Novel Device for Treating Mitral Regurgitation

Project Summary Four million people in the U.S. are expected to be diagnosed with mitral valve regurgitation by 2030. The large majority of these patients are denied surgery and consequently faces high mortality rates. In order to address this need, the field of transcatheter heart valve therapies has produced a wide array of device concepts for treating mitral regurgitation over the past 20 years. Only one of these, edge-to-edge leaflet clipping, has reached clinical use, but with mediocre results. Link Medical has invented a new approach for treating mitral regurgitation that is not derivative of any previous technologies. In patients with functional mitral regurgitation, the valve apparatus has been pulled out of its normal configuration and consequently the valve cannot close properly. The hypothesis of this project is that the impaired valve closure is due to specific pairs of mitral chords being held apart from each other. Link is developing a catheter technology that restores the valve chord positions by placing a simple constraining band around them. This concept is intended to be simpler, more robust and more effective than any existing technology. In Phase I, the details of the procedure and device design will be optimized through bench testing; then a series of acute in vivo studies will be performed to demonstrate the feasibility of the procedure.