Adagio Medical Holdings, Inc., a leading developer of catheter ablation technologies for cardiac arrhythmias, today announced preliminary acute safety and efficacy results from its FULCRUM-VT study, evaluating Ultralow Temperature Cryoablation (ULTC) for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT) in patients with both ischemic and nonischemic cardiomyopathy. The data were presented by Dr. Travis Richardson, Assistant Professor of Medicine in Clinical Cardiac Electrophysiology at Vanderbilt University Medical Center, during a Late Breaking Clinical Trials Session at the 20th Annual International Symposium on Ventricular Arrhythmias held in Philadelphia on October 10, 2025.
Study Overview
A total of 207 patients underwent VT ablation using Adagio’s ULTC system across 19 sites in the U.S. and Canada. The study population included patients with both ischemic cardiomyopathy (ICM) and nonischemic cardiomyopathy (NICM), with a mean left ventricular ejection fraction (LVEF) of 35 ± 10%. Approximately 33% of patients had NICM, and 75% had a history of congestive heart failure.
The mean procedure duration was 206 ± 68 minutes, reflecting efficient workflow despite the complexity of VT ablation. Acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was achieved in 97.4% of patients, with all clinically relevant VTs eliminated in 96.7% of patients as assessed by post-ablation programmed electrical stimulation.
Key safety outcomes included a 2.5% rate of major adverse events, including four peri-procedural deaths (1.9%), one of which (0.5%) was adjudicated as definitely related to the investigational device by an independent clinical events committee.
A detailed presentation, including supporting figures and data, has been filed as a Current Report on Form 8-K and is publicly available on the SEC website at www.sec.gov.
Clinical Significance
Dr. Richardson noted, “The patient profile in FULCRUM-VT is representative of what we see in real-world practice. The ULTC system’s ability to create deep, titratable endocardial lesions without irrigation and without concerns regarding catheter stability makes it a promising tool for a broad patient population. These characteristics, combined with the study’s inclusive eligibility criteria, allowed for rapid enrollment across multiple centers.”
He continued, “Importantly, the study included a significant number of patients with nonischemic cardiomyopathy, whose ventricular tachycardia is often more challenging to treat due to deeper myocardial substrates. Despite this, the acute effectiveness across the entire study population was excellent. The favorable safety profile, coupled with the high success rate in eliminating clinically relevant VTs, is particularly encouraging. Ventricular tachycardia remains largely undertreated, in part because available ablation tools can be technically challenging. ULTC has the potential to address these unmet needs.”
The six-month primary efficacy endpoint for the FULCRUM-VT trial is anticipated to be presented at Heart Rhythm 2026, providing additional insight into the longer-term effectiveness of the technology.
Study Design
The FULCRUM-VT study is a prospective, multi-center trial designed to evaluate the acute safety and effectiveness of ULTC in patients with scar-related VT who are refractory to antiarrhythmic drug therapy and have a left ventricular ejection fraction greater than 20%.
Beyond acute results, the study will assess long-term outcomes, including procedural durability and effectiveness across various myocardial substrates, providing comprehensive data for clinicians seeking to optimize VT ablation strategies.
Technology Highlights
Adagio’s ULTC system employs ultralow temperature cryoablation, a novel approach capable of producing deep, precise, and titratable lesions in the myocardium without the need for irrigation or concerns about catheter stability during complex VT procedures. The system is designed to streamline ablation of both ischemic and nonischemic VT, expanding treatment options for patients with challenging arrhythmias.
Dr. Richardson emphasized that ULTC’s design allows clinicians to treat a broad spectrum of VT patients safely and effectively, potentially transforming the treatment landscape for this high-risk population.
Company Leadership Perspective
Todd Usen, CEO of Adagio Medical, said, “We are very pleased with the preliminary acute results from the FULCRUM-VT study, which highlight the potential of our proprietary ULTC technology to transform VT treatment. These results demonstrate strong acute effectiveness and a favorable safety profile, which we believe will benefit patients and clinicians alike.”
He continued, “We extend our gratitude to the investigators, research coordinators, and, most importantly, the patients who participated in this study. Their commitment is helping us develop a purpose-built solution for ventricular tachycardia, advancing the field of cardiac electrophysiology and improving outcomes for this underserved patient population. Presenting these findings at the VT Symposium’s Late Breaking Session underscores the significance of this work to the cardiovascular community.”
Next Steps
The company plans to continue monitoring long-term outcomes and evaluate effectiveness in different patient subgroups, including variations in myocardial scarring and arrhythmia substrate. The upcoming six-month data will provide additional evidence of ULTC’s ability to produce durable results in a real-world clinical setting.
With its novel cryoablation technology, broad applicability, and encouraging acute results, ULTC has the potential to redefine VT treatment, offering physicians a reliable, effective, and safe option for a patient population with significant unmet needs.
