Adagio Medical reports 13 expanded access ventricular ablations using ULTA vCLAS system

Reuters03-19

Adagio Medical reports 13 expanded access ventricular ablations using ULTA vCLAS system

Adagio reported completion of 13 ventricular ablation procedures performed under the FDA Expanded Access Program using its vCLAS system and Ultra-Low Temperature Ablation technology in patients with recurrent ventricular tachycardia or premature ventricular contractions.
Physicians involved said the patients had previously failed ablation attempts using modalities including radiofrequency, venous ethanol, and pulsed field ablation.
Adagio said its FULCRUM-VT IDE pivotal study fully enrolled in October 2025 and is intended to support U.S. regulatory approval of the vCLAS Cryoablation System, which it expects by year-end 2026.
The company said results from the FULCRUM-VT pivotal trial will be presented in the future at the Heart Rhythm Society scientific meeting in April.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adagio Medical Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260319236268) on March 19, 2026, and is solely responsible for the information contained therein.

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