The Cardiothoracic Surgery Department’s Heart Valve Center at NYU Langone Medical Center became the first centre in the world to implant a new heart valve for transcatheter aortic valve implantation (TAVI) in a patient with severe aortic stenosis—the Medtronic CoreValve Evolut PRO TAVI system. A press release reports that the centre is leading the advancement of new technology to help patients suffering from aortic stenosis who are at high to extremely high surgical mortality risk.
According to the press release, Mathew R Williams (a cardiac surgeon in the Department of Cardiothoracic Surgery at NYU Langone) and others performed the performed the first-ever TAVI procedure using the new investigational device on 2 June. The patient was discharged to her home the next day.
The press releases notes that the new TAVI system retains the key advantages of the Evolut R, as it is both recapturable and repositionable, so accuracy in placement and control during the procedure is increased. In addition to these advantages, the Evolut PRO TAVI system is designed with an added outer layer, a porcine pericardial skirt. The clinical study will evaluate the ability of the outer portion of the device to further improve paravalvular leakage around the implant.
Williams says: “This new technology represents an innovative advancement on an already-approved device that we hope with more study will become a new option for patients with severe aortic stenosis who are at extremely high risk for surgery. As established leaders in the field of cardiac surgery and advancing the field through research and participation in cutting-edge clinical trials, we are uniquely qualified to treat patients who would otherwise have very limited options, and help them return to their normal lives within only weeks of surgery.”
NYU Langone previously led the clinical trials for the Evolut R device, which was approved by FDA in June 2015, and was one of the top centres for Evolut R trial enrolment nationally.