First Recapturable Heart Valve Receives FDA Approval

The FDA today approved Medtronic’s recapturable and self-expanding CoreValve Evolut R System for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at higher or extreme risk for surgery.

According to Medtronic, the Evolut R System is the first and only recapturable and repositionable device available in the nation.

The system uses an InLine Sheath that gives it a smaller profile size, allowing for greater ability to treat patients with smaller vessels through the preferred transfemoral access route, Medtronic noted. Evolut R was also designed to increase conformability and sealing at the annulus, while still allowing for supra-annular valve positioning for improved blood flow.

"Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned,” said Mathew Williams, MD, study investigator and chief of Adult Cardiac Surgery and director of Interventional Cardiology and Structural Heart at the NYU Langone Medical Center, in a press release. “The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are non-existent in other TAVR systems."

Aortic valve stenosis, which causes limited blood flow from the aorta to the rest of the body, may lead to heart failure or death if left untreated.

The 23 mm, 26 mm, and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are now available.