|Illustration of the Medtronic Arctic Front Advance Cryoballoon placed in the left superior inferior pulmonary vein|
CHICAGO--Medtronic's ($MDT) Arctic Front Cryoballoon ablation catheter for paroxysmal atrial fibrillation is comparable to Biosense Webster's competing Thermocool, the results of a postmarket, head-to-head comparative trial found.
At the American College of Cardiology meeting in Chicago, Medtronic presented data showing that the Cryoballoon met its primary efficacy endpoint of noninferiority to the Thermocool, as measured by a reduction in arrhythmia recurrence and the need for antiarrhythmic drug therapy and/or reablation. The devices' safety profiles were similar as well.
The aptly named Fire and Ice trial reflects the devices' different ablation mechanisms. The Thermocool uses heat in the form of radiofrequency ablation to isolate the pulmonary vein and destroy the offending heart tissue, while the Cryoballoon delivers a coolant to achieve the same result. In addition, use of the Cryoballoon does not involve 3-D mapping, as is the case with the Thermocool.
Principal investigator Dr. Karl-Heinz Kuck said during his presentation at ACC that although 30% of afib patients are both symptomatic and nonresponsive to drugs, only 4% of them receive catheter ablation.
Kuck said the Cryoballoon will increase the low penetration rate of ablation because it is easy to operate. "My dream is first afib episode, take the patient to the lab. But you need a tool that is safe, simple, and can be handled by the average doctor, not by the highly specialized doctor like you," he told the audience.
FDA-approved in 2015, the Cryoballoon has been used in more than 180,000 procedures in more than 50 countries around the world, Medtronic said. Meanwhile, fast-growing electrophysiology specialist Biosense Webster is one of the few bright spots in Johnson & Johnson's ($JNJ) struggling device portfolio.
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