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FDA Approves SAPIEN 3 Platform for Asymptomatic Severe Aortic Stenosis

Medically reviewed by Carmen Pope, BPharm. Last updated on May 5, 2025.

By Lori Solomon HealthDay Reporter

MONDAY, May 5, 2025 -- The U.S. Food and Drug Administration has approved the SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe aortic stenosis without symptoms. The approval is the first for TAVR in asymptomatic patients.

In the EARLY TAVR trial, which informed the approval, patients with asymptomatic severe aortic stenosis were randomly assigned to either TAVR or watchful waiting. During a median follow-up of 3.8 years, 26.8 percent of the 455 patients in the TAVR group experienced death, stroke, or unplanned cardiovascular hospitalization compared with 45.3 percent of the 446 patients in the clinical surveillance group.

"There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend 'watchful waiting' until symptoms develop," Philippe Genereux, M.D., from the Gagnon Cardiovascular Institute at Morristown Medical Center in New Jersey, said in a statement. "As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the health care system."

Approval of the SAPIEN 3 platform was granted to Edwards Lifesciences.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted May 2025

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