2/14/2013

The Society of Thoracic Surgeons and the American College of Cardiology recently have received investigational device exemption approval from the FDA to conduct a clinical study evaluating the use of Edwards Lifesciences' Sapien device in patients who are deemed not eligible for aortic valve surgery. The groups are now pursuing FDA approval for two more studies in hopes of expanding the uses of transcatheter aortic valve replacement.

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Forbes

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