Cryoablation catheters

Arctic Front Advance™ cardiac cryoablation catheter

<p>The Arctic Front Advance™ over-the-wire balloon catheter is designed to&nbsp;enable pulmonary vein isolation (PVI) during atrial fibrillation ablation procedures.</p>

Features

Cryoballoon indications

The Arctic Front Advance™ and Arctic Front Advance Pro™ cardiac cryoablation catheters are the only catheters indicated for the treatment of recurrent, symptomatic, paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. The Arctic Front™ family is also indicated for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal, and persistent atrial fibrillation (episode duration less than six months).

Arctic Front Advance™ cryoballoon components

  1. Guidewire lumen. Facilitates injection of contrast to confirm occlusion of the vein; placement of the guidewire through the lumen helps direct the catheter to the targeted vein.
  2. Outer balloon. Safety feature to contain the refrigerant in the unlikely event that the inner balloon is compromised; the outer balloon is maintained under constant vacuum.
  3. Inner balloon. Refrigerant is delivered into the inner balloon and vacuumed back into the console to achieve the freezing process.
  4. Pull wires. Help deflect the catheter 45 degrees in either direction.
  5. Termocouple. Monitors the temperature of the vaporized refrigerant.
  6. Injection tube. Refrigerant is distributed toward the inner balloon surface through the injection tube.
This is an illustration of the interior of the Arctic Front Advance™ cryoballoon with six callouts.

Cryoablation benefits

Cryo energy offers several unique features:

  • Cryoadhesion improves contact and stability1
  • Preserves the extracellular matrix and endothelial integrity2
  • Decreases risk of thrombus formation2
  • Demonstrates well demarcated lesions2

 

The Arctic Front Advance™ uses cryo energy, offering these benefits:

  • Wide antral lesions,3 creating a difficult path for conduction to cross
  • More consistent and predictable outcomes and procedure times4

Clinical evidence

An efficient approach to pulmonary vein isolation

The Arctic Front Advance™ is anatomically designed for PVI. Focal radiofrequency (RF), by comparison, has been adapted to create PVI via a point-by-point approach. When electrophysiologists have both cryo and RF capabilities, they may have the ability to treat a broader base of patients.

The cryoballoon:

  • Is an anatomical approach for PVI, creating long, contiguous circumferential lesions surrounding the pulmonary vein3,5
  • Has shorter, more predictable procedure times6 which may allow you to treat more patients in the same amount of time7
  • With more than 17 years of clinical experience, more than 2,000 peer-reviewed articles,8 and backed by sound clinical evidence, momentum is building for the Arctic Front™ family of cryoballoons as a safe and consistent way to treat atrial fibrillation.

How does cryoballoon work? 

The Arctic Front Advance™ cryoballoon is inserted over a guidewire or mapping catheter from the Achieve™ family and through the FlexCath Contour™ steerable sheath into the left atrium, where it can be inflated and advanced to the target vein. Nitrous oxide is delivered via an injection tube to the inner surface of the balloon. As the refrigerant vaporizes, it absorbs the heat from the surrounding tissue and is vacuumed back into the Nitron CryoConsole™ system.


Specifications

Size
Inflated balloon diameter 23 mm or 28 mm
Catheter size, outer diameter (OD) 10.5 Fr
Overall length 134 cm
Effective length 95 ± 2 cm
Distal tip length 13.5 mm
Compatibility
Recommended introducer sheath Compatible Medtronic 12 Fr inner diameter sheath (FlexCath Contour™ steerable sheath)
Guidewire compatibility 0.032"–0.035"
Deflection and reach
Deflection Bidirectional 45°
Material
Tip and shaft Biocompatible copolymer (Pebax™) with barium sulfate blend (BaSO4)
Outer balloon Polyurethane

Ordering information

Item number Size (mm) Catheter size OD (Fr) Overall length (cm) Effective length (cm) Distal tip length (mm)
2AF234 23 10.5 134 95 ± 2 cm 13.5
2AF284 28 10.5 134 95 ± 2 cm 13.5
  1. Andrade JG, Dubuc M, Guerra PG, et al. The biophysics and biomechanics of cryoballoon ablation. Pacing Clin Electrophyisol. 2012;35(9):1162–1168.
  2. 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. 2005;46(10):1902–1912.
  3. Kenigsberg DN, Martin N, Lim HW, Kowalski M, Ellenbogen KA. Quantification of cryoablation zone demarcated by pre- and post-procedural electroanatomical mapping in atrial fibrillation patients using the 28 mm second generation cryoballoon. Heart Rhythm. 2015;12(2):283–290.
  4. Providencia R, Defaye P, Lambiase PD, et al. Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: is cryoablation more reproducible? Europace. 2017;19(1):48–57.
  5. Okumura Y, Watanabe I, Iso K, et al. Mechanistic insights into durable pulmonary vein isolation achieved by second-generation cryoballoon ablation. J Atr Fibrillation. 2017;9(6):1538.
  6. Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–2245.
  7. Kowalski M, Su WW, Holbrook R, et al. Impact of Cryoballoon Ablation on Electrophysiology Lab Efficiency During the Treatment of Patients With Persistent Atrial Fibrillation: A Subanalysis of the STOP Persistent AF Study. J Invasive Cardiol. 2021.
  8. 1,843 publications (pubmed 25OCT2022,"cryoablation“+“atrial“+“fibrillation“), 95% released 2000-2022, 1,737 publications 2003.