Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for Evolut Pro+, the latest iteration of its transcatheter aortic valve replacement device.
Last month, the FDA granted approval to TAVR devices in patients at low risk from open valve replacement surgery, including the Evolut Pro line and competing devices made by Edwards Lifesciences (NYSE:EW). Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for predecessor valve Evolut Pro in July 2017.
Medtronic touted the newest version’s four valve sizes as offering the broadest annulus range and lowest delivery profile on the U.S. market.
“We anticipate the Evolut Pro+ TAVR system will help heart teams fine-tune their TAVR procedures, further building on the consistent and reliable outcomes that they have come to expect from the Evolut TAVR platform – including positive hemodynamic outcomes in part, due to its supra-annular valve design – which we continue to see with the Evolut platform across large-scale, randomized clinical trials,” structural heart & cardiac surgery CMO Dr. Pieter Kappetein said in prepared remarks. “In addition to a decrease in profile for the core sizes to help minimize burden on the vessels during the procedure, the Evolut Pro+ TAVR system gives heart teams a familiar technology that’s been fine-tuned to help drive excellent patient outcomes.”
“As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy,” added Dr. Mathew Williams, of New York City’s NYU Langone Health. “Valve technologies that are designed to help minimize paravalvular leak, simplify the valve delivery during the procedure, and for unobstructed blood flow are factors that have made TAVR an excellent choice for many patients.”
“Physicians are treating a broader range of patient anatomies than ever before – from large to small, from simple to complex,” Dr. Guilherme Attizzani, of Cleveland’s University Hospitals, said in the release. “Adding the external tissue wrap to the large 34mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.”
