Adagio Medical Holdings (NASDAQ:ADGM) announced on April 8, 2026, that the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval to expand its FULCRUM-VT clinical trial.
The expansion will evaluate the safety and effectiveness of the company’s next-generation vCLAS™ Ultra-Low Temperature Ablation (ULTA) system for treating sustained monomorphic ventricular tachycardia (SMVT).
The approval allows Adagio to initiate a clinical sub-study involving 55 patients across multiple centers.
The study targets patients with both ischemic and non-ischemic cardiomyopathies, focusing on the system's ability to treat scar-mediated SMVT through a fully endocardial approach.
The centerpiece of the expansion is the new vCLAS Ultra catheter.
Built on Adagio’s established ULTA platform, the device achieves extreme temperatures of approximately -170°C.
In pre-clinical models, this next-generation technology demonstrated the ability to create deep, effective lesions with more than a 50% reduction in ablation time compared to earlier iterations.
Beyond clinical performance, Adagio management emphasized that the vCLAS Ultra was designed with scalability in mind.
The new catheter incorporates manufacturing improvements intended to reduce system costs and facilitate broader adoption across electrophysiology practices.