Atlanta, Ga. (October 5, 2023) – Piedmont Heart Institute physicians successfully performed the first implantation in North America of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study.
Vinod Thourani, M.D., Bernie Marcus Chairman of the Department of Cardiovascular Surgery at Piedmont, and interventional cardiologist Pradeep K. Yadav, M.D., are local principal investigators on the study. They and cardiologists James P. Stewart, M.D., and Mani Vannan, M.D. performed the procedure in an 84-year-old woman with severe symptomatic tricuspid regurgitation (TR) through the right internal jugular vein. The TR level was reduced from severe to none and the patient was discharged from Piedmont Atlanta Hospital, where the procedure was performed, within two days after the procedure.
"This marks another major milestone in the management of TR,” Drs. Thourani, Yadav, Stewart and Vannan said in a joint statement. “This valve offers state-of-the-art features with very predictable, intuitive procedure via minimal invasive transcatheter approach. The patient was mobilizing within hours of the procedure and her recovery was stream-lined and expeditious."
"We are fortunate to collaborate with such skilled investigators. We are pleased with the preliminary outcomes and look forward to ongoing progress of the U.S. EFS," says Ron Davidson, Trisol's CEO.
Piedmont Atlanta is one of only four sites in the country where the study is being conducted.
Trisol patented valve features a distinctive design, that sets it apart from other tricuspid valves technologies. Trisol valve is comprised of a single leaflet, the leaflet is affixed by two commissures enabling it to function as a bi-leaflet valve. Notably, this novel design facilitates a slower closing of the leaflets, a feature intended to preserve the right ventricular function following the valve replacement. Trisol's valve employs axial anchoring, that reduces the risk of conductive issues.
Trisol aims to complete its EFS and initiate pivotal studies in 2024.