Adagio Medical Receives IDE Approval to Investigate Next-Gen vCLAS Ventricular Ablation System

The U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand Adagio Medical Holdings Inc.’s FULCRUM-VT trial, advancing the evaluation of its next-generation vCLAS ULTA Ventricular Ablation System as a treatment for sustained monomorphic ventricular tachycardia (SMVT).

“Ventricular tachycardia remains one of the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,” said William Stevenson, M.D., professor of Medicine and principal site investigator at Vanderbilt University Medical Center. “We have been impressed with the safety and clinical results of the initial ULTA system for treating VT in patients with ischemic and nonischemic cardiomyopathies. We are looking forward to evaluating the next generation of the system, which we anticipate will have improved catheter maneuverability and allow shorter freeze times, both factors that should reduce procedure times.”

The expansion approval allows Adagio Medical to begin a clinical sub-study to evaluate its next-generation vCLAS Ventricular Ablation System, including the next-generation vCLAS Ultra catheter, which incorporates the company’s all-endocardial Ultra-Low Temperature Ablation (ULTA) technology. Adagio’s vCLAS Ultra catheter achieves ablation temperatures of approximately -170°C, enabling highly efficient, single-freeze applications that are clinically proven to produce effective lesions with greater than 50% reduction in ablation time as demonstrated in pre-clinical models.

“The vCLAS Ultra, which was designed to improve energy delivery, navigation, lesion control, and overall procedural workflow efficiency, reflects our team’s ability to expeditiously translate feedback from our physician partners into meaningful technological advancement. In parallel, the design incorporates improvements in manufacturability, supporting scalability and reducing overall system cost,” Adagio Medical Chief Technology Officer Alex Babkin stated. “Importantly, this advancement positions us to potentially offer the market a single, versatile catheter capable of treating the full range of VT substrates, all through an endocardial approach, with our clinically established ULTA platform technology. This IDE approval is an important step toward clinically validating what we believe could be a paradigm-shifting technological solution for VT.”

The sub-study is a prospective, single-arm, multi-center, pre-market, clinical supplemental trial designed to provide safety and efficacy data for Adagio’s next-generation vCLAS Ventricular Ablation System in treating scar-mediated SMVT in ischemic and non-ischemic patients—the same population treated in the pivotal IDE study phase. The IDE expansion is approved for 55 total patients in a staged sub-study design.

“We are building on a strong and growing body of clinical evidence supporting the effectiveness of our ULTA technology, which has already demonstrated the ability to create deep, effective lesions through a fully endocardial approach,” Adagio Medical CEO Todd Usen stated. “IDE approval for this study expansion marks an important milestone as we continue to advance our vCLAS Ultra catheter, which we built to enable broader adoption across all electrophysiology practices. Our goal is to translate this proven technology into a highly scalable solution that can democratize the treatment of VT and become the go-to ablation catheter for treating the large, underserved population of patients who suffer from this disease. On behalf of the entire Adagio team, we would like to thank the FDA for their collaboration and partnership.”

Adagio Medical is a medical device company developing and commercializing products for treating cardiac arrhythmias with its novel, proprietary, catheter-based Ultra-Low Temperature Ablation (ULTA, formerly known as ULTC) technology. ULTA creates large, durable lesions extending through the depth of both diseased and healthy cardiac tissue in an endocardial-only approach. The company is currently focused on treating ventricular arrhythmias with its purpose-built vCLAS Cryoablation System, which is CE Marked and is currently under evaluation in the company’s FULCRUM-VT U.S. pivotal IDE trial.