Adagio Medical Receives FDA IDE Approval for Next-Generation vCLAS™ Ventricular Ablation System

Adagio Medical Holdings, Inc. announced on April 8, 2026, that it has received Investigational Device Exemption (IDE) approval from the FDA. This approval allows for the expansion of the FULCRUM-VT trial to evaluate the safety and effectiveness of their next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System. This system is designed for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT). The new system, including the vCLAS Ultra catheter, is built upon the company's existing ULTA technology and aims to improve catheter maneuverability, reduce ablation time, and enhance overall procedural efficiency. The sub-study will enroll 55 patients with scar-mediated SMVT. The company believes this advancement could offer a significant improvement in treating VT, a challenging cardiac arrhythmia, through an endocardial approach.