Adagio Submits PMA Application for Ventricular Ablation System to FDA

May 21, 2026 — Adagio Medical Holdings, a provider of catheter ablation technologies for treating cardiac arrhythmias, has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration for the vCLAS Ventricular Ablation System for treating drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.

The PMA submission is supported by the FULCRUM-VT pivotal IDE trial, a single-arm study of 209 patients across 20 electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug (AAD) use. vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.

Todd Usen, CEO of Adagio Medical said, “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. Our endocardial-only approach has the potential to democratize VT ablation for electrophysiologists and offers physicians a purpose-built tool capable of treating every eligible VT patient — ischemic and non-ischemic alike — without compromise. 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.”