The Food and Drug Administration (FDA) has approved an expanded indication for several transcatheter aortic valve replacements (TAVR) – Edwards Lifesciences’ Sapien 3, Sapien 3 Ultra and Medtronic’s CoreValue Evolut R, CoreValue Evolut PRO – to include patients with severe aortic valve stenosis who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. Previously, these transcatheter valves were only indicated for patients at intermediate or higher risk for death or major complications during open-heart surgery.

The approval was based on data from the landmark PARTNER 3 and the Evolut Low Risk trials that evaluated the safety and efficacy of TAVR compared with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at low risk for surgical complications. 

Results showed that treatment with Sapien 3 in the PARTNER 3 study (N=1000) achieved superiority vs SAVR, with a 46% reduction in the event rate for its primary end point of all-cause mortality, stroke and rehospitalization at 1 year. Findings from the Evolut Low Risk trial (N=1403) showed that treatment with Medtronic’s CoreValue Evolut R or CoreValue Evolut PRO transcatheter valve was noninferior to surgery when comparing rates of all-cause mortality or disabling stroke (primary end point) at 24 months (5.3% vs. 6.7%, respectively; P <.05). 

Full detailed data from both studies were presented in March at the American College of Cardiology 68th Annual Scientific Session and published in the New England Journal of Medicine


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“This 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, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

According to the FDA, each manufacturer will be required to follow patients enrolled in their studies for 10 years to ensure the safety and efficacy of their devices. The manufacturers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide the agency with additional surveillance of these devices over a 10-year period.

For more information visit fda.gov.