Medtronic’s Arctic Front cryoablation system
Medtronic (NYSE:MDT) enrolled the first of up to 572 patients in its Fire & Ice trial, the largest clinical study to date to compare 2 atrial fibrillation ablation systems.
Medtronic will compare its Arctic Front cardiac cryoablation system to Biosense Webster’s Carto system-guided Thermocool catheter in a prospective, randomized, multinational European study spanning 20 medical centers.
Paroxysmal AF is a condition in which patients exhibit an intermittently irregular heartbeat that can last for minutes or days at a time, and patients enrolled in the Fire & Ice study have failed at least 1 antiarrhythmic drug, according to a press release.
Medtronic’s Arctic Front system blocks electrical signals that trigger erratic rhythms in the heart’s upper chambers by isolating the pulmonary veins using freezing. Traditional ablation methods isolate the triggers by heating with radiofrequency energy.
"The freezing helps the balloon maintain contact with the heart tissue during the procedure, allowing for greater catheter stability," according to a Medtronic press release. "Cryoablation has been shown to be faster for physicians to use than a point-by-point catheter, and it has been proven more effective than anti-arrhythmic drug therapy in treating patients with paroxysmal atrial fibrillation."
The study’s primary endpoint aims for absence of the erratic heart rhythms without the use of antiarrhythmic drugs and without persistent procedure-related adverse effects.
Atrial fibrillation is the most common and among the most under-treated heart rhythm disorders, affecting more than 7 million people worldwide, according to the release.
Medtronic obtained FDA pre-market approval for the Arctic Front cryoballoon ablation system in Dec. 2010. It notched first use in Jan. 2011 at the Mayo Clinic. More than 15,000 patients have received treatment with Arctic Front in more than 200 centers worldwide, according to Medtronic’s website.
The Fridley, Minn.-based med-tech titan recently hit an obstacle with another of its atrial fibrillation treatment devices when the FDA’s circulatory devices panel said “not yet” to Medtronic’s Phased radiofrequency ablation system.
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