Medtronic has launched its 23 mm CoreValve Evolut R System for transcatheter aortic valve implantation in European and other CE mark countries. The self-expanding valve and delivery system allows physicians to reposition it during placement if needed, the company says.
The InLine sheath is designed for first-time positioning accuracy at less than a fifth of an inch, giving it the lowest profile on the market and minimizing the risk of major vascular complications, Medtronic says. The valve is anatomically designed to provide optimal annular fit and sealing, and helps to maintain supra-annular valve position for improved hemodynamic performance, the devicemaker adds.
Eberhard Grube, head of the Center of Innovative Interventions in Cardiology at University Hospital in Bonn, Germany, called the CoreValve Evolut R System redeployment option a “significant advance” in valve placement technology.
U.S. clinical trials of the system are underway and will be used to support marketing approval here. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.