Adagio Medical’s vCLAS Cryoablation System Earns FDA Breakthrough Status
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a pioneer in catheter-based technologies for treating cardiac arrhythmias, has announced that its vCLAS™ Cryoablation System has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The designation applies specifically to the system’s use in treating drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with either ischemic or non-ischemic structural heart disease.
The vCLAS Cryoablation System, which is currently being evaluated in the FULCRUM-VT Investigational Device Exemption (IDE) study, is built around Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology. Designed to enhance both the safety and efficacy of VT ablations, the system aims to improve clinical outcomes for a population with few treatment options.
Ventricular tachycardia is a serious, life-threatening arrhythmia that originates in the heart’s ventricles—the lower chambers responsible for pumping blood. Sustained episodes of VT can lead to significant cardiovascular compromise and, in some cases, sudden cardiac death. The condition is especially challenging to treat in patients with structural heart disease, where scar tissue complicates ablation procedures and increases the risk of recurrence.
Breakthrough Device Program: Supporting Innovation
The FDA’s Breakthrough Device Program is intended to speed up the development and review of medical technologies that offer significant advantages over existing options in treating serious or life-threatening conditions. To receive this designation, a device must demonstrate the potential for more effective treatment or diagnosis and meet at least one additional criterion—such as representing a breakthrough technology, having no existing approved alternatives, offering a substantial benefit over current options, or addressing an unmet medical need.
As part of the program, Adagio will benefit from priority review and enhanced interaction with the FDA throughout the premarket approval process for the vCLAS Cryoablation System.
“This designation is a major milestone for Adagio and a validation of our vision to offer a transformative solution for ventricular tachycardia,” said Todd Usen, CEO of Adagio Medical. “We’re proud that the vCLAS System, powered by our Ultra-Low Temperature Cryoablation technology, is now the only system to receive Breakthrough status for endocardial treatment of both ischemic and non-ischemic VT. The FDA’s recognition, which builds in part on clinical data from our European CRYOCURE-VT study, brings us closer to delivering this innovation to U.S. patients and physicians.”
FULCRUM-VT: Advancing Toward Approval
The FULCRUM-VT trial (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multicenter, open-label, single-arm study. It is enrolling 206 patients with structural heart disease, including both ischemic and non-ischemic cardiomyopathy, who have not responded to drug therapy and are indicated for catheter ablation in line with current clinical guidelines.
The data from FULCRUM-VT will be pivotal in Adagio’s submission for FDA premarket approval. If successful, it could establish the vCLAS Cryoablation System as the broadest endocardial ablation solution for scar-mediated VT in the industry.
A Global Perspective
While still under investigational use in the United States, the vCLAS Cryoablation System is already commercially available in parts of Europe and other select global markets for the treatment of monomorphic VT. The system is CE-marked and has shown promising results in early clinical use, bolstering confidence in its performance and potential impact.
About Adagio Medical
Adagio Medical is a medical device company focused on developing next-generation solutions for the treatment of cardiac arrhythmias using its proprietary Ultra-Low Temperature Cryoablation (ULTC) technology. Unlike traditional cryoablation, ULTC is designed to create deeper, more durable lesions that span the full thickness of both healthy and diseased cardiac tissue. The company’s lead product, the vCLAS Cryoablation System, is purpose-built for the treatment of ventricular tachycardia and is currently undergoing clinical evaluation in the United States under the FULCRUM-VT IDE study.
With a growing footprint in both U.S. and international markets, Adagio is committed to transforming arrhythmia care through innovation, clinical evidence, and collaboration with the global cardiology community.
