Medtronic (SWX:MDT) has announced that it has initiated a post market clinical evaluation of its CoreValve Evolut Pro valve.
The newly announced clinical study of the CoreValve Evolut Pro valve will evaluate its performance based on day to day clinical use. The clinical study will also involve the participation of patients suffering from severe symptomatic aortic stenosis especially those that have a moderate or severe risk of open heart surgery. The evaluation will determine the performance for a duration of five years as it ushers in the future self-expanding TAVI system which recently received approval for use in the U.S and Europe.
“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,” stated Dr. Eberhard Grube of Bonn, the co-principal investigator for the clinical study.
The evaluation will be a single-arm study that will involve multiple centers. It also aims to involve 600 patients from 35 European locations in determining the safety of the offering. The CoreValve Evolut Pro consists of an outer wrap that contributes to the surface area between the native aortic annulus and the valve in order to boost the valve sealing performance. The company also revealed that the device features a small form factor to allow for easy delivery through the EnVeo R delivery catheter system.
Dr. Pieter Kappetein, the president of structural heart biz medical affairs at Medtronic pointed a few critical points during a press release. He highlighted that it is his company’s agenda to continue pushing towards meaningful clinical outcomes that are vital for patients as new products enter the global transcatheter valve market. He also added that the outcomes also have to resonate with the physicians and that the company is optimistic that the enhancements featured in the self-expanding Evolut TAVI platform will facilitate better outcomes for patients. Medtronic also hopes that the study will contribute provide evidence of long-term safety and performance.