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Adagio Medical's FULCRUM-VT Trial Receives FDA's Investigational Device Exemption Approval To Evaluate Safety, Effectiveness Of vCLAS Ultra-Low Temperature Ablation Ventricular Ablation System To Treat Sustained Monomorphic Ventricular Tachycardia

Benzinga·04/08/2026 12:08:18
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Adagio Medical Holdings, Inc. (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company's FULCRUM-VT trial to evaluate the safety and effectiveness of the Company's next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).