Expanded FDA approval for Medtronic’s Arctic Front cryoablation catheter

Medtronic's Arctic Front Advance cryoballoon
Medtronic’s Arctic Front Advance cryoballoon

Medtronic has received US 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 (AF) 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, multicentre randomised study that demonstrated superior efficacy of the Medtronic cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy.

“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, section head, Electrophysiology, Cardiovascular Medicine, Cleveland Clinic, Cleveland, USA, 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 have 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 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.

“With this milestone announcement, Medtronic now has the only ablation catheter approved by the FDA to be used a as first-line treatment in the USA to treat AF. The indication expansion demonstrates how Medtronic continues to lead the way in cardiac ablation solutions for arrhythmia management and fill a market need for an early rhythm control strategy for what is an very progressive disease,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “For the millions of Americans who struggle with simple, daily tasks like walking up the stairs or getting the mail because of their AF, the expanded indication offers an alternative treatment option to antiarrhythmic drug therapy.”

The FDA recently expanded the indication for Medtronic cryoablation therapy to include treating patients with drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than six months) as well as the treatment of recurrent symptomatic paroxysmal AF as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.


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