FDA Approves Medtronic's CoreValve Evolut R 34-mm Recaptureable TAVR System

October 26, 2016—Medtronic plc announced the US Food and Drug Administration (FDA) approval and United States launch of the CoreValve Evolut R 34-mm transcatheter aortic valve replacement (TAVR) system. The new Evolut R 34-mm valve is approved for treatment of severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm. The CoreValve Evolut R 34-mm valve is only approved in the United States and is not approved in Europe and other countries, advised Medtronic.

Mathew Williams, MD, Coprimary Investigator for the Evolut 34-mm clinical study, commented in the company’s announcement, “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. 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.” Dr. Williams is Chief of Adult Cardiac Surgery and Director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York, New York.

The Evolut R 34-mm valve is delivered through the EnVeo R delivery catheter system, which features the company’s InLine sheath. The system’s true delivery profile is 16F, which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R system is designed with a self-expanding nitinol frame to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance, stated the company.