Adagio Medical treats 22 patients with vCLAS Ultra ablation system
ADGM•Adagio Medical reported that 22 patients at seven U.S. and Canadian centers were treated with its vCLAS Ultra system, including 19 study participants and three compassionate-use cases.
1. Treatments across seven centers
Adagio Medical reported 22 patients treated with its next-generation vCLAS Ultra ventricular ablation system at seven U.S. and Canadian centers. The treatments included 19 participants in the FULCRUM-VT IDE sub-study and three compassionate-use cases; the study continues through operational restructuring.
2. Regulatory and strategic updates
Physicians cited shorter ablation times and improved catheter performance compared with the first-generation system. FDA review continues for the first-generation vCLAS system’s premarket approval application, submitted in May 2026, while the board evaluates strategic alternatives to maximize shareholder value.
