September 9, 2020
Medtronic Begins Early Feasibility Study of Intrepid System to Treat Tricuspid Valve Regurgitation
September 9, 2020—Medtronic announced FDA approval of an early feasibility study of the Intrepid transcatheter tricuspid valve replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation. The company recently received FDA Breakthrough Device designation for the Intrepid TTVR system, which is an investigational device worldwide.
The company advised that Azeem Latib, MD, and Vinayak (Vinnie) Bapat, MD, are the Coprincipal Investigators of the study. Dr. Latib is Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, New York. Dr. Bapat is Chief of Cardiothoracic Surgery at the Minneapolis Heart Institute in Minneapolis, Minnesota.
“We’re beginning a new journey that we believe will open the door for the potential future treatment of patients with tricuspid valve regurgitation, who constitute a significant patient population suffering from heart valve disease today,” commented Dr. Latib in Medtronic’s announcement. “There has been much progress regarding transcatheter replacement of diseased aortic valves, but whether we can replace the tricuspid valve without open heart surgery represents a new frontier in cardiology.”
Dr. Bapat added, “The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to comorbidities. We are optimistic that these early learnings will help fuel additional clinical research and device innovation around this treatable disease.”
Medtronic noted that the Intrepid transcatheter valve is also being evaluated for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. Approval for this study was announced in September 2019.