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Sapien Heart Valve Gets FDA Panel Nod For High-Risk Surgical Patients

Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.

FDA’s Circulatory System Devices panel supported Edwards Lifesciences’ effort to expand labeling for its Sapien transcatheter heart valve replacement to patients at high risk when undergoing conventional open heart valve surgery.

The panel voted 10-2 June 13 that there was a reasonable assurance of safety and 12-0 that there was a reasonable assurance of effectiveness. Eleven of the FDA advisors voted...

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