Adagio Medical Completes Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Cryoablation for Ventricular Tachycardia

Wednesday, Oct 1, 2025 8:04 am ET1min read

Adagio Medical has completed enrollment for the FULCRUM-VT pivotal clinical trial evaluating its ultra-low temperature cryoablation technology for ventricular tachycardia treatment. The study, which has enrolled 208 patients across 20 centers in the US and Canada, will support a pre-market approval application for the vCLAS System. The technology has been granted Breakthrough Device Designation by the FDA and aims to address the limitations of current VT ablation technologies.

Adagio Medical Completes Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Cryoablation for Ventricular Tachycardia

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