Medtronic's cryoballoon nets EU, FDA approval

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Medtronic's Arctic Front Advance cardiac cryoballoon ablation device has received both FDA approval and CE Mark for the treatment of paroxysmal atrial fibrillation (PAF).

Arctic Front Advance features the new EvenCool Cryo technology, which delivers the coolant inside the balloon. Minneapolis-based Medtronic said its 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).