ATS Medical, Inc., a Minneapolis, MN company, is reporting that its Argon-based cryoablation system ATS CryoMaze™, designed to perform the Cox-Maze III procedure for concomitant atrial fibrillation treatment during open heart surgeries, has been given the CE Mark of approval by European regulators.
From the product page:
For the treatment of cardiac arrhythmias, the ATS CryoMaze™ Surgical Ablation System is the only surgical cardiac ablation option that can safely and effectively complete all lesions in the "gold standard" Cox-Maze III procedure with a single product and one energy source. And the versatility of the system makes it adaptable to any procedure or surgical approach.
Cryothermy involves the employment of extremely cold temperatures to ablate specific tissue while leaving underlying connective tissues largely unaffected. This allows the cardiac surgeon to encircle the pulmonary veins with lines of scar tissue to block transmission of erratic electrical signals that trigger atrial fibrillation (atrial fib). The advantage of cryothermy over heat-based therapies is that freezing preserves tissue integrity and minimizes the risk of endocardial thrombus associated with heat-based sources.
Findings from a 1997 study quoted in the product brochure:
All atrial lesions in the study were found to be transmural. No adverse effect on coronary sinus noted with the ATS CryoMaze probe application for up to 120 seconds. Under purposeful misapplication directly on the esophagus in in-vivo studies, minimal acute damage was noted in doses up to 90 seconds. Cryoadhesion offers certainty in lesion placement, minimizing risk of collateral damage.