Medtronic's Arctic Front Advance ST Cryoballoon Approved for Atrial Fibrillation in United States and Europe

May 12, 2015—Medtronic plc announced that the Arctic Front Advance ST cryoablation catheter has received US Food and Drug Administration approval for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. In Europe, where the cryoballoon has a broader indication, the Arctic Front Advance ST cryoballoon has received CE Mark approval for the treatment of patients with atrial fibrillation. The product will be broadly available to physicians in fall 2015 after a limited market release.

According to Medtronic, the Arctic Front Advance system is a third-generation cryoballoon with a 40% shorter tip than the previous generation. The new system is designed to help physicians visualize ablation success in real time with the Achieve mapping catheter, as well as to allow increased maneuverability for accessing some pulmonary vein anatomies.

The technologies currently offered as part of the system are the Arctic Front Advance ST cryoballoon, which isolates the pulmonary veins for the treatment of atrial fibrillation; the FlexCath Advance steerable sheath, which helps deliver and position the cryoballoon in the left atrium; the Achieve mapping catheter, an intracardiac electrophysiology recording catheter used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation; the Freezor Max cardiac cryoablation catheter, which is a single-point catheter used to provide additional ablations as needed; and the CryoConsole, which houses the coolant, electrical, and mechanical components that run the catheters during a cryoablation procedure.

According to the company, cryoballoon technology is associated with shorter procedure times than point-by-point radiofrequency ablation and better treatment outcomes than currently available drug therapies.

Medtronic’s Arctic Front Advance system, which works by isolating the pulmonary veins, has been shown to improve quality of life for patients and significantly reduce paroxysmal atrial fibrillation symptoms, with patients experiencing reduction in atrial fibrillation episodes, palpitations, fatigue, rapid heartbeat, swelling, and syncope.

Prof. Karl-Heinz Kuck, MD, who treated the first patient with the Arctic Front Advance ST cryoballoon, commented in Medtronic’s press release, “I have had the opportunity to utilize the cryoballoon technology since its inception more than a decade ago. By building upon clinical feedback from physicians worldwide, the third-generation system offers the potential for more real-time data and even better maneuverability that may further enhance the procedure.” Dr. Kuck is Director of Cardiology at Asklepios Klinik St. Georg in Hamburg, Germany.