FDA OKs Expanded Indication for Transcatheter Heart Valves

The FDA has approved an expanded indication for Medtronic’s and Edwards Lifesciences’ transcatheter heart valves to include low-risk patients with severe aortic valve stenosis.

The heart valves – Edwards’ Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously only approved for patients at intermediate or higher risk of death or serious complications during open-heart surgery to replace the damaged valves.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement,” said Bram Zuckerman, director of the FDA’s Office of Cardiovascular Devices.