Research & Development
Medtronic receives US FDA expanded approval for Arctic Front Family of Cardiac Cryoablation Catheters
22 June 2021 -

Medtronic plc (NYSE: MDT), the global company involved in medical technology, announced on Monday that it has received expanded approval from the United States Food and Drug Administration (FDA) for the Arctic Front Family of Cardiac Cryoablation Catheters to treat 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 outcome from STOP AF First, a prospective, multicentre randomised study that showcases superior efficacy of the Medtronic cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy.

Oussama Wazni, MD, section head, Electrophysiology, Cardiovascular Medicine, Cleveland Clinic and principal investigator for the STOP AF First clinical trial, said, 'Expanded FDA approval, coupled with the growing body of clinical evidence, demonstrate cryoablation as a first-line treatment is a more effective solution for preventing atrial arrhythmia recurrence. With this new indication, physicians now have more options to treat AF earlier, and we've seen that patients do better when treated earlier. Patients can now be referred for a cryoablation to effectively control their AF rather than trying drug therapy first, potentially allowing them get back to living their lives without the added anxiety of progressing AF symptoms and potential health complications.'



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