Reuters: Regulatory News: US advisers back Edwards valve for wider group

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US advisers back Edwards valve for wider group Jun 13th 2012, 22:08 GAITHERSBURG, Md., June 13 | Wed Jun 13, 2012 6:08pm EDT GAITHERSBURG, Md., June 13 (Reuters) - An artificial heart valve from Edwards Lifesciences Corp that can be inserted without cracking open the chest for surgery won the support of U.S. advisers on Wednesday for use in a wider group of patients. A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Sapien device outweigh its risks for people who need a new heart valve but face a higher risk of dying from open-heart surgery. The valve is Edwards' most important new product, and was already approved last year for those deemed too sick to have the open-heart surgery. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.

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