Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.
The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation.
“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a study designed to look at the valve’s longer-term real-world performance. The Evolut PRO has shown exceptional results for patients with severe aortic stenosis and we are excited to enroll our first patients into this rigorous study,” co-principal investigator Dr. Eberhard Grube of Bonn, Germany’s University Hospital said in a prepared statement.
The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. The device designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm
“As new products are introduced to the global transcatheter valve market, Medtronic continues to stay focused on driving meaningful clinical outcomes that matter to patients and that resonate with physicians. We believe the improvements made to the self-expanding Evolut TAVI platform will continue to improve patient outcomes, and we anticipate this real-world study will demonstrate further evidence of longer-term performance and safety,” Medtronic structural heart biz medical affairs president Dr. Pieter Kappetein said in a press release.
In July, Medtronic said it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery.