Approval for the Artic Front cardiac cryoablation catheters has been expanded by the FDA for treatment of recurrent symptomatic paroxysmal AF as an initial rhythm control strategy. The expanded indication is based on results from the STOP AF trial, in which efficacy of this type of cryoablation was demonstrated for preventing atrial arrhythmia recurrence compared to use of antiarrhythmic drug therapy.

Antiarrhythmic therapy for controlling AF is ineffective in ~half of the patients, and drug therapy may cause side effects leading to discontinuation. Only after antiarrhythmic drug therapy failure, some patients undergo catheter ablation.

Oussama Wazni, M.D., section head, Electrophysiology, Cardiovascular Medicine, Cleveland Clinic and principle investigator for the STOP AF First clinical trial said: "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."

Source: press release Medtronic, June 21, 2021