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FDA panel recommends approval of Edwards transcatheter heart valve for certain inoperable patients.

Edwards Lifesciences Corporation, Gaithersburg, MD, announced a FDA Advisory Panel has voted to recommend approval of the company's Sapien transcatheter heart valve for the treatment of certain inoperable patients. Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort of The Partner Trial. The cohort compared the outcomes of 358 patients after treatment with either standard therapy or the Edwards Sapien valve delivered transfemorally.

If the valve gains approval, the Edwards device would be the first co-called transcatheter valve sold in a US market estimated to reach $1.3 billion by 2014, according to a report from Bloomberg Industries. The valve has been available in Europe since 2007.

About 300,000 people in the US suffer from aortic stenosis, according to Edwards. Two-thirds undergo standard chest-cracking surgery to replace the valve, while the risk of surgery may be too high for the rest.

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Publication:Transplant News
Date:Aug 1, 2011
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