Adagio Medical Holdings, Inc. (ADGM) has received Investigational Device Exemption (IDE) approval to expand its FULCRUM-VT trial and evaluate its next-generation vCLAS Ultra-Low Temperature Ablation System for treating sustained monomorphic ventricular tachycardia.
Ventricular tachycardia is one of the most challenging heart rhythm disorders to treat, often requiring deep and durable lesions that current ablation tools struggle to achieve. Adagio's next-generation vCLAS system is designed to address these limitations by delivering ultra-cold temperatures- around -170 °C -to create effective lesions more efficiently.
The IDE expansion allows Adagio to launch a clinical sub-study evaluating the new vCLAS Ultra catheter, which builds on the company's existing ULTA platform. Pre-clinical models have shown that the system can reduce ablation time by more than 50% using single-freeze applications. Investigators expect improvements in catheter maneuverability, freeze times, and overall workflow efficiency.
The sub-study will enroll up to 55 patients with scar-mediated SMVT across multiple centers. It is intended to generate additional safety and effectiveness data in the same patient population being evaluated in the pivotal phase of the FULCRUM-VT trial.
Adagio executives said the IDE approval marks an important milestone in advancing a technology that could broaden access to VT ablation. The company believes the vCLAS Ultra catheter has the potential to become a scalable, endocardial-only solution capable of treating a wide range of VT substrates.
ADGM has traded between $1.17 and $1.25 over the past year. The stock closed Tuesday's trading at $1.18, down 2.32%. In pre-market trading the stock is at $1.25, up 6%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.