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– First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy – Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence DUBLIN, June 21, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug Administration (FDA) expanded approval for the Arctic Front™ Family of Cardiac Cryoablation Catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. The expanded indication is based on results from STOP AF First, a prospective, multicenter randomized study that demonstrated superior efficacy of the Medtronic cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy.
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