Medtronic's CoreValve Evolut R 34-mm TAVR System Approved in Europe

January 17, 2017–Medtronic announced European CE Mark approval and the European launch of the CoreValve Evolut R 34-mm transcatheter aortic valve replacement (TAVR) system. The new Evolut R 34-mm valve is approved for severe aortic stenosis patients who are at intermediate, high, or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.

Medtronic stated that the Evolut R 34-mm valve is delivered through the EnVeo R delivery catheter system, which features an InLine sheath. The system’s true delivery profile is 16-F equivalent, which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.

In the company’s announcement, Darren Mylotte, MD, commented, “It’s important that patients with large aortic root anatomies can also have access to this recapturable TAVR system, which has proven to be an excellent treatment option for many patients. Consistent with the Evolut R platform, the 34-mm valve delivery system assists with accurate placement with the option to recapture and reposition if needed; this gives physicians great confidence that exceptional outcomes can be achieved for our patients.” Dr. Mylotte is an interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland.

In October 2016, Medtronic announced that the CoreValve Evolut R 34-mm valve received US Food and Drug Administration approval for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.