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FDA Approves Medtronic’s Arctic Front For ‘First-Line’ Treatment For AFib

 
• By Reed Miller

The new approval allows Medtronic to promote cryoablation as the first option for patients with recurrent symptomatic paroxysmal atrial fibrillation. Previously, it was only approved for patients who had already tried to manage their atrial fibrillation with drugs.

MEDTRONIC'S ARCTIC FRONT ADVANCE CRYOBALLOON • Source: Medtronic PLC

Medtronic plc’s Arctic Front cardiac cryoablation system is the first cardiac ablation device approved by the US Food and Drug Administration for “first-line” treatment of symptomatic paroxysmal (occasional) atrial fibrillation, the agency announced on 21 June.

The FDA approved a PMA supplement to expand Arctic Front’s indications to include the treatment of recurrent symptomatic paroxysmal...

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