Announcement • Apr 27
Adagio Medical Holdings, Inc. Announces Positive Pivotal Results for vCLAS Ventricular Ablation System Adagio Medical Holdings, Inc. reported six month results from its FULCRUM-VT Investigational Device Exemption clinical trial, which will be used to support the Company’s application for Food and Drug Administration Premarket Approval of the vCLAS Ventricular Ablation System. Key findings included: 98% non-inducibility of targeted ventricular tachycardias at end of procedure, promising safety profile with 2.4% protocol-defined Major Adverse Events, 84% freedom from implantable cardioverter defibrillator shock at 6 months, 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug escalation), equivalent results for ischemic and non-ischemic cardiomyopathy patients, over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation, 72% of patients discontinued or reduced dose of amiodarone at 6 months, low 1.9% rate of 30-day VT-related hospital readmission. FULCRUM-VT is a prospective, multi-center, open-label, single-arm IDE study investigating the vCLAS Cryoablation System at 20 centers in the United States and Canada. The study enrolled 209 patients with structural heart disease, whether ischemic or non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. FULCRUM-VT is the first and only fully enrolled IDE clinical trial for VT to include patients with both ICM and NICM disease and includes one of the most challenging patient cohorts ever treated in a VT ablation trial. Ablation targets for VT associated with NICM disease tend to be in deeper myocardial substrate and therefore are more difficult to treat using an endocardial approach with currently approved technology. These two patient cohorts had equivalent outcomes, as measured by both freedom from VT recurrence and freedom from ICD shock, representing what the Company believes to be the first and only catheter ablation technology to show equivalent effectiveness in these distinct and historically challenging VT substrates. FULCRUM-VT included patients with both ICM and NICM disease (LVEF=35+/-10%, 34% NICM, 79% with congestive heart failure). Freedom from device intervention (ATP or shock) at 6 months was 61% for ICM and 63% for NICM; freedom from ICD shock at 6 months was 84% for ICM and 85% for NICM. Mean ablation time per patient was 54 minutes. Mean lesions per patient: 11.5 ± 6. Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths, of which only two (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device. All safety and VT recurrence data were adjudicated by independent Event Committees. The study also demonstrated clinically meaningful de-escalation of the use of amiodarone, an important clinical goal, with a substantial proportion of patients reducing or discontinuing amiodarone therapy post-procedure. The results also showed a significant reduction in hospital readmission rates compared to those historically reported in the VT ablation literature, underscoring the potential clinical and economic impact of the therapy. FULCRUM-VT 6-month primary chronic effectiveness was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in the absence of new or increase in antiarrhythmic drug dose beyond previously failed ablation. The results of the study, which have not yet been reviewed or approved by the FDA, will be used to apply for U.S. Food and Drug Administration premarket approval for Adagio’s vCLAS Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT. Adagio’s vCLAS Cryoablation System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States. Announcement • Apr 21
Adagio Medical Holdings, Inc., Annual General Meeting, Jun 16, 2026 Adagio Medical Holdings, Inc., Annual General Meeting, Jun 16, 2026. Announcement • Apr 09
Adagio Medical Holdings, Inc. Receives FDA IDE Approval To Investigate Next-Generation VCLAS Ventricular Ablation System Adagio Medical Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT). The approval for IDE expansion enables Adagio to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System including the next generation vCLAS Ultra catheter, which has been built on the clinical foundation established by the Company’s all-endocardial ULTA technology. Adagio’s vCLAS Ultra catheter achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce effective lesions with greater than 50% reduction in ablation time as demonstrated in pre-clinical models. The sub-study is a prospective, single-arm, multi-center, pre-market, clinical supplemental study designed to provide safety and efficacy data regarding the use of Adagio’s next generation vCLAS Ventricular Ablation System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients, which is the same population treated in the pivotal phase of the IDE study. The IDE expansion approval is for a total of 55 proposed patients in a staged sub-study design. 
