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Medtronic Gets FDA Expanded Approval For Arctic Front Family Of Cardiac Cryoablation Catheters

Medtronic plc (MDT) said Monday that it received U.S. Food and Drug Administration expanded approval for the Arctic Front Family of Cardiac Cryoablation Catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug or 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.

Atrial fibrillation is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke and increased risk of death.

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