Medtronic (NYSE: MDT) shared positive data from a study of its Intrepid transcatheter mitral valve replacement (TMVR).
The medtech giant presented one-year results from the Intrepid early feasibility study at TCT 2023. It simultaneously published the data in JACC: Cardiovascular Intervention.
Medtronic says the study demonstrated the early benefits of the Intrepid TMVR-transfemoral system, maintained up to one year. The system demonstrated near complete and durable elimination of mitral regurgitation (MR) with a 93.3% survival rate.
The investigative Medtronic TMVR system uses transfemoral access as an alternative to surgical mitral valve replacement. It treats MR in patients unsuitable for surgery or transcatheter edge-to-edge repair (TEER). Medtronic evaluated 33 non-surgery candidates with moderate-severe or severe symptomatic MR in the prospective, multi-center, non-randomized, single-arm study.
Key outcomes included low mortality rates at 6.7% and zero strokes, Medtronic said. The company also reported a low re-intervention rate (3%) along with the near complete elimination of MR.
Dr. Firas Zahr or Oregon Health & Science University cited “high rates of device and procedural success” in the study. Zahr said it demonstrates the potential of the novel technology for treating MR for those unable to undergo surgery.
“We are pleased to see these positive results from the 30-day study carry out to one year,” Zahr said.