The device, indicated for treating an irregular heartbeat, won FDA clearance as well as CE Mark approval in the European Union, the medical device giant announced today.
If it’s predecessor was any indication, the device could see rapid adoption among clinicians worldwide.
Medtronic’s Arctic Front systems block electrical signals that trigger erratic rhythms in the heart’s upper chambers by isolating the pulmonary veins using freezing in order to treat paroxysmal atrial fibrillation, a condition in which in which patients exhibit an intermittently irregular heartbeat that can last for minutes or days at a time.
AF is one of the "most common and one of the most under-treated heart rhythm disorders," increasing a patient’s risk of stroke and potential heart failure, according to a press release.
The next-gen Arctic Front Advance includes Medtronic’s new EvenCool Cryo Technology, which aims to produce a more uniformly cold surface of the balloon and make it easier for physician’s to isolate the pulmonary veins.
"We anticipate this next generation balloon will be enthusiastically received by physicians worldwide," Medtronic vice president and AF Solutions general manager Reggie Groves said in prepared remarks. "Our cadence of product launches showcases significant enhancements: This is the second revolutionary balloon-based medical technology we’ve launched in the past 18 months in the U.S. to treat AF."
The medical device maker early this year enrolled the 1st patient in its Fire & Ice ablation study, comparing its 1st generation Arctic Front system to Biosense Webster’s Carto system-guided Thermocool catheter.
The Fire & Ice study, expected to enroll up to 572 patients, is the largest study to date comparing 2 atrial fibrillation ablation systems.