Adagio Medical's Ultra-Low Temperature Cryoablation Shows 97% Acute Success Rate in Pivotal Ventricular Tachycardia Trial
Key Insights
Adagio Medical's FULCRUM-VT pivotal study demonstrated 97.4% acute clinical success in treating sustained monomorphic ventricular tachycardia (search) using proprietary ultra-low temperature cryoablation (search) technology.
The study enrolled 207 patients with both ischemic and non-ischemic cardiomyopathy (search) across 19 sites, completing enrollment in just 11 months despite historically slow VT ablation study recruitment.
Major adverse events occurred in 2.5% of patients, with one device-related death (0.5%), while 96.7% of patients had all clinically-relevant ventricular tachycardias eliminated.
Adagio Medical Holdings (search) has announced compelling preliminary results from its FULCRUM-VT pivotal study, demonstrating a 97.4% acute clinical success rate for its proprietary ultra-low temperature cryoablation (search) (ULTC) technology in treating sustained monomorphic ventricular tachycardia (search). The data, presented at the 20th Annual International Symposium on Ventricular Arrhythmias in Philadelphia, marks a significant milestone for the first VT-specific ablation technology to complete enrollment in a pivotal FDA Investigational Device Exemption study in the United States.
Breakthrough Clinical Results
The FULCRUM-VT study enrolled 207 patients with both ischemic and non-ischemic cardiomyopathy (search) across 19 sites in the United States and Canada. The patient population was representative of real-world practice, with a mean left ventricular ejection fraction of 35±10%, 33% having non-ischemic cardiomyopathy, and 75% presenting with congestive heart failure (search).
Acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was achieved in 97.4% of patients. Post-ablation programmed electrical stimulation demonstrated elimination of all clinically-relevant ventricular tachycardias in 96.7% of patients tested. The mean procedure duration was 206±68 minutes.
"The patient profile in FULCRUM-VT is representative of what we see in real-world practice," said Dr. Travis Richardson, Assistant Professor of Medicine at Vanderbilt University Medical Center, who presented the data. "The ability of Adagio's ULTC system to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability make it a promising tool for a broad patient population."
Safety Profile and Clinical Significance
The safety analysis revealed a 2.5% rate of major adverse events, including four peri-procedural deaths (1.9%), of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device.
Dr. Richardson emphasized the clinical significance of these results, noting that "FULCRUM-VT not only included patients with ischemic myopathy, but also a large number with nonischemic disease, whose VT is often more difficult to treat due to deep substrate. Despite this, the acute effectiveness across the study population was excellent."
Rapid Enrollment Reflects Market Need
The study's completion of enrollment in just 11 months represents a remarkable achievement in the VT ablation field, where studies have historically been "notoriously difficult and slow to enroll," according to Dr. Rod Tung, Chief of the Division of Cardiology at Banner University Medical Center (search) and study co-principal investigator.
"The fact that the FULCRUM-VT pivotal study completed enrollment in only 11 months speaks volumes to both the market need for a purpose-built VT ablation technology and the positive early experiences with Adagio's ULTC at the top VT ablation programs that participated in the study," Dr. Tung explained.
Technology Platform and Regulatory Path
Adagio's vCLAS Cryoablation System (search) is built on the company's proprietary ULTC technology platform, which has been granted Breakthrough Device Designation by the FDA. The technology is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue.
"To date, our options for VT ablation have been limited to catheters and energy sources originally developed to treat atrial arrhythmias," noted Dr. Tung, highlighting the significance of a purpose-built VT ablation solution.
The vCLAS System is currently commercially available for the treatment of monomorphic ventricular tachycardia (search) in Europe and select other geographies but remains limited to investigational use in the United States pending FDA approval.
Future Outlook
Todd Usen, Chief Executive Officer of Adagio Medical, expressed gratitude to the study investigators and participants, stating, "We are excited for the potential to bring our ULTC technology to the underserved population of VT patients and we anticipate completion of the PMA process for the vCLAS System by year-end 2026, consistent with previous guidance."
The company plans to present the six-month primary efficacy endpoint results at the Heart Rhythm 2026 conference. The FULCRUM-VT study's primary efficacy endpoint is six-month freedom from recurrent monomorphic ventricular tachycardia (search) in the absence of new or increased dose of pre-ablation antiarrhythmic drugs (search) for VT management.
Dr. Richardson concluded, "VT is a largely undertreated condition, partially because the available treatment tools make ablation procedures challenging, and I have hope that ULTC will help to change that."