Medtronic launches Evolut R 34 mm TAVR system in Europe

Medtronic announced that it had received a CE mark for its Evolut R 34 mm transcatheter aortic valve replacement (TAVR) system.

The company also said in the Jan. 17 news release that it had launched the valve in Europe.

The system was approved for patients with severe aortic stenosis who are at intermediate, high or extreme risk for surgery and have an annulus size from 26 to 30 mm. Medtronic said that approximately 20 to 25 percent of Europeans eligible for TAVR fit into that category.

The valve is delivered through a catheter and features a self-expanding nitinol frame designed to fit within the native aortic valve.

The FDA approved the Evolut R 34 mm TAVR system in October. The agency originally approved the system in June 2015 in 23 mm, 26 mm and 29 mm sizes.