LAGUNA HILLS, Calif. — September 16, 2026

Adagio Medical Holdings, Inc. announced the first patient enrollment in its FDA-approved Investigational Device Exemption (IDE) study evaluating the next-generation vCLAS™ Ultra Ventricular Ablation System for sustained monomorphic ventricular tachycardia (SMVT). The study is designed to support a potential PMA supplement to the company’s existing application for its first-generation vCLAS system, which is currently under FDA review. The first patient, treated at Banner – University Medical Center Phoenix, had non-ischemic cardiomyopathy and recurrent VT following a previous catheter ablation. The procedure targeted a challenging thick anatomical region beneath the mitral valve, providing an early clinical example of the system’s intended application across complex ventricular arrhythmia cases.

vCLAS Ultra Targets Faster VT Ablation

The vCLAS Ultra system is designed to deliver single-freeze ultra-low-temperature ablations at approximately -170°C while improving catheter maneuverability and procedural efficiency. Adagio says preclinical testing demonstrated a potential 50% to 75% reduction in ablation time, which could translate into overall procedure-time reductions of 30 minutes or more compared with the first-generation system. The catheter is designed with a larger ablation surface and deep lesion footprint to address ventricular substrates through an endocardial approach. During the first procedure, physicians were able to reach the sub-valvular substrate beneath the mitral valve annulus using both transseptal and retrograde approaches. These design features are intended to preserve the broad lesion-creation capabilities of the ULTA platform while making the workflow more efficient for physicians treating ventricular tachycardia.

IDE Study Expands Clinical Evaluation of ULTA

The vCLAS Ultra IDE program is intended to evaluate the safety and effectiveness of the next-generation system in patients with sustained monomorphic ventricular tachycardia. The study builds on Adagio’s broader clinical development of its proprietary Ultra-Low Temperature Ablation (ULTA) technology, which is designed to create large, titratable lesions extending through diseased and healthy cardiac tissue. The company previously completed enrollment of 209 patients in the FULCRUM-VT pivotal study, which evaluated the first-generation vCLAS system in patients with structural heart disease and drug-refractory VT. The six-month primary chronic effectiveness endpoint was freedom from sustained monomorphic VT lasting more than 30 seconds or VT requiring appropriate ICD therapy, without escalation of previously failed antiarrhythmic medication. Adagio submitted the FULCRUM-VT results to the FDA in May 2026 to support its PMA application for vCLAS.

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Adagio Builds Next-Generation VT Ablation Platform

The vCLAS Ultra program represents Adagio’s effort to expand the clinical and commercial potential of its ULTA technology for ventricular arrhythmia treatment. The company is developing the next-generation catheter with a smaller, more flexible form factor and improved maneuverability while maintaining the platform’s all-endocardial approach. Adagio believes these characteristics could support treatment across a broad spectrum of VT patients and challenging anatomical substrates. The first-generation vCLAS system is already CE Marked and commercially available in Europe and select other markets, while remaining investigational in the United States. With enrollment underway across multiple sites, the vCLAS Ultra IDE study is now providing clinical data intended to support the next stage of the company’s U.S. regulatory strategy. Continued evaluation will focus on demonstrating whether the redesigned catheter can combine ULTA’s established lesion capabilities with a faster and more efficient VT ablation workflow.

Source:Adagio Medical, press release