June 21, 2021 – Medtronic plc (Dublin, Ireland) 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 company says that 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.
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.
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 6 months) as well as the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.
Medtronic has pioneered cryoablation technology, with an industry-leading and extensive body of evidence, including proven safety and efficacy in treating AF. To date, nearly one million patients have been treated with the Medtronic cryoablation therapy worldwide.