Arctic Front^® Cardiac CryoAblation Catheter is the world’s first cryoballoon indicated for the treatment of paroxysmal atrial fibrillation (PAF). It provides a straightforward and efficient approach to pulmonary vein isolation (PVI). It has a low complication risk and a proven efficacy in eliminating atrial fibrillation (AF). Over 15,000 patients in more than 200 centers worldwide have been treated with the Arctic Front.

How Arctic Front Works (2:35)

Overview

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. It is the first cryoballoon indicated for 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.

How Arctic Front Works

Arctic Front cryoballoon creates circumferential lesions, isolating each pulmonary vein with minimal energy applications, delivering consistent and repeatable results. Arctic Front provides physicians a straightforward three-step approach for PVI.

 How Arctic Front Works (2:35)

Straightforward 3-Step Procedure

Step 1: Wire targeted vein
Arctic Front is deployed in the left atrium and the guidewire is inserted into the target vein.

Step 2: Inflate and Position
The Arctic Front is inflated in the atrium before being advanced toward the wired vein. The balloon is then positioned at the antrum of the pulmonary vein.

Step 3: Occlude and Ablate
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'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.  A circular mapping catheter is then used to confirm pulmonary vein isolation.

Specifications

Arctic Front cryoballoon is supplied sterile and packaged individually. It is a single-use device.

Size

Inflated balloon diameter: 23 mm or 28 mm

Catheter size, outer diameter shaft: 10.5 Fr

Total length: 140 cm

Usable length: 102 cm

Distal tip length: 10 mm

Compatibility

Recommended introducer sheath: FlexCath® Steerable Sheath, 12 Fr

Guide wire: 0.035" maximum

Deflection and Reach

Bidirectional, 45°

Materials

Tip and shaft: Biocompatible copolymer (Pebax®) with barium sulfate blend (BaSO4)

Outer balloon: Polyurethane