Healthcare Professionals
Arctic Front Advance
Cardiac CryoAblation Catheter
Arctic Front Advance 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.
Overview
Overview
New EvenCool Cryo Technology
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.
Building on a Proven Platform: Arctic Front
An Efficient Approach to PVI
The Arctic Front cryoballoon provides a straightforward and efficient approach for isolating the pulmonary veins in the treatment of paroxysmal atrial fibrillation.
- Arctic Front creates circumferential lesions1, using 2-3 applications per vein to achieve PVI2
- Arctic Front does not require 3D mapping, reducing procedural complexity
- Short, predictable procedure times allow you to treat more patients3
A Proven Approach to PVI
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.
Benefits of Cryoablation
The Arctic Front system uses cryo energy which offers a number of unique safety features:
- Cryoadhesion improves contact and stability, minimizing the amount of fluoro used
- Preserves the extracellular matrix and endothelial integrity1
- Decreases risk of thrombus formation1
- Demonstrates well demarcated lesions1
A Safe Approach to PVI
- Clinical studies report no incidence of atrial-esophageal fistulas or perforation2,4
- Low reported occurrence of left atrial tachycardia post procedure4
- Cryoablation procedure event rate in the STOP AF pivotal study was a low 3.1%2
Important Safety Information
Catheter ablation should only be conducted in a fully equipped electrophysiology laboratory by trained physicians.
Phrenic Nerve Injury (PNI) can be minimized by positioning Arctic Front as antral as possible and vigilantly monitoring the phrenic nerve with pacing during cryotherapy delivery. Stop ablation immediately if evidence of phrenic nerve impairment is observed.
In most cases, including STOP AF, PNI with cryotherapy is a transient complication. PV stenosis can be minimized by not positioning Arctic Front within the tubular portion of the pulmonary vein. Do not inflate the balloon while the catheter is positioned inside the pulmonary vein. Always inflate the balloon in the atrium and then position at the pulmonary vein ostia.
Potential complications, while infrequent, can occur during catheter ablation. Please review the device manual for detailed information regarding contraindications, warnings, precautions, and potential complications.
References
1
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.
2
Medtronic Inc., Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA premarket approval.
3
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.
4
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.
