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Adagio Medical seeks FDA PMA for ventricular ablation system
Adagio Medical has submitted a premarket approval (PMA) application to the FDA for its vCLAS ventricular ablation system. The application draws on data from the FULCRUM-VT pivotal IDE trial, which enrolled 209 patients across 20 centres. The vCLAS system reportedly achieved similar clinical outcomes in both ischaemic and non-ischaemic cardiomyopathy patient groups. Credit: NMK-Studio / Shutterstock.com. Adagio Medical has submitted a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its vCLAS ventricular ablation system. The company is seeking authorisation to market the system for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in…
Adagio Medical has submitted a premarket approval (PMA) application to the FDA for its vCLAS ventricular ablation system.
Source: Medical Device Network