Arctic Front Advance
Cardiac CryoAblation Catheter
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Cardiac CryoAblation Catheter
Arctic Front Advance™ Cardiac CryoAblation Catheter is the second generation of the world’s first cryoballoon indicated for the treatment of paroxysmal atrial fibrillation (PAF). Building upon the proven safety and efficacy of the original Arctic Front Cryoballoon, this technology provides an efficient approach to pulmonary vein isolation (PVI). The original Arctic Front product has a low complication risk and a proven efficacy in treating atrial fibrillation (AF). Over 180,000 patients in more than 1,300 centers worldwide have been treated with the cryoballoon.
Arctic Front Advance features the new EvenCool™ Cryo Technology, which optimizes the delivery of coolant inside the balloon. By allowing more flexibility in balloon positioning to ablate the PVs, this new product enhancement is designed to improve physicians’ ability to treat patients with a wide variety of vein anatomies with less effort.
The Arctic Front cryoballoon provides a straightforward and efficient approach for isolating the pulmonary veins in the treatment of paroxysmal atrial fibrillation.
The North American Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) trial, a 26-center randomized, controlled study, confirmed the safety and efficacy of Arctic Front. 69.9% of patients achieved treatment success at 12 months.
The Arctic Front system uses cryo energy which offers a number of unique safety features:
Sarabanda AV, Bunch TJ, Johnson SB, et al. Efficacy and safety of circumferential pulmonary vein isolation using a novel cryothermal balloon ablation system. J Am Coll Cardiol. November 15, 2005;46(10):1902-1912.
Medtronic Inc., Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA premarket approval.
Kojodjojo P, O’Neill MD, Lim PB, et al. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. September 2010;96(17):1379-1384.
Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. November 2008:10(11):1271-1276.
Arctic Front Advance cryoballoon creates circumferential lesions, isolating each pulmonary vein with minimal energy applications, delivering consistent and repeatable results. Arctic Front Advance provides physicians a straightforward four-step approach for PVI.
Arctic Front Advance is deployed in the left atrium and the Achieve™ Mapping Catheter is inserted into the target vein.
The Arctic Front Advance is inflated in the atrium before being advanced toward the wired vein. The balloon is then positioned at the antrum of the pulmonary vein.
Contrast dye is then injected through the guide-wire lumen to assess vein occlusion via fluoroscopy. The cryoballoon ablates where the balloon is in contact with the tissue. Arctic Front Advance’s anatomical shape and large surface area creates circumferential lesions with minimal energy applications. On average, PVI is typically achieved after two to three, 4-minute applications of energy per vein. The Achieve Mapping Catheter is then used to confirm pulmonary vein isolation.
Arctic Front Advance cryoballoon is supplied sterile and packaged individually. It is a single-use device.
Inflated balloon diameter: 23 mm or 28 mm
Catheter size, outer diameter shaft: 10.5 Fr
Total length: 140 cm
Usable length: 95 ± 2 cm
Distal tip length: 10 mm
Recommended introducer sheath: FlexCath® Steerable Sheath, 12 Fr
Guide wire: 0.032' – 0.035'
Tip and shaft: Biocompatible copolymer (Pebax®) with barium sulfate blend (BaSO4)
Outer balloon: Polyurethane
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .