Medtronic’s Cryoablation Catheter Wins U.S., EU Approval

Medtronic’s Artic Front Advance ST Cryoablation Catheter has won FDA approval for treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation; and CE Mark approval for treatment of patients with atrial fibrillation, a wider indication than its American counterpart. The Irish devicemaker made the announcement Tuesday.

The device is part of the Artic Front Advance System, which is the only cryoballoon system to have the above indications in the U.S. and Europe.

The third-generation cyroblation catheter is equipped with a 40 percent shorter tip than the previous model, the company says. The innovation is meant to allow better maneuverability when accessing certain pulmonary vein anatomies, those that cause erratic electrical signals triggering atrial fibrillation.

The device relies on coolant instead of radiofrequency heat, which is associated with longer procedure times. The catheter will have a limited release followed by a wider launch this fall.

Atrial fibrillation affects more than 33.5 million people globally. — Jason Scott