Novel Self-closing 12F Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Transcatheter Edge-to-Edge Repair (TEER) Technique Via Femoral Vein Access.

Project Summary The MEDFREE® Valve Repair System will innovatively improve upon the current market leading MitraClip device, while leveraging and building on the proven Transcatheter Edge-to-Edge Repair technique. We aim to address this vastly unmet percutaneous structural heart market by delivering a simpler, easier-to-use device in a smaller 12F catheter system that can be used by a single operator. MEDFREE has already completed preclinical GLP studies in porcine model (Cohort A: n=2, 30 days; Cohort B: n=5, 140 days) with outstanding results. MRI and Durability (fatigue) studies were also completed with outstanding results. We are now seeking funds via NIH Commercialization Readiness Program, in preparation for EFS/FIH clinical studies.