Direct Flow Medical said yesterday it premiered its transcatheter mitral valve, developed as part of its TMV development program. The debut was made at the 2nd annual Zurich Heart Team Mitral Valve meeting.
The valve is designed to be repositionable and retrievable, and is built upon Direct Flow’s transcatheter aortic valve, the Santa Rosa, Calif.-based company said.
“The valve’s unique conformable ring design is ideally suited for the complex shape of the mitral annulus. 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,” Dr. Azeem Latib of Milan, Italy’s San Raffaele Hospital said in prepared remarks.
The new device’s mitral-specific valve design features a low atrial profile, low ventricular projection and sealing and fixation rings for the complex mitral annulus, the company said.
“Today’s case is an important milestone in developing and commercializing a mitral-specific transcatheter valve built upon our universal valve design platform. 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 1st-in-man implant objective,” CEO Dan Lemaitre said in a prepared statement.
In October, Direct Flow touted 1-year data from a post-market study of its transcatheter aortic valve implantation system that showed a 95% rate of mild or no paravalvular regurgitation.
The low rate of paravalvular leaks is of primary importance to the TAVI market, Direct Flow CEO Dan LeMaitre told MassDevice.com, as the procedures become more common and the technology moves from only extreme risk patients to those with surgical options.
LeMaitre joined Direct Flow from Medtronic (NYSE:MDT), where he landed after leading CoreValve to an $800 million acquisition by the medical giant.