Medtronic (NYSE:MDT) today released 30-day results from the pilot study of its Intrepid transcatheter mitral valve replacement system, touting procedural success and reductions in mitral regurgitation from the 1st 50 consecutive patients in the trial.
Data was presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published in the Journal of the American College of Cardiology, the Fridley, Minn.-based company said.
The pilot study aimed to evaluate the safety and performance of the Intrepid system in patients with severe, symptomatic mitral valve regurgitation.
“These early outcomes with the Intrepid TMVR System are encouraging as we investigate a minimally-invasive alternative to surgical mitral valve replacement. 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. Paul Sorajja of the Minneapolis Heart Institute Foundation, who presented the study, said in a press release.
Results at 30 days indicated that the system was successfully implanted in 98% of patients with notable reductions in mitral regurgitation with patients experiencing none, trace or mild mitral regurgitation at 30-days compared to moderate or severe at baseline.
Patients in the study also reported symptomatic improvements with 79% classified as New York Heart Association class I or II at their last follow-up.
The Intrepid system features self-expanding, dual-stent technology and a replacement tissue heart valve to allow for catheter-based implantation. The valve is compressed inside a hollow delivery catheter inserted between the ribs to enter the heart and is expanded directly into the malfunctioning mitral valve, the company said. The outer stent is designed to attach and conform to the native valve without sutures or anchors while the inner stent houses the valve, made from bovine tissue.
“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,” Intrepid pilot study principal investigator Dr. Vinayak Bapat of Columbia University Medical Center/New York-Presbyterian Hospital said in a press release.
The company announced the launch of the FDA-cleared Apollo pivotal trial of the Intrepid TMVR system late last month.