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# FDA Approves Expanded Use for Edwards Heart Valves
- URL: https://www.fdaweb.com/fda-approves-expanded-use-for-edwards-heart-valves/
- Published: 2016-08-19T12:00:00.000Z
- Updated: 2026-09-14T21:25:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136562

FDA has approved an expanded indication for Edwards Lifesciences’ 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. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. “This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,” an FDA news release says.  

Approval was based on data from clinical studies involving over 2,000 aortic stenosis patients at intermediate risk for surgical complications who were randomly selected to have a transcatheter aortic valve replacement procedure using the Sapien XT valve or traditional aortic valve replacement during open-heart surgery using a surgical tissue valve. The studies “demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients,” the agency says.