Adagio Medical treats first patient with next-generation vCLAS Ultra ULTA system under FDA expanded access
ADGM•First patient treated under FDA Expanded Access
Adagio Medical treated the first patient under FDA Expanded Access using its next-generation vCLAS Ultra ultra-low temperature ablation system for ventricular tachycardia.
The procedure succeeded in a patient with prior failed ablation attempts, supporting the device’s potential in hard-to-treat cases near sensitive anatomy.
Clinical and regulatory updates for the ULTA platform
Pre-clinical work indicates the single-freeze design could shorten procedures, a change that could improve lab throughput and adoption if replicated clinically.
Clinical results were already presented at Heart Rhythm 2026 for the ULTA platform, showing a favorable safety profile and reduced arrhythmia-related interventions.
FDA cleared an IDE expansion of the FULCRUM-VT pivotal trial to evaluate the next-generation system, ahead of an expected decision on the first-generation system in coming months.
