Jerusalem, 22 January, 2026 (TPS-IL) — Israeli medical device startup Trisol Medical reported positive results from an FDA-approved U.S. Early Feasibility Study of its transcatheter tricuspid valve replacement system for patients with severe to torrential tricuspid regurgitation.
The Yokneam-based company said 22 high-risk patients were treated at leading U.S. medical centers, showing a favorable safety profile and significant functional improvements. At 30 days and up to 12 months, patients demonstrated reduced valve leakage, improved quality of life, better heart failure status, and gains in right ventricular function. Fewer than 5 percent required a permanent pacemaker.
Trisol has completed enrollment using a trans-jugular approach and is advancing enrollment with a newly developed transfemoral delivery system.