Edwards' Sapien 3 TAVR Systems Receive FDA Approval for Low-Risk Patients

August 16, 2019—Edwards Lifesciences announced FDA approval to expand use of the company's Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) systems to the treatment of severe, symptomatic aortic stenosis patients who are determined to be at low risk of open heart surgery.

According to the company, the Sapien 3 low-risk approval was based on data from the landmark PARTNER 3 randomized clinical trial comparing outcomes between TAVR and open heart surgery. TAVR with the Sapien 3 system achieved superiority, with a 46% reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke, and rehospitalization at 1 year.

Martin B. Leon, MD, National Coprincipal Investigator of the PARTNER 3 trial, presented the 1-year data at the American College of Cardiology's 68th Annual Scientific Session held March 16–18, 2019, in New Orleans, Louisiana. The findings were simultaneously published by Michael J. Mack, MD, et al in The New England Journal of Medicine (2019;380:1695–1705).

In the Edwards announcement, Dr. Leon commented, "The PARTNER 3 trial demonstrated that low-risk patients treated with the Sapien 3 TAVR experienced extraordinary outcomes with 1.0% rates of death or disabling stroke at 1 year, a short length of stay, and 96% discharged to home or self-care. Sapien 3 is the only valve to achieve superiority over surgery based on the prespecified primary endpoint."

Dr. Leon added, "Today's FDA approval of Sapien 3 TAVR will expand access to this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe AS patients." Dr. Leon is Director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons in New York, New York.