Adagio Medical receives FDA IDE approval to study next-gen vCLAS ventricular ablation system

Adagio Medical Holdings, Inc.

FDA grants IDE approval to expand FULCRUM-VT trial for next-gen vCLAS ULTA Ventricular Ablation System treating SMVT.
System achieves ~ -170°C for single-freeze lesions with >50% reduction in ablation time vs prior models.
Prospective, single-arm, multi-center sub-study of up to 55 patients for scar-mediated SMVT.
Next-gen vCLAS Ultra catheter designed for improved maneuverability, shorter freeze times, and scalability.
Goal is a single versatile catheter treating full VT range via endocardial approach on established ULTA platform.

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