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FDA Approval of New Valve Indications May Save Edwards Sales Projections

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Edwards Lifesciences garnered FDA approval of an expanded indication for the Sapien heart valve Oct. 19, just ahead of the company’s announcement of 9 percent sales growth in the 2012 third quarter. The Sapien transcatheter valve was initially approved in November 2011 for transfemoral placement in patients with inoperable aortic valve stenosis.
Devices & Diagnostics Letter