Medtronic's Intrepid Transfemoral TMVR System Evaluated in Early Feasibility Study

November 6, 2021—Medtronic plc announced the presentation of early data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral regurgitation (MR) via transfemoral access.

The data from the first 15 patients enrolled in the early feasibility study of the Intrepid transfemoral system showed 100% survival, no stroke, a median procedure time of 46 minutes, and none/trace MR at 30 days in all patients who received the implantation of the device.

The early feasibility study findings were presented at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 both online and in Orlando, Florida. The study was published simultaneously online Firas Zahr, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

Dr. Zahr commented in Medtronic's press release, "These data indicate that the new Intrepid transfemoral delivery system is a promising option for the delivery of the Intrepid valve with all patients in the study showing almost complete elimination of MR at 30 days. The addition of transfemoral access into the APOLLO trial will provide study investigators with an access route that could present less risk to patients during the procedure." Dr. Zahr is an interventional cardiologist and co-director of the Complex Heart Valve Program at Oregon Health and Science University in Portland, Oregon.

The Intrepid TMVR system, which has been used to treat more than 350 patients in global clinical trials, is available for investigational use only and it is not approved for use outside of clinical studies, advised Medtronic.

The company stated that the Medtronic APOLLO trial currently is evaluating the Intrepid TMVR system in patients with severe MR. One cohort evaluating patients with primary or secondary MR who are unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). A second cohort is evaluating patients with severe symptomatic MR who are deemed ineligible for conventional mitral valve surgery with mitral annular calcification.

To date, patients enrolled in the study have received the Intrepid TMVR system using the transapical access route. With investigational device approval from the FDA, the APOLLO study investigators will now have the transfemoral option.

According to Medtronic, the Intrepid TMVR system received FDA Breakthrough Device designation for patients unsuitable for TEER or mitral valve surgery. The device integrates self-expanding, dual-stent technology with a replacement tissue heart valve to facilitate a catheter-based implantation. The Intrepid's outer stent frame is designed to attach and conform to the native valve without the need for additional sutures, tethers, or anchors to secure the prosthesis. The inner stent houses the valve, which is made from bovine tissue, note the company.