FDA Grants Expanded Indication for Transcatheter Heart Valves

The FDA has approved an expanded indication for several transcatheter heart valve devices to include patients with low risk of severe aortic valve stenosis, a valve disease problem in which the aortic valve’s opening narrows.

The transcatheter valves included in the agency’s decision — Edwards’ Sapien 3 and Sapien 3 Ultra and Medtronic’s CoreValve Evolut R and CoreValve Evolut Pro — had been indicated only for patients at mid- to higher risk of major complications or death during open-heart surgery.

The new approval “significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, director of CDRH’s Office of Cardiovascular Devices.