Study Begins for Adagio Medical’s Ventricular Tachycardia Cryoablation System

Adagio Medical Inc. has been granted U.S. Food and Drug Administration (FDA) approval for the FULCRUM-VT Investigational Device Exemption study of its VT Cryoablation System. The first commercial procedures using the CE-Marked system have already taken place. 

Ventricular tachycardia (VT) procedures remain highly technical and time consuming, with a non-trivial rate of serious complications, and are predominantly performed in high-volume academic centers. The Adagio Medical VT Cryoablation System with the vCLAS cryoablation¹ catheter is based on the company’s proprietary ultra-low cryoablation technology (ULTC) and was designed specifically to address the challenges of VT ablations, with features and performance making it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.
 
“Since the recent CE Mark approval, we have done a number of Adagio’s ablation procedures on patients with different types of VT and challenging PVCs and our initial experience is very convincing,” said Professor Dr. Roland Tilz, director of the Department of Rhythmology at the University Clinic Schleswig-Holstein, who performed the first commercial cases. “The size and depth of the lesions achievable using ULTC technology and catheter design makes it a game-changer in time-consuming large area ablations. It is also a very promising approach for targeting deep mid-myocardial circuits, which represent a major challenge for the conventional radiofrequency (RF) ablations. If safety and effectiveness of the technology demonstrated in recently published Cryocure-VT study² is confirmed in the post-market setting, that will change the risk-benefit calculation when selecting candidates for the ablation and allow us to treat more patients earlier in their disease process.^3,4 And, in our case, to cut the wait time for patients already suffering from debilitating symptoms associated with drug-refractory ventricular tachycardias.”
 
In the United States, the vCLAS technology is being evaluated in the FULCRUM-VT Early Feasibility (EFS IDE) study, which has completed enrollment. Preliminary results and the Cryocure-VT dataset support FDA approval for the conversion of the FULCRUM-VT study to a pivotal phase. The expanded, single-arm study will enroll 206 patients with monomorphic VT due to structural heart disease of both ischemic and non-ischemic origin at 20 U.S. and Canadian centers. Co-principal study investigators are Dr. Roderick Tung, chief, Division of Cardiology at Banner University Medical Center in Phoenix (Ariz.) and Dr. Atul Verma, director, Division of Cardiology at McGill University Health Centre. “Both of us have extensive experience performing VT ablations using ULTC technology in the earlier studies,” Dr. Verma stated, “and recognize the value it brings to the procedure. There is a pent-up demand for innovation in the VT ablation space, so we expect a lot of interest in study participation from the top academic electrophysiology programs in the U.S.”
 
“We greatly appreciate the partnership from the electrophysiology community in the U.S. and EU as we expand our proprietary ULTC platform to the benefit of the sizeable, yet underserved population of patients with drug-refractory VTs,” Aagio Medical President/CEO Olav Bergheim added. “We believe we have a strong momentum in both commercial launch and clinical trials program, and look forward to sharing our progress on both fronts.”
 
Adagio Medical Inc. is a privately held company located in Laguna Hills, Calif., developing cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia.

References
¹ The Adagio Medical, Inc. VT Cryoablation System (Catheter and Console) is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissues that drive and maintain these arrhythmias. The vCLAS™ Cryoablation Catheter, a component of the Adagio Medical, Inc. VT Cryoablation System is intended to create transmural linear and focal lesions to cardiac structures within the endocardium of the ventricles with cryoablation. Adagio Medical, Inc. PM-006 Rev. E
² Verma A, Essebag V, Neuzil P, Dyrda K, et al. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Europace (2024) 26, euae076. https://doi.org/10.1093/europace/euae076
³ Sultan A, Futyma P, Metzner A, Anic A, et al. Management of ventricular tachycardias: insights on centre settings, procedural workflow, endpoints, and implementation of guidelines—results from an EHRA survey. Europace (2024) 26, 1–10. https://doi.org/10.1093/europace/euae030
⁴ Giandalini G, Liang JJ, Marchlinski FE, et al. Ventricular Tachycardia Ablation: Past, Present, and Future Perspectives. J Am Coll Cardiol EP 2019;5:1363–83. https://doi.org/10.1016/j.jacep.2019.09.015