乌鸦传媒

It's official: the for Edwards Lifesciences' Sapien 3 and Medtronic's Evolut R transcatheter aortic valve replacement (TAVR) devices to include patients in all risk categories.

Patients with severe aortic stenosis who are at low surgical risk may now receive TAVR with the balloon-expandable (regular and Ultra) or the self-expanding product.

Approval follows the "game-changing" PARTNER 3 and Evolut Low Risk trials presented at the American College of Cardiology meeting in March.

"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, in the agency's statement on Friday announcing the decision.

For low-risk patients, PARTNER 3 gave the Sapien 3 superiority over surgery in the rate of combined deaths, strokes, and rehospitalizations at 1 year (8.5% vs 15.1%, P=0.0001 for superiority), whereas Evolut Low Risk showed non-inferiority for Medtronic valves in combined deaths and disabling strokes at 24 months (5.3% vs 6.7%, posterior probability of noninferiority >0.999).

"Low risk patients were younger and healthier than those patients enrolled in our prior studies, and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences," said Jeffrey Popma, MD, of Beth Israel Deaconess Medical Center in Boston, and co-principal investigator in the Evolut Low Risk Trial, in a .

Medtronic suggested that approximately 165,000 low-risk patients per year would be eligible for TAVR in the U.S., Western Europe, and Japan.

Comment