Cryoballoon wins FDA approval, CE mark for paroxysmal AF
Medtronic today announced that its Arctic Front Advance Cardiac Cryoballoon has received FDA and CE mark approval for the treatment of paroxysmal atrial fibrillation.
The second-generation system employs EvenCool Cryo Technology to optimize the delivery of coolant inside the balloon. It involves a minimally invasive procedure that isolates the pulmonary vein using coolant rather than heat, as with radiofrequency ablation.
Cryoballoon technology is associated with faster procedure times vs. point-by-point, radiofrequency ablation, and 73% of patients using cryoablation were free from AF at 1 year, according to a press release issued by the manufacturer.
“The original Arctic Front technology has become a standard for AF ablation based on its safety, efficacy and relative ease of use,” said Karl-Heinz Kuck, MD, director of cardiology at Asklepios Klinik St. Georg in Hamburg, Germany. “The second-generation system builds on this solid foundation while offering more sophisticated features that should benefit both the physician and patient.”