21 June 2021 - First and only approval to indicate cryoablation as an initial rhythm control strategy.

Medtronic today announced it received U.S. 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 anti-arrhythmic drug 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 anti-arrhythmic drug therapy.

Read Medtronic press release