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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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