Medtronic receives FDA approval, CE mark for Arctic Front Advance Cardiac Cryoballoon

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Medtronic has announced that its Arctic Front Advance Cardiac Cryoballoon has received both FDA approval and CE mark for the treatment of paroxysmal atrial fibrillation (PAF).

A company release states that this second-generation system provides a more efficient approach to treating PAF than point-by-point, radiofrequency ablation.

Arctic Front Advance features the new EvenCool Cryo Technology, which optimises the delivery of coolant inside the balloon. As a result, the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, the target of most AF ablation procedures, and improves physicians’ ability to treat patients with complicated anatomies compared to the original Arctic Front CryoAblation System.


“With Arctic Front Advance, we are now able to more effectively treat a broader range of pulmonary vein anatomies with less effort, which can potentially reduce procedure times,” said Vivek Reddy, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, USA.


Medtronic’s cryoballoon treatment involves a minimally invasive procedure that isolates the pulmonary vein, a source of erratic electrical signals that cause AF, using coolant rather than heat (radiofrequency ablation). Delivered via a catheter, cryoballoon technology is associated with faster procedure times versus point-by-point, radiogrequency ablation. Studies have shown that 73% of Medtronic cryoablation patients achieved freedom from AF at one year, a clinically significant increase in success over AF drug therapy1,2.


“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, director of cardiology, Asklepios Klinik St Georg, Hamburg, Germany. “The second-generation system builds on this solid foundation, while offering more sophisticated features that should benefit both the physician and patient.”


The first-generation Arctic Front Cardiac CryoAblation Catheter System, currently approved in both the United States and Europe, is the world’s leading cryoballoon system indicated for the treatment of PAF. The system has experienced rapid worldwide adoption and clinical experience since its introduction onto the market, having been used to treat approximately 35,000 patients in more than 400 medical centres in 25 countries.


References:


1 Andrade JG, Khairy P, Guerra PG, et al. Efficacy and safety of cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. September 2011;8(9):1444-1451.


2 Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. August 2009;2(4):349-361.