Adagio Medical submits PMA application to FDA for vCLAS VT ablation system
Adagio Medical announced FDA premarket approval submission for its vCLAS Ventricular Ablation System, supported by FULCRUM-VT pivotal trial data showing 97.4% acute success and 84.3% freedom from ICD. This marks the first PMA submission for a purpose-built VT ablation system in a $5.8B market, addressing a significant unmet medical need.
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