Discussion:
The FROZEN AF study demonstrates the safety and effectiveness of the
POLARx cryoballoon, the trial met effectiveness and safety endpoints in
patients with drug-refractory paroxysmal atrial fibrillation, with a
high 1-year recurrence free rate or 79.9% and 0% phrenic nerve palsy.
Additionally, the FIT extension arm demonstrates the promise of the
variable size cryoballoon, with 84% freedom from AF recurrence and a
promising safety profile.