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 patients with either ischaemic or non-ischaemic structural heart disease.
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The application draws on data from the Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia (FULCRUM-VT) pivotal IDE trial, which enrolled 209 patients across 20 electrophysiology centres.
This study showed a 97.4% acute clinical success rate, and 84.3% of patients experienced freedom from implantable cardioverter defibrillator (ICD) shock at six months.
Major adverse events occurred in 2.4% of cases while use of anti-arrhythmic drugs decreased or was eliminated in 78% of patients.
The vCLAS system reportedly achieved similar clinical outcomes in both ischaemic and non-ischaemic cardiomyopathy patient groups.
Adagio Medical CEO Todd Usen said: “The submission of our PMA application is a defining moment for Adagio Medical and, more importantly, for the hundreds of thousands of patients suffering from ventricular tachycardia who currently have no purpose-built solution.
“We believe FULCRUM-VT demonstrated that Adagio’s proprietary ULTA is not just a different approach to VT ablation – it is a fundamentally better solution, which achieved compelling outcomes across the metrics that matter most to physicians and patients: safety, freedom from ICD shock, reduction in AAD [antiarrhythmic drug] use, and consistent results across the broadest patient population ever studied in a VT ablation trial.”
The FULCRUM-VT study was conducted as an open-label, multi-centre, single-arm, prospective trial.
All 209 enrolled patients had structural heart disease of either ischaemic or non-ischaemic cardiomyopathy and met treatment guidelines for catheter ablation of drug-refractory VT.
The vCLAS cryoablation system is available in Europe and some other markets for treatment of monomorphic VT, but its use remains limited to investigational purposes in the US pending regulatory review.
In October 2025, Adagio Medical secured $19m upfront through a private placement, aimed at advancing its ultra-low temperature cryoablation (ULTC) technology for ventricular tachycardia (VT) treatment.
