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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today presented early data for its self-expanding Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System in patients with severe, symptomatic mitral regurgitation (MR) via the transfemoral access route. Transcatheter Cardiovascular Therapeutics (TCT) Conference, the annual scientific symposium of the Cardiovascular Research Foundation, presented as Late-Breaking Clinical Science. Data from the first 15 patients enrolled in an early feasibility study of the Intrepid Transfemoral System showed 100% survival and no stroke, a median procedure time of 46 minutes, and no/barely 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.

“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,” commented Firas Zahr, M.D., interventional cardiologist and co-director of the Complex Heart Valve Program at Oregon Health and Science University and investigator in the study. “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.”

Mitral regurgitation (MR) occurs when blood flows back through the mitral valve into the atrium with each contraction of the left ventricle. If left untreated, MR can lead to heart failure or death. Because of the complex anatomical structure of the mitral valve and the numerous comorbidities that typically occur in these patients, there are limited medical therapies available to physicians and their patients.

The Intrepid valve has been used in more than 350 patients in worldwide clinical trials. Currently, the Medtronic APOLLO study is evaluating the Intrepid TMVR system in patients with severe MR. One cohort is studying patients with primary or secondary MR, who are not suitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). A second cohort is studying patients with severe symptomatic MR who are considered unsuitable for conventional mitral valve surgery with mitral annular calcification (MAC). To date, patients enrolled in the study have received the Intrepid TMVR system via the transapical approach, in which the valve is compressed in a hollow catheter and inserted into the heart between the ribs. With the approval of IDE, investigators in the APOLLO study now have the additional option of inserting the valve into the femoral vein via an incision in the groin, which has historically been the preferred access for most transcatheter procedures.

The Intrepid TMVR System, which has received Breakthrough Device Designation from the FDA (for patients ineligible for transcatheter edge-to-edge repair or mitral valve surgery), integrates self-expanding dual-stent technology with a replacement tissue heart valve to enable catheter-based implantation. The new replacement valve is inserted into the heart using an introducer catheter and expanded directly into the defective mitral valve. The outer stent frame is designed to hug the native valve without the need for additional sutures, ligaments, or anchors to secure the prosthesis. The inner stent houses the valve, which is made of bovine tissue and is designed to maintain blood flow.

“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,” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic. “We believe this advancement will expand our clinical trial offerings to more patients.”

The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical studies.