Edwards Transcatheter Heart Valves Approved in Intermediate-Risk Patients

August 22, 2016

In an industry first, the FDA approved an expanded indication for transcatheter heart valves for patients with aortic valve stenosis at intermediate risk for death or complications from open heart surgery.

Previously, transcatheter heart valves were only approved for patients at high or greater risk for death or complications from surgery. Roughly one-third of patients referred for open-heart surgery for aortic valve replacement fall into the intermediate-risk category. Patients with severe aortic valve stenosis generally need heart valve replacement to improve blood flow.

Open-heart surgery has been the gold standard for aortic valve replacement in intermediate risk patients, but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the transcatheter heart valve.

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