Adagio Wins FDA IDE to Expand Study of Next-Gen Ventricular Ablation Catheter

Adagio Medical Holdings has been granted investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to expand its FULCRUM-VT trial of the next-gen vCLAS Ultra-Low Temperature Ablation (ULTA) ventricular ablation system to treat sustained monomorphic ventricular tachycardia (SMVT).

The IDE expansion lets Adagio begin a clinical sub-study to evaluate the next-gen vCLAS system, including the next-gen vCLAS Ultra catheter. The vCLAS ULTA catheter achieves ablation temperatures of about -170°C for efficient, single-freeze applications demonstrated to product effective lesions with over 50% reduction in ablation time as shown in preclinical 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,” said Alex Babkin, chief technology officer of Adagio Medical. “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 prospective, single-arm, multi-center, pre-market, clinical supplemental study aims to generate safety and efficacy data for use of the vCLAS system to treat scar-mediated SMVT in ischemic and non-ischemic patients, which is the same population treated in the pivotal phase of the IDE study. The IDE expansion nod is for 55 proposed 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,” said Todd Usen, CEO of Adagio Medical. “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.”

The vCLAS ventricular ablation system received FDA breakthrough device status in April 2025.