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Medical Devices / Submissions and Approvals

FDA Approves Expanded Indication for Sapien 3 Artificial Heart Valve for High-Risk Patients

June 7, 2017
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Edwards Lifesciences’ Sapien 3 THV artificial heart valve received FDA clearance for an expanded indication to include treatment for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve.

The FDA originally approved the Sapien 3 THV for transcatheter aortic valve replacement as an alternative to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater.

Valve-in-valve procedures offer an alternative to repeat surgery, since the replacement valve is inserted inside the failing surgical bioprosthetic valve through a patient’s blood vessel or a small cut in a patient’s chest.

Clinical data showed that more than 85 percent of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure. — Cynthia Jessup

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