valve were performed at St. Paul's Hospital in Vancouver, British Columbia, marking the progression of minimally-invasive valve therapy.
Edwards’ next-generation balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This is designed to enable 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. The company expects to initiate a clinical trial of this new valve in Europe before the end of the year.
"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 John Webb, M.D., director of the cath lab and cardiac intervention at St. Paul's Hospital in Vancouver, British Columbia, who along with his multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures.
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 FDA approval.

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