Adagio begins vCLAS Ultra heart study

• Adagio Medical treated the first patient in its vCLAS Ultra ventricular ablation study.
• The study evaluates safety and effectiveness of the device for sustained monomorphic ventricular tachycardia.
• The system is designed to support a future FDA PMA supplement submission.

Adagio Medical (NASDAQ:ADGM) announced the first patient treated in a clinical study evaluating its next-generation vCLAS Ultra Ultra-Low Temperature Ablation system for sustained monomorphic ventricular tachycardia.

The study is intended to support a Premarket Approval supplement to Adagio’s existing PMA for its first-generation vCLAS system, which is currently under review by the U.S. Food and Drug Administration.

“Adagio’s next generation vCLAS Ultra device handled with the familiarity of traditional catheters while efficiently reaching an especially challenging anatomic location in the ventricle,” said Dr. Roderick Tung, Director of Banner – University Medicine Heart Institute and Division Chief of Cardiology at the University of Arizona College of Medicine – Phoenix.

The first patient, who had non-ischemic cardiomyopathy and recurrent ventricular tachycardia after a previous catheter ablation, was treated using the vCLAS Ultra system at a challenging ventricular location beneath the mitral valve.

Adagio said the vCLAS Ultra system is designed to deliver single-freeze ablations at approximately -170°C, with preclinical data showing a potential 50%–75% reduction in ablation time compared with the first-generation system.

Adagio Medical develops catheter ablation technologies for cardiac arrhythmias, including ventricular tachycardia treatments using its Ultra-Low Temperature Ablation platform.

The company is conducting the supplemental study under an FDA-approved Investigational Device Exemption to evaluate the safety and effectiveness of the vCLAS Ultra system.