Medtronic (NYSE:MDT) said today that it has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally-invasive transfemoral access approach.
The announcement builds upon primary endpoint outcomes of the Intrepid TMVR Apollo clinical trial using the transapical approach, published in the Journal of the American College of Cardiology. In that study, 48 of 50 high-risk patients were successfully implanted with Intrepid. Mortality at 30 days was 14% with no disabling strokes or repeat interventions.
Apollo is the first-ever trial approved by the FDA to evaluate the safety and efficacy of a TMVR system, according to Fridley, Minn.-based Medtronic.
The prospective, multi-center, non-randomized early feasibility study will evaluate the safety and performance of the Intrepid TMVR System with the transfemoral approach in patients with severe, symptomatic mitral regurgitation who are ineligible for conventional mitral valve surgery. The study will enroll and treat up to 15 patients who require mitral valve intervention at up to six centers. Treated patients will be followed up at one, three, six and 12 months, and every six months thereafter through five years. The results from this study will inform the development of next-generation transfemoral TMVR technologies, according to Medtronic.
“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,” said national co-principal investigator Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center. “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.”
Procedural treatment options for mitral regurgitation patients are limited. If left untreated, mitral regurgitation may lead to chronic heart failure.
The Intrepid TMVR system integrates self-expanding, dual-stent technology with a bovine tissue valve that is delivered through a catheter and placed directly into the native mitral valve to restore normal blood flow through the heart without the need for open-heart surgery, the company said.
“Medtronic believes that transcatheter mitral valve replacement will have a vital role in treating patients with mitral valve disease and this early feasibility study is another step forward in our Intrepid program,” said Nina Goodheart, VP & GM of Medtronic’s structural heart business, in a news release.
The Intrepid TMVR system is available for investigational use only and it is not approved anywhere for use outside of clinical studies.