Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter

Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial.

FULCRUM-VT evaluates the company’s vCLAS cryoablation technology for treating cardiovascular disease. Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system. The system’s features make it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.

vCLAS picked up FDA breakthrough device designation in April 2025 and said a few months later that it completed enrollment for FULCRUM-VT.

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