LAGUNA HILLS, Calif., March 19, 2026
Adagio Medical Holdings, Inc. announced successful outcomes from Expanded Access Program (EAP) cases using its vCLAS™ Cryoablation System, demonstrating promising results in patients suffering from ventricular tachycardia (VT) and premature ventricular contractions (PVC) who had failed conventional therapies. The procedures utilized the company’s proprietary Ultra-Low Temperature Ablation (ULTA) technology, highlighting its potential as a next-generation solution for complex cardiac arrhythmias.
Expanded Access Program Enables Treatment of High-Risk Patients
The Expanded Access Program, also known as compassionate use, allowed physicians to treat patients with serious or life-threatening cardiac conditions who lacked alternative therapeutic options or were unable to enroll in clinical trials. Under this pathway, 13 ventricular ablation procedures were successfully completed, targeting patients with recurrent VT or symptomatic PVC who had previously failed radiofrequency (RF), pulsed field ablation (PFA), and other modalities.
This milestone underscores the critical role of regulatory pathways like EAP in enabling early clinical use of investigational technologies. Importantly, these cases demonstrated that ULTA technology can address deeply located arrhythmia sources and anatomically challenging regions, which are often difficult to treat using existing ablation methods.
Ultra-Low Temperature Technology Demonstrates Clinical Advantage
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Adagio’s ULTA platform is designed to create large, durable lesions across both diseased and healthy cardiac tissue, offering advantages over traditional ablation technologies. Physicians reported favorable acute procedural outcomes, improved catheter stability, and enhanced workflow integration in electrophysiology labs. Notably, ULTA technology showed effectiveness in treating complex PVC cases, a segment that currently lacks FDA-approved ablation solutions in the United States.
PVCs, which represent abnormal heartbeats originating in the ventricles, account for nearly 50% of the total addressable VT ablation market, indicating a substantial unmet clinical need. The ability of ULTA to treat both structural ventricular tachycardia and PVCs through an endocardial approach highlights its potential to become a comprehensive solution for ventricular arrhythmias.
Pathway Toward Regulatory Approval and Market Expansion
The encouraging results from these compassionate use cases complement findings from the FULCRUM-VT pivotal IDE study, which has fully enrolled over 200 patients and is designed to support U.S. FDA premarket approval (PMA) of the vCLAS™ system. Adagio expects regulatory progress by late 2026, positioning the technology for broader clinical adoption.
Currently, the vCLAS™ system is commercially available in Europe for certain indications but remains investigational in the United States, reflecting ongoing regulatory evaluation. The company continues to generate clinical evidence to validate the safety, efficacy, and reproducibility of ULTA technology, reinforcing its commitment to advancing innovative device-based therapies under stringent regulatory frameworks.
Advancing Innovation in Cardiac Arrhythmia Treatment
The successful use of Adagio’s vCLAS™ system in Expanded Access cases represents a significant step forward in cardiac electrophysiology, particularly for patients with limited treatment options. By combining innovative cryoablation technology with regulatory pathways such as EAP, the company is addressing critical gaps in arrhythmia management while advancing toward full regulatory approval.
This development highlights the growing importance of MedTech innovation in improving patient outcomes, especially in complex cardiovascular conditions where traditional therapies fall short. As clinical evidence continues to evolve, ULTA technology may play a key role in transforming the standard of care for ventricular arrhythmias.
Source: Adagio Medical press release
