California medtech company Direct Flow Medical notched some major milestones today, announcing a European regulatory win and completed enrollment in a U.S. feasibility trial for its transcatheter aortic valve implantation systems.
Direct Flow landed CE Mark approval in the European Union for its 29 mm TAVI system, which it calls "the 1st fully repositionable" device of its kind, allowing unlimited repositioning even after full deployment.
The TAVI system’s ability to change position so late in the implantation process helps physicians prevent valve leakage by allowing complete hemodynamic assessment to determine whether the valve can be better situated. The larger-sized annulus also extends TAVI technology to a broader population.
"Until now, patients with large annulus sizes who could not undergo surgical valve replacement had limited options, as other commercially available valves often leave significant aortic regurgitation at larger sizes and are not repositionable or retrievable," president & CEO Bernard Lyons said in prepared remarks. "With the addition of the 29mm valve to our portfolio, we can now greatly improve outcomes for this group of patients, as well."
The company also completed enrollment in a feasibility study of its TAVI system, the 1st anti-leak valve studied in a U.S. clinical trial, Direct Flow said. The SALUS trial is a non-randomized, multi-center study conducted under investigational device exemption from the FDA, initial enrollment for which began in September.
Direct Flow hopes to proceed to a pivotal trial some time this year.
"This is an exciting time for Direct Flow Medical as we are the 1st company to achieve FDA approval to evaluate a transcatheter aortic heart valve that can solve important issues such as aortic regurgitation," chief medical officer Dr. Charles Davidson said in prepared remarks. "This new technology enables physicians to assess patient outcomes before final valve implantation, so they have the ability to further optimize valve placement through repositioning, if necessary."
Direct Flow has some serious competition in the TAVI arena and is approaching the market as a relative new-comer, but the company says it can use its greenness to its advantage. Building on experiences with older TAVI systems, Direct Flow designed its device to address complaints surgeons have had with rival device makers’ products.
Direct Flow’s implant features a metal-free frame and a low-profile, flexible delivery system designed to eliminate aortic regurgitation, or valve leakage that has been associated with long-term mortality.
Direct Flow and its TAVI technology will have to face down some of the medical device industry’s largest players, including Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Edwards Lifesciences (NYSE:EW) and St. Jude Medical (NYSE:STJ), in order to gain share in the TAVI arena.