Arctic Front Advance
Cardiac Cryoablation Catheter

Arctic Front Advance Cardiac CryoAblation Catheter

Building on the demonstrated safety and efficacy of its predecessor1, the Arctic Front Advance® System is the leading cryoballoon approved in the U.S. to treat drug refractory, symptomatic, paroxysmal atrial fibrillation. The cryoballoon has a low complication risk and a proven efficacy in treating atrial fibrillation (AF). Over 180,000 patients in more than 50 countries worldwide have been treated with the cryoballoon.

Overview

AF Advance

EvenCool Cryo Technology

Arctic Front Advance Cryoballoon features EvenCool Cryo Technology, which optimizes the delivery of coolant inside the balloon. By allowing flexibility in balloon positioning to ablate the PVs, this product feature 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 Cryoballoon

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.

  • Creates circumferential lesions1, using minimal applications per vein to achieve PVI2
  • 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

  • Low reported occurrence of left atrial tachycardia post procedure4
  • The cryoablation procedure event rate in the STOP AF Post Approval Study was 5.9% which included a 3.1% phrenic nerve injury rate.5

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.
  5. Knight BP, Novak PG, Sangrigoli R, et al. 12-Month Clinical Outcomes Following Pulmonary Vein Isolation (PVI) Using the Arctic Front Advance® Cryoballoon: Interim Results from the STOP-AF Post Approval Study. HRS 2015 (PO01-60).

How Arctic Front Advance Works

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.

Straightforward 4-Step Procedure

arcticfront_01_position
Step 1: Access Targeted Vein
The cryoballoon is deployed in the left atrium and the Achieve Mapping Catheter is inserted into the target vein.

arcticfront_02_inflate
Step 2: Inflate and Position
The cryoballoon is inflated in the atrium before being advanced toward the wired vein. The balloon is then positioned at the antrum of the pulmonary vein.

arcticfront_03_complete
Step 3: Complete Occlusion
Contrast dye is then injected through the guide-wire lumen to assess vein occlusion via fluoroscopy.

arcticfront_04_signal
Step 4: Ablate and Assess PVI
The cryoballoon ablates where the balloon is in contact with the tissue. The device’s anatomical shape and large surface area creates circumferential lesions with minimal energy applications. The Achieve Mapping Catheter is then used to confirm pulmonary vein isolation.

How Arctic Front Works (2:02, 12.3 MB)

Specifications

The 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: 95 ± 2 cm
Distal tip length: 13 mm

Compatibility

Recommended introducer sheath: FlexCath® Steerable Sheath, 12 Fr
Guide wire: 0.032" – 0.035"

Deflection and Reach

Bidirectional, 45°

Materials

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

Last updated: 29 Apr 2016

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