A new mitral regurgitation (MR) therapy designed to treat patients with structural heart disease was shown to be a safer treatment option than other transcatheter mitral valve replacement (TMVR) in a presentation at this year’s Transcatheter Valve Therapies (TVT) conference in Chicago.
The valve, designed by 4C Medical Technologies in Brooklyn Park, Minnesota, is the first MR therapy that preserves the native mitral valve and left ventricle using a supra-annular, atrial-only fixation technology.
Its design also eliminates issues with some TMVR technologies that rely on placement and fixation in the native mitral annulus and left ventricle. Challenges associated with current TMVR approaches are related to the complexity of the mitral valve anatomy and the multitude of MR mechanisms.
"4C Medical's mitral valve is an innovative and simple solution for a very common problem, and its unique mechanism will allow treatment of many patients not suitable for current TMVR devices," said Philippe Généreux, MD, the co-director of the structural heart program and the Gagnon Cardiovascular Institute of Morristown Medical Center in New Jersey, in a statement. "30-day pre-clinical results are promising and demonstrate concept feasibility and safety, with no hemodynamic compromise, no thrombus, and mild-to-no MR as confirmed by echocardiography."
4C’s device preserves the native vale apparatus position in the left atrium, which helps avoids issues related to the complexity and dynamism of the mitral annulus.
"We are dedicated to innovating therapies for structural heart disease through clinical research in partnership with Key Opinion Leaders," said Robert Thatcher, CEO of 4C Medical Technologies, in a statement. "More than half of symptomatic MR patients are not candidates for surgery, and we are driven to develop new solutions that clinicians can use to improve the quality of life for these patients."