Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its CoreValve Evolut R implantable heart valve in patients at low risk for adverse events from traditional heart valve replacement surgery.
The expanded indication means a likely spring debut for the 1,200-patient trial in patients with severe aortic stenosis with a less than 3% chance of dying with surgical valve replacement. The CoreValve Evolut R is a transcatheter aortic valve implant that’s already been approved in the U.S. for high- and extreme-risk patient cohorts.
The primary endpoint for the trial is slated to be all-cause mortality or disabling stroke at 2 years, but includes a provision for a 1-year analysis for early submission to the FDA, Fridley, Minn.-based Medtronic said. The study is also designed to evaluate a sub-group of 400 patients for leaflet mobility, a complication associated with the risk for blood clots that prompted an FDA warning late last year.
Enrollment in the trial is due to begin this spring, the company said.
“Medtronic is committed to expanding access to [transcatheter aortic valve replacement] for patients who may benefit based on a robust clinical evidence portfolio,” heart valve therapies general manager Rhonda Robb said in prepared remarks. “We are excited to partner with such proven heart teams to study the CoreValve Evolut R self-expanding platform in this low risk patient population.”
“This trial comes on the heels of data showing patients who underwent TAVR with this self-expanding platform demonstrated superior survival benefit -with low and stable stroke rates- compared to SAVR patients,” added principal investigator Dr. Michael Reardon of the Houston Methodist DeBakey Heart & Vascular Center. “This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
Earlier this month, the FDA granted an expanded indication for the CoreValve devices for patients with end-stage renal disease and low-grade, low-flow aortic stenosis.