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BioWorld - Wednesday, February 4, 2026
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Home » Medtronic expands FDA approval for cryoablation device
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Medtronic expands FDA approval for cryoablation device

June 22, 2021
By Ana Mulero
Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic.
Medical technology Regulatory Cardiovascular 510(k) FDA

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