9/1/2020
Early Feasibility Study of the Transcatheter Mitral Valve Repair (TMVR) Transseptal System Now Underway at UPMC Pinnacle
HARRISBURG, Pa. – UPMC today announced it is the first health system in central Pennsylvania and second in the U.S. to treat a patient as part of a study evaluating the safety and performance of a new system for those patients ineligible for conventional mitral valve surgery. The Early Feasibility Study of the TMVR Transseptal System is designed to evaluate transseptal/transfemoral access of the Intrepid™ TMVR system in patients with severe, symptomatic mitral valve regurgitation.
The first patient treated at UPMC Pinnacle Harrisburg was implanted by the team of Hemal Gada, M.D., medical director of structural heart and interventional cardiologist, Mubashir Mumtaz, M.D., F.A.C.S., F.A.C.C., chief of cardiothoracic surgery and surgical director of structural heart; and Amit Vora, M.D., M.P.H., associate director of the structural heart program.
“UPMC Heart and Vascular Institute remains at the forefront of participating in the early phases of clinical trials for promising less-invasive therapies to address the need for better heart failure treatment,” said Dr. Gada. “Clinical trials like this one give our patients access to new treatments and keep our heart and vascular team attuned to the latest research and therapeutics. We are hopeful that the TMVR Transseptal system will provide a new, less invasive way to treat this patient population, of which a large proportion are considered too high risk for surgery.”
Mitral regurgitation occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, mitral regurgitation 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.
The Intrepid™ TMVR system integrates self-expanding, dual-stent technology with a replacement tissue heart valve to facilitate a catheter-based implantation. The Intrepid™ valve is compressed inside a hollow delivery catheter which is guided through the femoral vessel and across the septum of the heart to reach the mitral valve. 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.
The Early Feasibility Study of the TMVR Transseptal System will enroll and treat up to 15 patients within the United States with severe, symptomatic mitral regurgitation. The primary objective is to evaluate the safety of the implant and delivery system, with secondary objectives measuring quality of life and valve performance.
The Intrepid™ TMVR system is available for investigational use only and it is not approved for use outside of clinical studies.