The CE mark has been granted to Medtronic for the 34mm-valve version of its CoreValve Evolut R, the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. The company also announced the European market launch of the device.
The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.
“It is important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients,” says Darren Mylotte, interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland. “Consistent with the Evolut R platform, the 34mm 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.”
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 (16Fr equivalent, approximately 1/5inch or 1/2cm), 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 haemodynamic performance.
The CoreValve Evolut R 34mm valve received US Food and Drug Administration (FDA) approval in the United States in October 2016 for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30mm.