Irish medical technology firm Medtronic has secured CE mark approval for its CoreValve Evolut R 34mm transcatheter aortic valve implantation (TAVI) system.
The Evolut R 34mm valve, which is now available in Europe, has secured approval for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26-30m.
It will be delivered by using EnVeo R delivery catheter system that features an inline sheath.
The system has been designed to treat patients with smaller vessels through the preferred transfemoral access route.
Featuring self-expanding nitinol frame, the Evolut R system will fit within the native aortic valve through self-expanding nitinol frame, resulting in better hemodynamic performance.
Last October, the firm secured FDA approval for CoreValve Evolut R 34mm valve to treat severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm.
Medtronic cardiac and vascular group’s heart valve therapies business general manager and vice president Rhonda Robb said: "We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size.
"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."