CARDIOVASCULAR RESEARCH TECHNOLOGY (CRT) MEETING 2020 BEST INNOVATIONS COMPETITION
CRT 2020’s Innovations Hub culminated with the Best Innovations Competition on Monday. Steven J. Yakubov, MD, FACC, MSCAI, of OhioHealth Riverside Methodist Hospital in Columbus, Ohio, won for his presentation, “Foldax Tria: First in Human Implant of a Totally Synthetic Polymeric Aortic Valve.”
The “truly next-generation” valve, as Yakubov called it, so far has been used in first-in-human surgical aortic valve replacement (SAVR) procedures, but Yakubov said it is under development for use in transcatheter aortic valve replacement (TAVR) as well.
The TAVR design has a self-expanding nitinol frame with supra-annual leaflets, maintains coronary access, and has a 13-mm polymer sealing skirt. Yakubov said the new polymer technology used in the valve is “engineered to potentially last a patient’s lifetime.” It allows for a larger effective orifice area for better hemodynamics and has a lower profile than existing TAVR valves.
The early feasibility study for the SAVR valve is estimated to finish enrollment in March 2020, with a target to begin the investigational device exemption application process by late 2020. Yakubov added that the first-in-human studies for the TAVR valve are tentatively planned for 2021.
“Steve, great job, and congratulations to you and the team,” said Mark A. Turco, MD, medical director aortic and peripheral vascular for Medtronic, in announcing Yakubov as the winner.
