Adagio Medical (Nasdaq:ADGM) today announced new six-month results from its FULCRUM-VT clinical trial evaluating its ablation technology.
FULCRUM-VT evaluates the company’s vCLAS cryoablation technology for treating cardiovascular disease. Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system. The system’s features make it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.
vCLAS picked up FDA breakthrough device designation in April 2025 and said a few months later that it completed enrollment for FULCRUM-VT. The FDA granted investigational device exemption (IDE) to expand the trial earlier this month.
Adagio shared its findings at Heart Rhythm Society (HRS) 2026 in Chicago. It plans to use outcomes to support FDA premarket approval for vCLAS.
Results included 98% non-inducibility of targeted VT at the end of the procedure, plus a promising safety profile with 2.4% protocol-defined major adverse events. Investigators also observed 84% freedom from implantable cardioverter defibrillator (ICD) shock at six months.
Adagio also reported 59% freedom from any VT recurrence at six months and equivalent results for ischemic and non-ischemic cardiomyopathy patients. Findings also included a more than 80% reduction in the number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation. Nearly three quarters (72%) discontinued or reduced their dose of amiodarone at six months. Meanwhile, the study saw a low (1.9%) rate of 30-day VT-related hospital readmission.
Commentary from Adagio officials and investigators
Todd Usen, CEO of Adagio Medical, said:
“These pivotal results represent a noteworthy milestone for Adagio and validate the potential for our ULTA technology to address a significant unmet need for treating one of the most complex and challenging arrhythmias. In the United States alone, ventricular arrhythmias account for approximately 300,000 sudden cardiac deaths each year; VT is difficult to treat, and procedures performed with current devices can be overly complex, with sub-optimal outcomes in both effectiveness and safety. However, our FULCRUM-VT study demonstrated strong clinical effectiveness with a highly favorable safety profile with our vCLAS ablation catheter. Importantly, we achieved these results without compromising catheter stability and without the added risks of irrigation or nitroglycerin, thereby supporting the potential for a more streamlined workflow and reproducible approach to VT ablation. We believe ULTA has the potential to become a foundational ablation technology for treating the ventricle and we look forward to serving the large, underserved population of patients suffering from VT.”
Dr. Matthew Hakimi, medical director at Adagio Medical, said:
“The FULCRUM-VT results are a significant clinical achievement and compare favorably against published RF (radiofrequency) benchmarks and the emerging PFA (pulsed field ablation) data for VT. It is the only pivotal IDE trial to show consistent endocardial-only outcomes across both ischemic and non-ischemic cardiomyopathy — and the combination of catheter stability, titratable lesion depth, and safe navigation near vulnerable structures such as the coronary arteries positions ULTA to address arguably the broadest spectrum of VT encountered in practice. FULCRUM-VT sets a new benchmark for VT ablation, and I want to commend the many physicians and their clinical coordinators for their diligent work in evaluating this novel technology.”
Dr. Atul Verma, director, Division of Cardiology, McGill University Health Centre in Montreal, said:
“FULCRUM-VT represents a seminal step forward in advancing ventricular tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an endocardial-only approach using Adagio’s purpose-built ventricular ablation technology. The results of the trial, which were consistent with earlier ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, including reductions in both ICD shocks and the use of toxic antiarrhythmic medication – outcomes that matter most to patients and physicians managing this complex disease. Additionally, the ability to ablate these already compromised patients without ever needing to irrigate or use nitroglycerin, both of which carry added risk, is a real benefit of ULTA. The FULCRUM-VT results are quite encouraging for the broad use of this technology as a long-term solution for patients suffering from VT.”
