other material
confidence high
sentiment positive
materiality 0.75
Adagio Medical reports 97.4% acute effectiveness in FULCRUM-VT pivotal study for VT ablation
Adagio Medical Holdings, Inc.
- 207 patients enrolled at 19 U.S./Canadian sites; 97.4% acute clinical success (non-inducibility of target VTs).
- Major adverse event rate 2.5%; four peri-procedural deaths (1.9%), one device-related (0.5%).
- Study included ICM and NICM patients (mean LVEF 35%, 75% with CHF); mean procedure time 206 min.
- ULTC system uses -196°C cryoablation without irrigation; 6-month primary endpoint expected at HRS 2026.
- Next-generation 8.5Fr catheter with shorter ablations in development.