Medtronic (NYSE:MDT) announced today that it received FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters.
Fridley, Minn.-based Medtronic’s Arctic Front family of catheters treat recurrent symptomatic paroxysmal atrial fibrillation (AFib) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy.
The expanded indication provided by the FDA came after the STOP AF First prospective study showed that the Medtronic cryoablation procedure demonstrated superior efficacy in preventing atrial arrhythmia recurrence compared to the use of AAD therapy, according to a news release.
Medtronic’s cryoablation therapy recently garnered expanded indication from the FDA to treat patients with drug-refractory recurrent symptomatic paroxysmal and persistent AFib (episode duration less than six months). It also picked up an indication for the treatment of recurrent symptomatic paroxysmal AFib as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.
“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 U.S. to treat AF,” president of Medtronic’s cardiac ablation solutions business Rebecca Seidel said in the release. “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.
“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.”
