Direct Medical Flow has announced a program to develop its transcatheter mitral valve at the 2nd Annual Zurich Heart Team Mitral Valve meeting.
The announcement took the form of a preclinical case presentation of the Transcatheter mitral valve.
The transcatheter mitral valve has been developed from the conformable, repositionable and retrievable Direct Flow Medical transcatheter aortic valve. The aortic valve has been successfully implanted over 2,500 times, according to a company release. It has exhibited low rates of paravalvular leak, pacemaker implant and mortality in published clinical results.
The mitral valve is designed to feature a low atrial profile, low ventricular projection and conformable sealing and fixation rings for the complex mitral annulus.
Azeem Latib, San Raffaele Hospital, Milan, presented preclinical results demonstrating transapical implant feasibility. Latib notes, “The valve’s unique conformable ring design is ideally suited for the complex shape of the mitral annulus.” He says, “Implanting this valve was similar to implanting the Direct Flow Medical transcatheter aortic valve, as I had total procedural control and performed a full haemodynamic assessment prior to deployment.”
Dan Lemaitre, Direct Flow Medical president and chief executive, states, “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 fourth quarter 2016 first-in-man implant objective.”