Medtronic has secured CE mark for its transcatheter aortic valve implantation (TAVI) system, the CoreValve Evolut R 34mm valve and will subsequently launch it in Europe.
Delivered through the EnVeo R Delivery Catheter System, featuring an InLine Sheath, the Evolut R 34mm valve enables treatment of patients with smaller vessels through the preferred transfemoral access route.
The system features a self-expanding nitinol frame which has been designed to fit within the native aortic valve, using its supra-annular valve position ensuring improved hemodynamic performance.
The new Evolut R 34mm valve is indicated to be used for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm.
University Hospitals and National University of Ireland interventional cardiologist Darren Mylotte said: "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.
"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 valve system is expected to be applicable to about 20-25% of the eligible European TAVI patient population, which will include patients who previously were unable to receive a TAVI due to the larger size of their native diseased aortic valve.