Adagio Medical (Nasdaq:ADGM) announced today that it submitted its premarket approval (PMA) application to the FDA for its vCLAS system.
The company submitted its vCLAS ventricular ablation system for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.
Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of VT ablations, comprising part of the Adagio VT cryoablation system. The system’s features make it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.
vCLAS picked up FDA breakthrough device designation in April 2025. The company supported its PMA submission with outcomes from the FULCRUM-VT pivotal IDE trial. Findings from 209 patients included 97.4% acute clinical success with compelling six-month outcomes.
CEO Todd Usen said the company believes its endocardial-only approach could potentially democratize VT ablation and offer a purpose-built tool capable of treating every eligible VT patient.
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 use, and consistent results across the broadest patient population ever studied in a VT ablation trial. We look forward to working closely with the FDA through the review process and are energized by the possibility of bringing this technology to a broad population of patients suffering from VT.”
