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Adagio Medical

Laguna Hills, California, United Statesadagiomedical.com ↗

Ownership: Private
Development stage: Commercial

Overview

Adagio’s vCLAS™ cryoablation system is under evaluation in the FULCRUM-VT pivotal IDE study for drug-refractory, recurrent monomorphic VT. The company has received FDA Breakthrough Device designation for this system. Early European studies demonstrated a 97.1% acute elimination of clinical VT cases and 81% of patients were free from defibrillator shocks at six months post-procedure. U.S. pivotal enrollment surpassed 40% as of early 2025, with full enrollment expected by late 2025.

Therapeutic areas: Cardiovascular
Modalities: DeviceCryoablation system (Ultra-Low Temperature Cryoablation)
Industry: Surgical Medical Devices

Drug pipeline

1 asset

vCLAS Cryoablation System

Phase 3

Indications: Ventricular tachycardia

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