Direct Flow Medical, a medical device company developing and commercializing transcatheter heart valve therapy products to treat structural heart disease, announced its transcatheter mitral valve development program today 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."
Direct Flow Medical, Inc. is a privately-held medical device company developing and commercializing novel transcatheter heart valve therapy products to treat structural heart disease.
The company is sponsoring the SALUS Pivotal Trial in the U.S. to investigate the Direct Flow Medical Transcatheter Aortic Valve System for treatment of high and extreme risk severe symptomatic aortic stenosis. The system is commercially available in Europe for treatment of patients with aortic stenosis who are at extreme surgical risk.