Cryoablation catheters

Arctic Front Advance Pro™ cardiac cryoablation catheter

<p>The Arctic Front Advance Pro™ enables pulmonary vein isolation (PVI) using an anatomical approach during atrial fibrillation (AF) catheter ablation procedures.</p>

Features

Built on the proven Arctic Front™ platform, the Arctic Front Advance Pro™ cryoballoon was developed with a shortened tip profile to allow for improved time-to-isolation visualization,5–11 by bringing the electrodes closer to the vein’s muscular sleeves. This enables physician-tailored dosing protocols11 and may result in improved procedural efficiency.5–13

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).

This image is of the Arctic Front Advance Pro™ cryoballoon.

Arctic Front Advance Pro™ 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.

Clinical evidence

Why pulmonary vein isolation?

PVI is the cornerstone of paroxysmal AF ablation. The Heart Rhythm Society (HRS) consensus statement states that, “PVI is widely accepted as the cornerstone of AF ablation procedures. Electrical isolation of the PVs is recommended during all AF ablation procedures.”14

How does the cryoballoon work? 

The Arctic Front Advance Pro™ 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. Arctic Front Advance Pro™ cryoballoon is available in two balloon sizes.


Specifications

Size
Inflated balloon diameter 23 mm or 28 mm
Catheter size, outer diameter (OD) 10.5 Fr
Overall length 140 cm
Effective length 95 ± 2 cm
Distal tip length 8 mm
Compatibility
Recommended introducer sheath Compatible Medtronic 12 Fr inner diameter sheath (FlexCath Contour™ steerable sheath)
Guidewire compatibility 0.032"–0.035"
Recommended mapping catheter Achieve™ family
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)
AFAPRO23 23 10.5 140 95 ± 2 cm 8
AFAPRO28 28 10.5 140 95 ± 2 cm 8

  1. 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.
  2. 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.
  3. 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.
  4. 1,843 publications (pubmed 25OCT2022,"cryoablation“+“atrial“+“fibrillation“), 95% released 2000–2022, 1,737 publications 2003.

  1. Fürnkranz A, Bologna F, Bordignon S, et al. Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon. Europace. 2016;18(12):1795–1800.
  2. Mugnai G, de Asmundis C, Hünük B, et al. Improved visualisation of real-time recordings during third generation cryoballoon ablation: A comparison between the novel short-tip and the second generation device. J Interv Card Electrophysiol. 2016;46(3):307–314.
  3. Heeger CH, Wissner E, Mathew S, et al. Short tip — big difference? First-in-man experience and procedural efficacy of pulmonary vein isolation using the third-generation cryoballoon. Clin Res Cardiol. 2016;105(6):482–488.
  4. Pott A, Petscher K, Messemer M, Rottbauer W, Dahme T. Increased rate of observed real-time pulmonary vein isolation with third-generation short-tip cryoballoon. J Interv Card Electrophysiol. 2016;47(3):333–339.
  5. Aryana A, Kowalski M, O'Neill PG, et al. Catheter ablation using the third-generation cryoballoon provides an enhanced ability to assess time to pulmonary vein isolation facilitating the ablation strategy: Short- and long-term results of a multicenter study. Heart Rhythm. 2016;13(12):2306–2313.
  6. Sciarra L, Iacopino S, Palamà Z, et al. Impact of the third generation cryoballoon on atrial fibrillation ablation: A useful tool? Indian Pacing Electrophysiol J. 2018;18(4):127–132.
  7. Aryana A, Kenigsberg DN, Kowalski M, et al. Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: Results from the Cryo-DOSING Study. Heart Rhythm. 2017;14(9):1319–1325.
  8. Dahme T, C Kraft, T Stephen, et al. Time-to-isolation guided dosing leads to reduced procedure duration and fluoroscopy time with comparable one year clinical outcomes in cryoballoon pulmonary vein isolation. EP Europace. 2017;19(3):ii64.
  9. Packer DL, Kowal RC, Wheelan KR, et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: First results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013;61(16):1713–1723.
  10. Joglar JA et al. J Am Coll Cardiol. 2024 Mar; 83 (1): 109–279.