Adagio Medical Provides Business Update: 22 Patients Treated with Next-Generation vCLAS™ Ultra System as FULCRUM-VT IDE Sub-Study Advances
Key Highlights
- ➤22 patients treated with vCLAS Ultra across seven U.S. and Canadian centers
- ➤FULCRUM-VT sub-study enrolled 19 patients; three additional compassionate-use cases
- ➤Ablation times reduced by more than 60% versus Adagio’s first-generation system
- ➤Strategic alternatives review progresses without a definitive completion timetable
- ➤FDA discussions continue on PMA application submitted for first-generation vCLAS in May 2026
Expert Statements
Vidal Essebag, MD, PhD, Director of Cardiac Electrophysiology, McGill University Health Centre
“Our experience with Adagio’s next-generation Ultra platform has been extremely encouraging. Having performed eight procedures, more than any other center worldwide to date, we have seen meaningful advancements in procedural workflow, catheter performance, and the freeze profile, allowing for a more efficient and streamlined approach to treating complex ventricular arrhythmias compared to the first-generation ULTA product.”
Vidal Essebag, MD, PhD, Director of Cardiac Electrophysiology, McGill University Health Centre
“From our earliest experience, we recognized the potential of ultra-low temperature ablation to address some of the most challenging aspects of VT treatment. We believe these improvements in the Ultra catheter, combined with the ability to create deep, durable lesions across a broad ablation footprint, represent an important step forward in advancing treatment options for patients with ventricular tachycardia.”
Todd Usen, CEO of Adagio Medical
“Our team remains committed to optimizing our operations while prioritizing our focus on providing ULTA as a solution for the broadest population of patients suffering from VT. With 22 patients now treated with vCLAS Ultra, we believe the early clinical experience is validating what we designed this catheter to do, as physicians are seeing ablation times reduced by more than 60% compared to our first-generation system, with our smaller, more flexible next-generation catheter.”
Todd Usen, CEO of Adagio Medical
“Throughout our operational restructuring and strategic review, we have continued to prioritize the FULCRUM-VT sub-study as we believe that this is the most important thing we can do for patients and for our shareholders. At the same time, our Board’s review of strategic alternatives is progressing, and we remain focused on realizing the full value of our ULTA platform.”
Adagio Medical Provides Business Update: 22 Patients Treated with Next-Generation vCLAS™ Ultra System as FULCRUM-VT IDE Sub-Study Advances
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today provided a business update highlighting continued execution of its FULCRUM-VT IDE study and FULCRUM-VT IDE sub-study, as well as progress of its previously announced review of strategic alternatives.
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