Medtronic gains expanded FDA approval for Arctic Front cryoablation catheters

Medtronic has received expanded FDA approval for its Arctic Front cardiac cryoablation catheters to be used as a first-line treatment for recurrent atrial fibrillation (AFib). The company’s entire line of Arctic Front cryoablation catheters is included in this approval.

According to Medtronic, this is the first time cryoablation has been approved as a first-line treatment for heart rhythm issues. The expanded approval was based on results from the STOP AF First trial, a randomized study that included data from 225 patients receiving care at 24 different U.S. facilities. In that analysis, the treatment success rate was much higher for cryoablation patients than patients who underwent antiarrhythmic drug therapy.

“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 AFib,” Rebeca Seidel, Medtronic’s president of cardiac ablation solutions, said in a prepared statement. “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 a 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 AFib, the expanded indication offers an alternative treatment option to antiarrhythmic drug therapy.”

“Patients can now be referred for a cryoablation to effectively control their AFib rather than trying drug therapy first, potentially allowing them get back to living their lives without the added anxiety of progressing AFib symptoms and potential health complications,” added Oussama Wazni, MD, principle investigator for the STOP AF First trial.

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