Third-generation cryoballoon receives FDA approval, CE Mark

Medtronic announced that its third-generation cryoballoon has received FDA approval and a CE Mark for treatment of certain patients with atrial fibrillation.

The FDA approved the cryoballoon (Arctic Front Advance ST Cryoablation Catheter) for treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal AF. In Europe, the device received a CE Mark for treatment of patients with AF, according to a Medtronic press release.

The new cryoballoon, which was designed for compatibility with the company’s mapping catheter (Achieve), has a 40% shorter tip than its predecessor intended to increase maneuverability when accessing certain pulmonary vein anatomies, according to the release. Following an initial release in limited markets, the cryoballoon will be broadly available this fall.

Results from previous research have indicated associations between cryoballoon technology and shorter procedure times compared with point-by-point radiofrequency ablation, and better treatment outcomes compared with available drug therapies, according to the release.

“By building upon clinical feedback from physicians worldwide, the third-generation system offers the potential for more real-time data and even better maneuverability that may further enhance the procedure,” Karl-Heinz Kuck, MD, director of cardiology at Asklepios Klinik St. Georg, Hamburg, Germany, said in the release.