FDA Approves First Cryoballoon to Treat AF

Reed Miller

December 21, 2010

December 21, 2010 (Minneapolis, Minnesota) — The Arctic Front system (Medtronic, Minneapolis, MN) is the first cryoablation balloon catheter available in the US after the FDA approved the technology for the treatment of drug-refractory paroxysmal atrial fibrillation late last week [1].

Medtronic's premarket approval application for Arctic Front was based on the Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) trial, which compared cryoballoon ablation with antiarrhythmic drug therapy in 245 patients at 26 centers. In the trial, 69.9% of patients treated with Arctic Front were free from atrial fibrillation at one year, defined as no detectable AF during the period, no use of study drugs, and no AF interventions. Only 7.3% of the patients treated with drug therapy only were AF-free at one year.

Five patients in the Arctic Front group had procedure-related adverse events, but the two groups were similar for the combined safety end point, which included adverse events related to either the treatment or disease.

The cryoablation procedure blocks the electrical pathways that cause AF by creating a scar around the orifice of the pulmonary vein. The cryoballoon can isolate the pulmonary vein in as little as one freeze, unlike the traditional radiofrequency ablation approach, which requires the operator to ablate one spot at a time. The frozen balloon sticks to the tissue during the procedure, which keeps the catheter stable during the ablation process, according to the company.

The Arctic Front system includes the Arctic Front cryoballoon, the FlexCathsteerable sheath, the FreezorMAX single-point cryoablation catheter used to provide additional ablations as needed, and the CryoConsole, which houses the coolant and electrical and mechanical components that run the system.