MAY 22·BioSpaceMed
Adagio Medical Submits Premarket Approval Application to FDA for vCLAS® Ventricular Ablation System for the Treatment of Ventricular Tachycardia
Adagio Medical has submitted a Premarket Approval (PMA) application to the FDA for its vCLAS® Ventricular Ablation System, designed to treat drug-refractory, recurrent ventricular tachycardia. This submission is supported by positive data from the FULCRUM-VT pivotal trial, which showed high acute clinical success and significant improvements in patient outcomes. The company believes this endocardial-only approach could democratize VT ablation and address a major unmet need in treating both ischemic and non-ischemic cardiomyopathy.