Medtronic has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve implantation (TMVI) system using a minimally-invasive transfemoral access approach. A press release reports that this announcement builds upon primary endpoint outcomes of the Intrepid TMVI clinical trial (APOLLO), which showed that TMVI (via the transapical approach) was feasible and was published in the Journal of the American College of Cardiology (the first-ever trial approved by the FDA to evaluate the safety and efficacy of a TMVI system).
The prospective, multicentre, non-randomised study will evaluate the safety and performance of the Intrepid system with the transfemoral approach in patients with severe, symptomatic mitral regurgitation who are ineligible for conventional mitral valve surgery. The study will enrol and treat up to 15 patients who require mitral valve intervention at up to six centres. 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 TMVI technologies.
The Intrepid TMVI system integrates self-expanding, dual-stent technology with a 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.
Martin B Leon (New York-Presbyterian/Columbia University Medical Center, New York, USA), co-principal investigators of the study, says; “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. The early clinical results we have seen with Intrepid and this early feasibility study advances the TMVI 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.”
Nina Goodheart, vice president and general manager, Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic, comments: “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.”