Fridley, Minn.-based Medtronic said the approval opens the CoreValve Evolut R transcatheter aortic valve replacement as an option for some 20% to 25% of patients with diseased aortic valves. The the valve originally won CE Mark approval in September 2014; the FDA approved the device in July 2015 and gave the 34 mm size a nod last October.
“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,” heart valve therapies GM Rhonda Robb said in prepared remarks. “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.”
“It’s important that patients with large aortic root anatomies can also have access to this recapturable [TAVR] system, which has proven to be an excellent treatment option for many patients,” added Dr. Darren Mylotte of the National University of Ireland in Galway. “Consistent with the Evolut R platform, the 34 mm 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.”