Transcatheter heart valve specialist, Direct Flow Medical, Inc., has confirmed the existence of a mitral valve development program, based on the innovative design features that have proven so successful in its established aortic valve offering.
Direct Flow Medical develops and commercializes transcatheter heart valve therapy products to treat structural heart disease. The company formally announced its transcatheter mitral valve development program at the 2nd Annual Zurich Heart Team Mitral Valve meeting by featuring the Direct Flow Medical Transcatheter Mitral Valve in a preclinical case presentation.
The Direct Flow Medical Transcatheter Mitral Valve is built upon the proven conformable, repositionable, and retrievable Direct Flow Medical Transcatheter Aortic Valve with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality. The mitral-specific valve design features low atrial profile, low ventricular projection, and unique conformable sealing and fixation rings for the complex mitral annulus.
Dr. Azeem Latib, San Raffaele Hospital, Milan, presented preclinical results demonstrating transapical implant feasibility. Dr. Latib noted, “The valve’s unique conformable ring design is ideally suited for the complex shape of the mitral annulus.” He said, “Implanting this valve was similar to implanting the Direct Flow Medical Transcatheter Aortic Valve as I had total procedural control and performed a full hemodynamic assessment prior to deployment.”
Dan Lemaitre, Direct Flow Medical President and CEO, stated, “Today’s case is an important milestone in developing and commercializing a mitral-specific transcatheter valve built upon our universal valve design platform.” He further commented, “Direct Flow Medical was initially founded as a transcatheter mitral valve company. Much of our preclinical testing is completed and we are hopeful that we will achieve a Q4 2016 first-in-man implant objective.”
Source: Business Wire