FDA Clears Medtronic Catheter for Atrial Fibrillation

The FDA has approved Medtronic’s Arctic Front Advance ST Cryoablation Catheter for patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

The device uses coolant rather than heat and isolates the pulmonary veins to treat atrial fibrillation. It has been shown to significantly reduce sporadic atrial fibrillation symptoms, with patients experiencing reduction in atrial fibrillation episodes, palpitations, fatigue, rapid heartbeat, swelling, and syncope.

Compared to previous versions, the third-generation cryoballoon has a shorter tip designed to help physicians visualize ablation success in real-time and allow increased maneuverability for accessing some pulmonary vein anatomies.

"The next-generation Arctic Front Advance ST Cryoballoon builds upon the successful performance of the Arctic Front Advance System, and its shorter tip was designed in response to physicians' needs in a real-world, clinical setting," said Reggie Groves, vice president and general manager of AF Solutions, part of the Cardiac and Vascular Group at Medtronic, in a press release.

After a limited US market release, the product will be broadly available to physicians beginning in fall 2015.