Irish medical technology firm Medtronic has obtained approval from the US Food and Drug Administration (FDA) for its Arctic Front Advance ST Cryoablation Catheter to treat patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF).
In Europe, the company also received CE mark approval for Arctic Front Advance ST Cryoballoon to treat patients with AF.
The Arctic Front Advance ST Cryoballon is said to be used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that result in atrial fibrillation.
Medtronic cardiac and vascular group AF Solutions business general manager and vice-president Reggie Groves said: "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."
According to Medtronic, the Arctic Front Advance System is the only cryoballoon system that received approval in the US to treat paroxysmal AF and in Europe to treat AF.
Currently, the technologies offered under the system include the Artic Front Advance ST Cryoballoon, FlexCath Advance Steerable Sheath, Achieve Mapping Catheter, Freezor MAX Cardiac Cryoablation Catheter and CryoConsole.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.