Medtronic (NYSE:MDT) this week touted data for its Intrepid self-expanding transcatheter mitral valve replacement (TMVR) system.
Early data from 15 patients in an early feasibility study was presented as late-breaking clinical science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. The study evaluated patients with severe, symptomatic mitral valve regurgitation (MR) utilizing the transfemoral access route.
According to a news release, the Intrepid transfemoral system showed 100% survival and no stroke with a median procedure time of 46 minutes and none/trace MR in all implanted patients at 30 days. The data were published simultaneously in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.
Intrepid TMVR, which holds FDA breakthrough device designation for patients unsuitable for transcatheter edge-to-edge repair or mitral valve surgery, uses self-expanding, dual-stent technology with a replacement tissue heart valve to facilitate catheter-based implantation.
The platform uses a delivery catheter to insert the valve into the heart before the new replacement valve is expanded directly into the malfunctioning mitral valve. Medtronic designed the outer stent frame to attach and conform to the native valve without the need for additional sutures, tethers or anchors. The inner stent contains the valve made from bovine tissue designed to maintain blood flow.
Medtronic is evaluating the Intrepid TMVR system in the Apollo trial, which includes one cohort evaluating patients with primary or secondary MR who are unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER) and a second cohort is evaluating patients with severe symptomatic MR who are deemed ineligible for conventional mitral valve surgery with mitral annular calcification (MAC).
“The development of the Intrepid transfemoral delivery system is an important milestone for the Intrepid TMVR program and we are excited to introduce it into the Apollo Trial,” Medtronic SVP & President of its Structural Heart & Aortic business Nina Goodheart said in the release. “We believe this advancement will expand our clinical trial offerings to more patients.”