Adagio Medical’s vCLAS System Used to Treat Premature Ventricular Contractions

Adagio Medical Holdings Inc. has completed 13 ventricular ablation procedures using its proprietary Ultra-Low Temperature Ablation (ULTA) technology under Expanded Access authorization from the U.S. Food and Drug Administration (FDA).

The procedures treated recurrent symptomatic ventricular tachycardia (VT) or premature ventricular contractions (PVC) in patients who had previously failed ablations with conventional and/or experimental solutions, including radiofrequency (RF), venous ethanol, and pulsed field ablation (PFA).

The Expanded Access Program (EAP)—also called “Compassionate Use”—is a potential pathway for patients with a serious or immediately life-threatening disease or condition to be treated with an investigational medical product outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA guidelines state that approval for Expanded Access may be appropriate when all the following apply:

• The patient has a serious or immediate life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible; and
• The potential patient benefit justifies any potential treatment risks.

“Our experience during the FULCRUM-VT pivotal study treating a wide range of patients with VTs due to structural heart disease demonstrated that the combination of catheter stability, lesion depth and the ability to safely navigate around sensitive structures with Adagio’s ULTA technology can be advantageous compared to other ablation technologies,” said Dr. Gregory Supple, director of Inpatient EP Services at the Hospital of University of Pennsylvania and a treating physician. “Through that experience we recognized that ULTA is a promising option when managing some of our most challenging patients who have failed other ablation approaches, including those with symptomatic PVCs. Similar to structural heart VTs, PVCs may have a deep site of origin close to coronary arteries or be associated with highly mobile structures. These locations make the VT more difficult to treat using RF or PFA, which have intrinsic limitations on lesion depth, present risk of coronary injury, or are highly sensitive to continuous contact between the catheter and tissue—the areas where ULTA may have a significant advantage. We are grateful to have had the opportunity to treat these patients with ULTA under the EAP.”

Physicians reported favorable acute procedural outcomes and effective workflow integration in the electrophysiology lab for these patients, which included both structural VTs and symptomatic PVCs. A structural VT is a rapid, often dangerous heart rhythm originating in the ventricles, occurring specifically in patients with underlying heart damage, such as scarring from a heart attack, cardiomyopathy, or heart failure. PVCs are extra, abnormal heartbeats that begin in the heart’s ventricles and can be highly symptomatic. While there is currently no U.S.-approved PVC ablation technology, PVC ablations represent an estimated 50% of the total addressable VT ablation market.

“We believe these compassionate use cases represent an important milestone for Adagio Medical and underscore the clinical need and differentiation of our proprietary ULTA platform. While initial clinical experience with ULTA in both the clinical studies and early compassionate use cases was limited to patients with structural heart disease, the recent inclusion of PVC patients under the EAP highlight the ability for ULTA to treat the full spectrum of ventricular arrhythmias, all through an endocardial approach,” Adagio Medical CEO Todd Usen stated. “We are thrilled that our technology can help patients who have no other option to treat their condition, and we are grateful to the physicians and patients who put their trust in our technology. We look forward to continuing to generate clinical evidence to support the advancement of our ULTA platform and sharing the results of our FULCRUM-VT pivotal trial at the Heart Rhythm Society scientific meeting in April.”

Adagio’s FULCRUM-VT IDE study, which fully enrolled in October 2025, is designed to support U.S. regulatory approval of Adagio’s vCLASTM Cryoablation System, which the company expects by year-end.

FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial that has enrolled 209 patients with structural heart disease including both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug-refractory VT in accordance with current treatment guidelines. Study results will be used to apply for FDA premarket approval (PMA) for Adagio’s vCLAS Cryoablation System.

Adagio’s vCLAS Cryoablation System is commercially available to treat monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States.

Adagio is a medical device company developing and commercializing products to treat cardiac arrhythmias using its proprietary, catheter-based Ultra-Low Temperature Ablation (ULTA, formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. 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 FULCRUM-VT U.S. Pivotal IDE Trial.