Medtronic Unveils New Data From Intrepid Transcatheter Mitral Valve Replacement Program to Expand Treatment Options for Severe Mitral Regurgitation

Late-breaking data from Intrepid™ Pilot Study shows positive 3-year outcomes 

September 18, 2022 — Medtronic today announced new data of the Intrepid transcatheter mitral valve replacement   (TMVR) system, including late-breaking results from the Intrepid™ Pilot Study and Intermediate-Term Outcomes of the Intrepid Early Feasibility Study (EFS) at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. Furthering evidence for the Intrepid TMVR system, the data offers new clinical insights supporting transapical and transfemoral approaches using the Medtronic Intrepid TMVR System for the treatment of mitral regurgitation (MR).  

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.

“With the Intrepid TMVR system, our goal is to ultimately offer viable alternative options for patients who are considered inoperable for surgical mitral regurgitation replacement,” said Nina Goodheart, vice president and general manager, Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. “The data presented at TCT builds on initial results from the Intrepid TMVR Pilot Study and is another step forward in our mission to provide safe and effective delivery options for patients with mitral valve disease.”

The Intrepid TMVR 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. 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. 

Late-Breaking Clinical Science: Intrepid Pilot Study Mid-Term Outcomes

Presented as Late-Breaking Clinical Science, results from the Intrepid Pilot Study provide the longest follow-up from the largest series of inoperable patients with severe, symptomatic MR treated with a transapical TMVR system. The study assessed the safety and performance of the Intrepid TMVR using a transapical delivery. A transapical approach uses a small incision in the chest to perform aortic valve replacement, rather than the leg.

Results from the prospective, multi-center, non-randomized Intrepid Pilot study demonstrated positive outcomes of the transapical MV replacement with the Intrepid TMVR system. At three-years, echocardiographic outcomes showed stable valve function with low mean mitral valve gradients, persistent MR reduction with less than 98% of patients with paravalvular leak, and significant reduction in left ventricular end diastolic volume.  

“The data presented at TCT adds to the growing body of evidence demonstrating the Intrepid TMVR System is a promising long-term solution for patients with severe, symptomatic MR, who are at high risk for conventional mitral valve surgery,” said Renuka Jain, M.D., cardiologist with Aurora St. Luke’s Medical Center and investigator in the Intrepid Pilot Study.

Innovation Session: Intrepid Early Feasibility Study Intermediate-Term Outcomes

Medtronic announced Intermediate-Term Outcomes of the Intrepid EFS, the first study of a minimally-invasive transfemoral bioprosthetic TMVR system to treat MR. Findings of the prospective, multicenter, non-randomized EFS were presented as part of the Mitral Innovation Session at TCT. 

The analysis includes 30-day outcomes from the Intrepid EFS and the first one-year results for 14 patients, demonstrating successful device implantation and valve performance. Results include: 

• High rates of successful device implantation (96.7%)
• Device safety with acceptable rates of periprocedural complications (27%) and no mortality or stroke (0%)
• Excellent valve performance including near complete elimination of MR in all patients (91%)
• Improved symptoms and QoL 

“We are encouraged by these early results for the Intrepid TMVR system using the novel transfemoral and look forward to evaluating and furthering evidence around the clinical outcomes and hemodynamics of the device,” said Firas Zahr, M.D., interventional cardiologist and co-director of the Complex Heart Valve Program at Oregon Health & Science University and principal investigator. “These results can help to establish TMVR as a safe treatment option for patients that are high-risk for conventional surgical approaches.” 

The Intrepid TMVR system is available for investigational use only and it is not approved anywhere for use outside of clinical studies. As part of its commitment to developing solutions for the treatment of valve disease, Medtronic is sponsoring and currently enrolling participants to the landmark APOLLO Trial. APOLLO is designed to evaluate the safety and efficacy of the Intrepid system in correcting MR.