Adagio Medical (Nasdaq:ADGM) today announced the successful treatment of the first patient with its next-generation vCLAS technology.
The treatment took place under the FDA’s Expanded Access authorization. It utilized the company’s Ultra Ultra-Low Temperature Ablation (ULTA) system.
Laguna Hills, California-based Adagio said the patient presented with non-ischemic cardiomyopathy and a recent history of failed radiofrequency (RF) and coronary venous alcohol ablations to address their ventricular tachycardia (VT). The successful treatment took place at the Hospital of University of Pennsylvania (HUP). Dr. Gregory Supple performed the procedure.
Adagio said the case marks a significant step forward in its mission to transform the treatment of VT.
vCLAS Ultra represents the next generation of Adagio’s proprietary ULTA technology. It builds on the existing vCLAS system, which Adagio submitted to the FDA in May.
The platform delivers single-freeze ablations at approximately -170°C. Pre-clinical data demonstrates a potential 50-75% reduction in ablation time. It also delivered procedures up to 30 minutes shorter compared to the first-generation system.
In April, the FDA granted investigational device exemption (IDE) to expand the company’s FULCRUM-VT trial to evaluate the next-generation Ultra system for treating Sustained Monomorphic Ventricular Tachycardia (SMVT).
Commentary from Adagio leadership and doctors
CEO Todd Usen said:
“Treating the first patient with our next-generation vCLAS Ultra system is not only a proud milestone for the entire Adagio team, but also for our physician partners and the patients they treat and reflects our continued commitment to advancing our ULTA technology platform as the only purpose-built solution for VT. Building on the compelling pivotal data on ULTA presented at Heart Rhythm 2026 — including only 2.4% major adverse events and six-month results of 84% freedom from implantable cardioverter defibrillator shock and 78% relative reduction in amiodarone use across the broadest patient population in any VT ablation study — the next generation vCLAS Ultra System is designed to significantly reduce ablation time and further improve the overall procedural workflow for physicians. With FDA approval of our first-generation ULTA system expected in the coming months, this milestone underscores the depth of our pipeline and reaffirms our confidence in ULTA as a transformative platform to address the entire spectrum of patients eligible for ablation to treat their VT.”
Dr. Supple said:
“Adagio’s next generation vCLAS Ultra system represents a meaningful advancement in VT ablation by combining the proven Ultra-Low Temperature Ablation — or ULTA — energy platform with a faster, more maneuverable catheter, giving electrophysiologists a promising solution for the complex, deep-substrate cases that have long defied conventional energy sources. The proven safety profile of ULTA has allowed physicians to confidently ablate near critical structures — an increasingly important consideration in modern VT practice. This was particularly relevant in this case where the VT originated in the periaortic region, characterized by thick myocardium and proximity to the coronary arteries, a situation that presents a common challenge for other approved and experimental ablation technologies. Using the vCLAS Ultra system, we were able to successfully treat the patient, who remains free from VT recurrence approximately two months post-procedure. The catheter flexibility and single-freeze design dramatically reduced procedure time compared to the first generation vCLAS device while still delivering the durable, transmural lesions that define this technology. Most importantly, vCLAS Ultra provides us with the potential for a single catheter capable of addressing the full range of substrates we encounter in real-world practice.”
