Medtronic has been authorised by US Food and Drug Administration (FDA) to use the Arctic Front Advance ST Cryoablation Catheter for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF).
In addition, the Cryoballoon secured CE Mark for the treatment of patients with AF in Europe.
The Arctic Front Advance ST Cryoballoon is designed for use in a minimally invasive procedure to isolate pulmonary veins, which are a source of erratic electrical signals that cause AF.
The third-generation cryoballoon, an integral part of the system, has a 40% shorter tip than its predecessors, and helps physicians visualise ablation success in real-time with the Achieve Mapping Catheter, while allowing increased manoeuvrability to access some pulmonary vein anatomies.
Medtronic Cardiac and Vascular Group AF Solutions business 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."
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The Arctic Front Advance System has proven to be effective in improving quality of life for patients and reducing paroxysmal AF symptoms, with patients experiencing reduction in AF episodes, palpitations, fatigue, rapid heartbeat, swelling and syncope.
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, and has been used to treat more than 120,000 patients in more than 50 countries worldwide.
The technologies currently 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.
AF is claimed to be the most common and one of the most undertreated heart rhythm disorders, affecting more than 33.5 million people worldwide.