Medtronic Wins Expanded Indication Trial for CoreValve System

Medtronic received good news from the FDA, which has approved an expanded indication trial for CoreValve Evolut R system aortic stenosis patients who are at a low surgical mortality risk.

The IDE trial is scheduled to begin this spring and is expected to include 1,200 patients with severe aortic stenosis who have less than a 3 percent risk of mortality.

Also available in Europe, the CoreValve Evolut R transcatheter valve and accompanying CoreValve EnVeo R delivery catheter system gained FDA approval last June. — Anisa Jibrell