Medtronic (NYSE:MDT) said today that it’s enrolled the 1st patients in a European study of its Arctic Front Advance cryoablation balloon, aiming to demonstrate its utility as a front-line treatment for paroxysmal atrial fibrillation.
The Fridley, Minn.-based medical device giant noted that recent updates to European guidelines put ablation as a 1st-line therapy for some patients with sympomatic PAF. Cryoballoon ablation is not a front-line treatment in the U.S., but half of all patients don’t respond to drug therapy, according to a press release.
Medtronic said the 218-patient Cryo-First trial is designed to compare initial treatment using the Arctic Front Advance device with medication alone, at 12 centers in Europe.
"With the prevalence of AF expected to increase exponentially over the next generation, we believe that cryoballoon ablation therapy may safely and effectively address the disease before it progresses, improving outcomes and quality of life for patients, and reducing healthcare costs," Reggie Groves, general manager of Medtronic’s AF solutions business, said in prepared remarks.
“For select patients with symptomatic paroxysmal AF and minimal or no heart disease, this therapy – with its established safety profile – has potential as a 1st-line treatment, providing valuable clinical insights and evidence for future therapeutic solutions," added Dr. Heinz-Friedrich Pitschner of the Kerckhoff-Klinik Heart Center and chairman of the Cryo-First steering committee.
Medtronic won pre-market approval for the Arctic Front cryoballoon ablation system in December 2010. The company is also evaluting the Arctic Front device in its Fire & Ice trial, comparing it to Biosense Webster’s Carto system-guided Thermocool catheter in a prospective, randomized, multinational European study spanning 20 medical centers.
