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Edwards Lifesciences transcatheter heart valve gains European market go-ahead

This article was originally published in The Gray Sheet

Executive Summary

Edwards will launch its Sapien transcatheter aortic heart valve in Europe in the fourth quarter following CE mark clearance, announced Sept. 5. The device is indicated for patients at high risk for open surgery. While the initial clearance covers use of Sapien with the firm's RetroFlex transfemoral delivery system, Edwards expects expanded approval by year end for use with its Ascendra transapicaldelivery system. The approval reportedly sets the stage for projected Sapien sales of over $20 million in 2008. A U.S. trial also is underway (1"The Gray Sheet" March 26, 2007, p. 10). Competitor CoreValve gained European approval of its ReValving percutaneous aortic valve in May, but has not yet fully commercialized the product (2"The Gray Sheet" May 21, 2007, In Brief). CoreValve also has a transapical system in development...

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Edwards vs. CoreValve

Edwards Lifesciences files patent suit Feb. 12 against CoreValve in Delaware District court alleging CoreValve's ReValving percutaneous aortic valve replacement system infringes three Edwards' patents related to transcatheter heart valves. Edwards has filed similar litigation in Germany and the U.K. The latest suit is directed at CoreValve devices made in the United States and sold in Europe, where ReValving earned a CE mark in May 2007. Edwards recently launched its Sapien transcatheter aortic replacement heart valve in Europe and has begun the PARTNER pivotal trial of the device in the United States (1"The Gray Sheet" Sept. 10, 2007, In Brief)

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Edwards Lifesciences is facing enrollment delays in its U.S. pivotal trial of a less invasive heart valve, though the company still says it will complete the patient sign-up effort by the end of next year

Edwards Set To Launch “Two-Trials-In-One” For Sapien Percutaneous Valve

Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says




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