Medtronic plc announces the CE Mark and European launch of the CoreValve Evolut R 34 mm valve-the largest sized transcatheter aortic valve implantation (TAVI) system available.

Medtronic plc announced the CE (Conformit� Europ�enne) mark and European launch of the CoreValve Evolut R 34 mm valve-the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. 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 26-30 mm. This large valve segment is estimated to account for approximately 20-25 percent of the eligible European TAVI patient population Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.

The Evolut R 34mm valve is delivered through the EnVeo R Delivery Catheter System, which features an InLine Sheath. The system delivers the lowest, true delivery profile currently on the market (16 Fr equivalent, approximately 1/5 inch or 1/2 cm), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance.

Comment:With this approval, the Evolut R platform now treats the broadest annulus range of any TAVI system on the market and expands the patient population that can now receive this life-saving therapy.