FDA Grants Approval for Expanded Indication for 2 Transcatheter Heart Valves

The FDA approved Edwards Lifesciences’ expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery.

According to the clinical studies, these transcatheter heart valves demonstrated a reasonable assurance of safety and effectiveness in intermediate risk patients.

The FDA also submitted an approval condition requiring the manufacturer to conduct a post-approval study to follow the patients treated with either device in the first and second clinical studies for 10 years to further monitor safety and effectiveness. — Cynthia Jessup