Arctic Front, a cryoballoon ablation system from Medtronic‘s CryoCath business unit, has received an approval from the FDA. The balloon is delivered via the accompanying FlexCath Steerable Sheath and liquid coolant is pumped in using the CryoConsole control unit.
The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation. The study showed that 69.9 percent of patients treated with Arctic Front were free from atrial fibrillation at one year, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1 percent), and patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.
Arctic Front® Features
•Two balloon diameters: 23 mm and 28 mm
•Double balloon safety system
•Bi-directional deflection (45 degrees maximum)
•Compatible with 12F FlexCath® Steerable Sheath
•102 cm working length
•Uni-directional deflection (135 degrees maximum)
•5 cm reach at 90 degrees deflection
• 65 cm usable length (80 cm with handle)
•12F Inner diameter, 15F outer diameter
•Includes a dilator
•Dilator is compatible with a 0.035-inch guide wire (not included)
Press release: Medtronic Receives FDA Approval for First and Only Cryoballoon Ablation Treatment in the U.S. for Paroxysmal Atrial Fibrillation…
Product page: Arctic Front…