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FDAnews Device Daily Bulletin
Nov. 2, 2012 | Vol. 9 No. 216
FDA Approval of New Valve Indications May Save Edwards Sales Projections
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.
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