CoreValve gets CE mark
This article was originally published in The Gray Sheet
Executive Summary
Firm will not immediately launch its ReValving percutaneous aortic valve following European clearance announced May 16 for high-risk patients. Instead, an expanded clinical evaluation at selected centers will focus on physician training, appropriate patient selection and gathering clinical feedback, the firm says. It expects data from a mandatory patient registry to help support FDA go-ahead to start a clinical trial for the device in the United States. Competitor Edwards Lifesciences, which received FDA approval for a U.S. trial in March, expects CE mark later this year for its Sapien transcatheter aortic valve. The firm recently filed a patent suit against CoreValve in Germany (1"The Gray Sheet" May 14, 2007, In Brief)...
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