October 26, 2016 — Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut R 34 mm valve, now the largest sized transcatheter aortic valve replacement (TAVR) system available in the United States.
The new valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. Previously, some of these patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve.
"We're pleased to have more options to offer patients suffering from severe aortic stenosis who are at high risk or unable to have open-heart surgery," said Mathew Williams, M.D., co-primary investigator for the Evolut 34mm Clinical Study, and chief of adult cardiac surgery and director of interventional cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York City. "This new, larger valve offers patients with larger anatomical structures access to TAVR. For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure."
The Evolut R 34mm valve is delivered through the EnVeo R Delivery Catheter System, which features an inline sheath. The system delivers the lowest, true delivery profile currently on the market, according to Medtronic, (16 Fr equivalent, approximately 1/5 inch), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance.
The CoreValve Evolut R 34 mm valve is only approved in the United States and not approved in Europe and other countries.
For more information: www.medtronic.com