Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug Administration (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 antiarrhythmic drug (AAD) 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 AAD therapy.
Nearly 60 million people worldwide1 are affected by atrial fibrillation (AF). AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke and increased risk of death2-5.
Managing AF can be a lifelong burden for patients, and AAD therapy has been the current standard first-line treatment. However, AAD therapy is ineffective at controlling AF in approximately half of patients treated with drug therapy6-8 and AAD usage frequently causes side effects that can lead many to discontinue treatment.9 Only after experiencing AAD failure, do some patients then go on to receive a catheter ablation.
'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,' said Oussama Wazni, M.D., section head, Electrophysiology, Cardiovascular Medicine, Cleveland Clinic and principle investigator for the STOP AF First clinical trial. '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.'
The Medtronic Arctic Front family of Cardiac Cryoablation Catheters are the first and only catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure, and shorten the time from diagnosis to ablation with effective, efficient, and predictable outcomes.6 Three recent clinical trials showed the safety of the Medtronic cryoballoon and demonstrated the superiority of Arctic Front Cryoballoon ablation for preventing atrial arrhythmia recurrence in patients with paroxysmal AF (PAF) who have not failed AAD therapy.6-8
STOP AF First(opens new window)6, a Medtronic-sponsored, prospective, multicenter, randomized trial, included 225 patients at 24 sites in the U.S. Patients who had never received AAD therapy were randomized to cryoablation or AAD treatment and followed for 12 months. Results, published in the New England Journal of Medicine (NEJM) in Nov. 2020, reported 74.6% of patients in the cryoballoon versus 45.0% in the AAD group (P
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