India, April 8 -- Adagio Medical Holdings, Inc. (ADGM) has received Investigational Device Exemption (IDE) approval to expand its FULCRUM-VT trial and evaluate its next-generation vCLAS Ultra-Low Temperature Ablation System for treating sustained monomorphic ventricular tachycardia.
Ventricular tachycardia is one of the most challenging heart rhythm disorders to treat, often requiring deep and durable lesions that current ablation tools struggle to achieve. Adagio's next-generation vCLAS system is designed to address these limitations by delivering ultra-cold temperatures- around -170 degC -to create effective lesions more efficiently.
The IDE expansion allows Adagio to launch a clinical sub-study evaluating the new vCLAS Ultra catheter, ...