Adagio Medical, Inc., the developer of the iCLAS™ technology, the company’s ultra-low temperature intelligent continuous lesion ablation system for the treatment of cardiac arrhythmias, announces the successful completion of its chronic atrial fibrillation animal study, performed in collaboration with the LIRYC Research Institute of Bordeaux, France. The results clearly demonstrate that the company’s technology creates transmural, continuous, and durable lesions in both atria.
The four-month chronic animal study was conducted using the company’s multi-shape ultra-low temperature cryoablation catheters. The ablation targets included isolation of pulmonary veins, left and right atrial appendages, superior vena cava, posterior wall of the left atrium, and the right ventricular outflow tract. Confirmation of linear block was completed using absence of EGMs/PV potentials, pacing for entrance/exit block, and with electroanatomical voltage maps. At the end of the four-month study period, there was no electrical reconnection at any of the linear lesions.
“The new ultra-low temperature provided by Adagio opens up for fast and effective EP treatment,” says Prof. Michel Häissaguerre, MD, Professor at the Hôpital Cardiologique du Haut-Lévêque, Bordeaux-Pessac, and Director of the Electrophysiology and Heart Modeling Institute, LIRYC. “The Adagio cryoablation catheter is both versatile and intuitive to use. In addition to simply creating the common PV lesions, the catheter can be used to precisely ablate atrial and ventricular tachycardias.”
“It was encouraging to see first-hand that even with the short dwell time the lesions created by Adagio’s catheter were transmural, continuous and most importantly durable after four months,” says Dr. Mélèze Hocini, MD, Associate Professor at the Hôpital Cardiologique du Haut-Lévêque, Bordeaux-Pessac.
“Nitrogen has been previously used as a freezing agent in various surgical cryoablation procedures including cardiac epicardial applications. However, it is our patented near-critical nitrogen technology that has made it possible to use this ultra-low temperature cryogen in an endocardial catheter for the first time. It allows us to consistently make long and truly continuous endocardial lesions with transmural penetration achieving lethal tissue temperatures of minus 40 degrees Celsius and below,” says Alex Babkin, PhD, Sc.D., Chief Technology Officer of Adagio Medical, Inc. “We’re pleased that the human clinical results are consistent with what we found in the LIRYC pre-clinical studies.”