Medtronic (MDT) Wins FDA Nod and CE Mark for Arctic Front Advance ST Cryoballoon
Tuesday, May 12, 2015
Source: Device Space
Medtronic plc (NYSE: MDT) today announced the Arctic Front Advance® ST Cryoablation Catheter has received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation. In Europe, where the Cryoballoon has a broader indication, Arctic Front Advance ST Cryoballoon has received CE (Conformité Européenne) Mark for the treatment of patients with atrial fibrillation. An integral part of the Arctic Front Advance® System, the third-generation cryoballoon has a 40 percent shorter tip than the previous generation, designed to help physicians visualize ablation success in real-time with the Achieve® Mapping Catheter, as well as allow increased maneuverability for accessing some pulmonary vein anatomies.