CE Mark Approved for Medtronic's Recapturable CoreValve Evolut R System

September 3, 2014—Medtronic, Inc. announced European CE Mark approval for the 23-mm CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR). The device features a self-expanding valve and 14-F-equivalent delivery system that offers new capabilities and provides the option to recapture and reposition the valve during the deployment phase, if needed.

According to Medtronic, the new system includes the CoreValve Evolut R transcatheter aortic valve and the EnVeo R delivery catheter system, which is designed for first-time positioning accuracy. Also, the new InLine sheath significantly reduces the profile to the lowest on the market (14-F equivalent), which is believed to minimize the risk of major vascular complications. The new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing while maintaining supra-annular valve position for improved hemodynamic performance.

The 23-mm CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system are now available in Europe and other countries that recognize the CE Mark. It is not approved for commercial use in the United States, where it is currently undergoing clinical trials, advised Medtronic.

In Medtronic’s announcement, Eberhard Grube, MD, commented, “The CoreValve Evolut R System offers improvements to a proven TAVR technology platform. The system’s new recapture-enabled capabilities and advancements in valve delivery provide physicians with added procedural confidence. It’s a significant advance to know there is the option to redeploy the valve in the ideal position if necessary.” Dr. Grube leads the Center of Innovative Interventions in Cardiology at University Hospital Bonn, Germany.