Medtronic’s Cardiac Cryoballoon gets regulatory approval

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Tuesday, August 28, 2012
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3 l2 L# N7 d- {6 {; BMinneapolis, MN - Medtronic announced that its Arctic Front Advance Cardiac Cryoballoon has received both U.S. Food and Drug Administration (FDA) approval and CE (Conformité Européenne) Mark for the treatment of paroxysmal atrial fibrillation (PAF). With the only cryoballoon system currently on the market worldwide, Medtronic’s second-generation system provides a more efficient approach to treating PAF than point-by-point, radiofrequency (RF) ablation. Arctic Front Advance features the new EvenCool Cryo Technology, which optimizes 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. 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 centers in 25 countries.