FDA greenlights early feasibility study for less-invasive TMVR system

Medtronic announced Sept. 27 that it had received FDA approval to launch an early feasibility study (EFS) for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally invasive transfemoral access approach.

According to a statement from the company, the new Medtronic trial will build upon results from its Intrepid TMVR pilot study, which used a transapical approach and was the first-ever study approved by the FDA to evaluate the safety and efficacy of a TMVR system. Intrepid TMVR reportedly restores healthy blood flow to the heart by integrating self-expanding, dual-stent technology with a tissue valve that’s delivered via catheter directly to a patient’s native mitral valve, circumventing the need for open-heart surgery.

The EFS will be a prospective, multi-center, non-randomized trial that will evaluate the safety and performance of the Intrepid system in patients with severe symptomatic mitral regurgitation. Patients with severe MR are often considered ineligible for conventional mitral valve surgery.

Medtronic plans to enroll and treat up to 15 patients at up to six centers for the EFS, following up with them at one, three, six and 12 months and then every six months after that for five years.

“We are optimistic about the potential benefits of the transfemoral approach for mitral valve replacement—which is less invasive than the transapical technologies currently in pivotal trials,” national co-principal investigator Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbytarian/Columbia University Medical Center, said in a statement. “The early clinical results we have seen with Intrepid and this early feasibility study advances the TMVR field as we look for less invasive ways to treat this patient population, of which a large proportion are considered too high-risk for surgery.”

Medtronic stressed in its announcement that the Intrepid TMVR system is being used solely in an investigational capacity and hasn’t yet been approved for commercial use.