Early Outcomes Presented for Medtronic's Intrepid TMVR System
November 1, 2017—Medtronic announced the presentation of data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. Data from the first 50 consecutive patients enrolled in the Intrepid Pilot Study demonstrated successful device implantation and a substantial reduction in mitral regurgitation at 30 days.
The data were presented by Paul Sorajja, MD, as a first report investigation at TCT 2017, the Transcatheter Cardiovascular Therapeutics scientific symposium being held October 30 to November 2 in Denver, Colorado. The study was simultaneously published online by Vinayak Bapat, MD, et al in Journal of the American College of Cardiology.
The Intrepid Pilot Study was designed to evaluate valve safety and performance of the Intrepid TMVR system at sites in the United States, Europe, and Australia.
According to the company, the initial 30-day outcomes showed that the Intrepid TMVR system was successfully implanted in 98% of patients. Early results also demonstrated reductions in mitral regurgitation in patients with either none/trace or mild mitral regurgitation at 30 days compared to moderate to severe at baseline. Patients also continued to have symptomatic improvements, with 79% of patients classified as New York Heart Association class I or class II at their last follow-up.
Dr. Sorajja, who is Headrick Family Chair, Valve Science Center at the Minneapolis Heart Institute Foundation in Minneapolis, Minnesota, commented in Medtronic's announcement, “These early outcomes with the Intrepid TMVR system are encouraging as we investigate a minimally invasive alternative to surgical mitral valve replacement.” He continued, “The Intrepid TMVR system is easy to implant in the challenging mitral anatomy due to its conformable, dual-stent design, and the device corrects the underlying mitral regurgitation in a significant majority of patients.”
Dr. Bapat, the pilot study's Principal Investigator, added, “It is an exciting time for mitral valve replacement therapy as demonstrated by the promise of such truly innovative technologies that can positively impact patients suffering from mitral valve disease. We look forward to further investigation of the Intrepid TMVR system with the landmark APOLLO pivotal trial, which just got underway.” Dr. Bapat is a cardiothoracic surgeon at Columbia University Medical Center/NewYork-Presbyterian Hospital in New York, New York.
On October 23, Medtronic announced the first patient implantation of the Intrepid TMVR system in the pivotal APOLLO trial, which is designed to evaluate the safety and efficacy of the device in up to 1,200 patients with severe, symptomatic mitral valve regurgitation.
The Intrepid TMVR system integrates self-expanding, dual-stent technology with a tissue valve to facilitate catheter-based implantation without the need for open heart surgery. The device is available for investigational use only and it is not approved for use outside of clinical studies, advised the company.