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Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve
Date:4/18/2008

replacement procedure, the Edwards SAPIEN bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.

"Edwards is proud to have the opportunity to address this critical unmet patient need and to offer these patients a far less traumatic treatment option," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "This therapy leverages all of our Edwards SAPIEN valve platform technologies to help these congenital patients via a minimally-invasive treatment alternative." Edwards' physician partners performed the first U.S. transcatheter pulmonic case on a compassionate basis in December 2005. All of the compassionate cases have been successful.

The Edwards SAPIEN transcatheter heart valve is also currently being studied in the PARTNER (Placement of AoRTic traNscathetER valves) U.S. pivotal trial for the treatment of patients with severe aortic heart valve stenosis (a narrowing of the aortic valve that restricts blood flow), who are considered to be high risk for conventional open-heart valve replacement surgery.

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 S
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SOURCE Edwards Lifesciences Corporation
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