LAGUNA HILLS, Calif. — Adagio Medical has treated the first patient with its next-generation vCLAS Ultra system, an experimental catheter ablation technology designed to shorten procedures for patients with ventricular tachycardia.
The procedure was performed under the U.S. Food and Drug Administration’s Expanded Access program at the Hospital of the University of Pennsylvania.
The patient had non-ischemic cardiomyopathy and a recent history of unsuccessful radiofrequency and coronary venous alcohol ablation procedures for ventricular tachycardia.
Gregory Supple, M.D., Director of Inpatient Electrophysiology Services at the hospital, performed the procedure. Supple is also an investigator in Adagio’s FULCRUM-VT pivotal clinical trial.
Adagio said the patient remained free of ventricular tachycardia recurrence approximately two months after treatment.
“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,” Supple said.
He said the technology could help physicians treat complex arrhythmias arising from deep heart tissue or areas near critical structures.
In this case, the ventricular tachycardia originated near the aorta, an area characterized by thick heart muscle and proximity to the coronary arteries. Such cases can be difficult to treat using conventional ablation technologies.
Supple said the system’s flexible catheter and single-freeze design reduced the procedure time compared with Adagio’s first-generation device while still producing deep and durable lesions.
The vCLAS Ultra system uses Adagio’s proprietary ultra-low-temperature ablation technology to deliver single-freeze treatments at temperatures of approximately minus 170 degrees Celsius.
Preclinical data indicate the system could reduce ablation time by 50% to 75% and shorten procedures by as much as 30 minutes compared with the company’s first-generation platform.
The FDA has granted Investigational Device Exemption approval to expand the FULCRUM-VT trial and evaluate the safety and effectiveness of vCLAS Ultra in patients with sustained monomorphic ventricular tachycardia.
“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,” said Todd Usen, Chief Executive Officer of Adagio Medical.
Usen said the system is designed to improve procedural workflow and reduce ablation time for physicians treating ventricular tachycardia.
Adagio previously reported pivotal data showing a 2.4% major adverse event rate, 84% freedom from implantable cardioverter-defibrillator shocks at six months and a 78% relative reduction in amiodarone use.
The company expects an FDA decision on its first-generation ULTA system in the coming months.
