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Edwards Lifesciences Receives FDA Approval to Add Transapical Delivery System to U.S. Clinical Trial of Transcatheter Heart Valve
Date:1/29/2008

nt, but face excessive risk with alternative approaches," said Craig 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.

The surgical arm of the trial evaluates the Edwards SAPIEN valve and the two transcatheter delivery systems -- Ascendra for transapical access, and RetroFlex for transfemoral access -- as compared to surgical, open-heart valve replacement. The medical management arm of the trial evaluates the Edwards SAPIEN valve with the RetroFlex transfemoral delivery system as compared to appropriate medical therapy.

Edwards has significant experience with transcatheter valve procedures based on more than 600 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the U.S. and Canada. The Edwards SAPIEN valve with the Ascendra transapical and RetroFlex transfemoral delivery systems is commercially available in Europe.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include 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 compa
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SOURCE Edwards Lifesciences
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