Adagio Medical treats first patient in vCLAS Ultra IDE study

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has treated the first patient in its investigational device exemption (IDE) study evaluating the next-generation vCLAS Ultra Ultra-Low Temperature Ablation system for sustained monomorphic ventricular tachycardia (SMVT), according to a company press release.

The procedure was performed by Dr. Roderick Tung at Banner – University Medical Center Phoenix. The patient had non-ischemic cardiomyopathy and recurrent ventricular tachycardia following a prior catheter ablation. The target site was a thick anatomic area beneath the mitral valve, an area the company described as presenting challenges in catheter reach and lesion depth.

"The catheter reached a sub-valvular substrate just under the mitral valve annulus with ease from both transseptal and retrograde approaches," said Dr. Tung. "We successfully treated the arrhythmogenic substrate with remarkably short ablation times, aided by the catheter's large surface area and deep ablation footprint."

The IDE study is designed to support a Premarket Approval (PMA) supplement to the company's existing PMA application for its first-generation vCLAS system, which is currently under FDA review. Enrollment is underway across multiple sites.

The vCLAS Ultra system is designed to deliver single-freeze ablations at approximately -170°C. Pre-clinical data indicate a potential 50–75% reduction in ablation time compared to the first-generation system, which the company said could reduce overall procedure time by 30 minutes or more.

Adagio submitted results from its FULCRUM-VT pivotal study to the FDA in May 2026 to support the PMA application for the first-generation vCLAS system. The FULCRUM-VT trial enrolled 209 patients with structural heart disease. The vCLAS system is CE Marked and commercially available in Europe and select other markets, but remains limited to investigational use in the United States.

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