Trisol Begins Early Feasibility Study of Transcatheter Tricuspid Valve in the United States

August 29, 2023—Trisol Medical Ltd., which is based in Yokneam, Israel, recently announced the first two implantations in the United States of the Trisol transcatheter tricuspid valve replacement device as part of an FDA-approved early feasibility study (EFS), which is led by Principal Investigator Isaac George, MD. The company advised that it aims to complete its EFS and initiate pivotal studies in 2024.

The first procedures were conducted by the heart teams at the Piedmont Heart Institute in Atlanta, Georgia, and the University of Virginia Health System in Charlottesville, Virginia.

The first case was performed at Piedmont Heart Institute by Pradeep Yadav, MD, James Stewart, MD, and Vinod Thourani, MD. The patient was a woman in her mid 80s with severe symptomatic tricuspid regurgitation (TR). The device was delivered through the right internal jugular vein. The patient’s TR level was reduced from severe to none and she was discharged from the hospital within 2 days after the procedure.

In the company’s press release, the Piedmont physicians commented, “This marks a major milestone in the management of TR. We were able to abolish the patient’s valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass. The patient was mobilizing within hours of the procedure and her recovery was streamlined and expeditious.”

The second case was conducted by Scott Lim, MD, of the University of Virginia Health System. The patient was a woman in her mid 70s with severe symptomatic TR. The TR level was reduced from severe to trace. The patient was discharged from the hospital within 2 days after the procedure.

“The patient had a gratifying result with essentially elimination of her tricuspid regurgitation, and rapid recovery, along with significant and rapid improvement in her symptoms,” commented Dr. Lim in Trisol’s press release. “We look forward to further investigation of the Trisol valve.”

The company stated that the Trisol valve has been implanted in ten patients. Five of these implantations were performed as part of the Israeli pilot study led by Principal Investigator Ran Kornowski, MD. Currently, the longest follow-up period exceeds 2 years.

The Trisol valve is comprised of a single leaflet that is affixed by two commissures, enabling it to function as a bileaflet valve. This design is intended to facilitate a slower closing of the leaflets to preserve the right ventricular function after the valve replacement. The Trisol valve employs axial anchoring that reduces the risk of conductive issues, noted the company.