The FDA approved Medtronic’s latest iteration of its CoreValve Evolut transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis in patients too frail for open-heart surgery.
Built on the proven platform of the recapturable CoreValve Evolut R System, the Evolut PRO valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent hemodynamic performance.
Based on Medtronic’s CoreValve system, the Evolut Pro TAVR is recapturable and repositionable—once placed, it may be retrieved and moved using the delivery catheter. It has a new design to improve sealing and reduce leaking around the edges of the implant. It has an outer wrap made of biocompatible porcine pericardial tissue—the membrane that surrounds the heart—that increases the surface area of contact between the valve and the aorta, Medtronic said in a statement.
"This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases,” said Mathew Williams, M.D., chief of Adult Cardiac Surgery and director of Interventional Cardiology in the Heart Valve Program at the NYU Langone Medical Center, in the statement.
The FDA nod comes after Medtronic unveiled 30-day data indicating high survival, “minimal” leakage and “excellent” blood flow. In the 60-patient trial, there was a disabling stroke rate of 1.7%, while nearly three-quarters of the patients reported no severe paravalvular leak.
"The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery," said John Forrest, M.D., assistant professor of medicine at Yale University School of Medicine, who presented the data at the American College of Cardiology meeting.