Medtronic's Intrepid Transfemoral TMVR system evaluated in Early feasibility study.

Presented as Late-Breaking Clinical Science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation, 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 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.

The Intrepid valve has been used to treat more than 350 patients as part of global clinical trials. Currently, the Medtronic APOLLO Trial is evaluating the Intrepid TMVR system in patients with severe MR with 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 (MAC). To date, patients enrolled in the study have received the Intrepid TMVR system using the transapical access route where the valve is compressed inside a hollow catheter and inserted between the ribs into the heart. With IDE approval, APOLLO study investigators will now have the additional option to insert the valve via an incision in the groin into the femoral vein, which has historically been the preferred approach for most transcatheter procedures.

Mitral regurgitation (MR) occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, MR can lead to heart failure or death. Due to the complexity of the mitral valve anatomic structure and multiple comorbidities typically present in such patients, limited medical therapies are available to clinicians and their patients.

Using a delivery catheter to insert the valve into the heart, the new replacement valve is expanded directly into the malfunctioning mitral valve. The 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 and is intended to maintain blood flow..

See-Zahr F, Song HK, Chadderdon SM, et al.":Thirty-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results". JACC Cardiovasc Interv 2021;Nov 3:[Epub ahead of print].