FDA grants breakthrough device designation to Medtronic TTVR system, approves early feasibility study

Medtronic announced Wednesday, Sept. 9, that its Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) system has received the FDA’s breakthrough device designation—but the news didn’t end there. The FDA also approved an early feasibility study focused on the Intrepid TTVR system in patients with severe tricuspid regurgitation.

More than two million patients in the U.S. alone experience tricuspid regurgitation, according to Medtronic. The company views this condition as a “large, unmet clinical need.”

“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,” Azeem Latib, MD, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City and the study’s co-principal investigator, said in a prepared statement. “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.”

“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 co-morbidities," Vinayak Bapat, MD, chief of cardiothoracic surgery at the Minneapolis Heart Institute and the study’s other co-principal investigator, said in the same statement. “We are optimistic that these early learnings will help fuel additional clinical research and device innovation around this treatable disease.”