Healthcare Professionals

Arctic Front Family of Cardiac Cryoablation Catheters

Cardiac Ablation for Atrial Fibrillation

  • Arctic Front Advance Pro cryoballoon on a white background

Overview

The Arctic Front™ family of cryoballoon catheters are flexible, over-the-wire balloon catheters used to ablate cardiac tissue. The cryoballoons are designed for use with the Achieve™ Mapping Catheters, the FlexCath Contour™ Steerable Sheath, and the Nitron CryoConsole™ system.

The Evolution of the Arctic Front Family of Cryoballoons

Arctic Front cryoballoon catheter with guidewire on navy blue gradient background

Arctic Front was the first anatomical balloon technology using cryo energy on the market. The balloon featured four jets.

Arctic Front Advance™ cryoballoon catheter guidewire on blue gradient background

Arctic Front Advance™ features improved temperature uniformity with EvenCool™ cryo technology (8 jets), enabling more contiguous lesions.*

Arctic Front Advance Pro™ cryoballoon catheter guidewire on gray gradient background

Built on the proven Arctic Front platform, Arctic Front Advance Pro™ is the newest product in the cryoballoon portfolio. It features a 40% shorter tip and is designed to enable improved visualization of time to isolation (TTI).*

Arctic Front Advance Pro Cryoballoon

Arctic Front Advance Pro™ cardiac cryoablation catheter

The next-generation Arctic Front Advance Pro Cryoballoon was developed to allow for improved time-to-isolation visualization,1-6 which enables physician-tailored dosing protocols7 and may result in improved procedural efficiency such as decreased procedure time without compromising efficacy.1-8

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Cryoballoon Product Details

With its proven safety and efficacy profile,9 the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters are approved in the United States to treat drug refractory, recurrent, symptomatic, paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters are also approved to treat recurrent, symptomatic, paroxysmal atrial fibrillation as an alternative to anti-arrhythmic drug therapy as an initial rhythm control strategy. The cryoballoon is used for atrial fibrillation (AF) physiological intervention that delivers a consistent, simple pulmonary vein isolation (PVI) ablation procedure with safe cryo technology. Over one million patients worldwide have been treated with Medtronic cryoablation devices.
Arctic Front Advance™ cryoballoon interior cutaway with six callouts
  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. Thermocouple. Monitors the temperature of the vaporized refrigerant.
  6. Injection tube. Refrigerant is distributed toward the inner balloon surface through the injection tube.

Benefits of Cryoablation

Cryo energy offers several unique features:

  • Cryoadhesion improves contact and stability10
  • Preserves the extracellular matrix and endothelial integrity11
  • Decreases risk of thrombus formation11
  • Demonstrates well demarcated lesions11

The Arctic Front family of cryoballoons use cryo energy, offering several unique features:

  • The cryoballoon creates wide antral lesions,12 creating a difficult path for conduction to cross.
  • Among centers with varying annual ablation volume, cryoballoon demonstrated more consistent outcomes and procedure times.13
  • In the FIRE AND ICE Trial, the cryoballoon met the primary endpoints, and a predefined secondary analysis demonstrated significant improvements in patient outcomes which favored cryoballoon over radiofrequency.14,15

Building on a Proven Platform

Heart atrium illustration depicting the four pulmonary veins and erratic atrial fibrillation signals at entrances

Why PVI?

PVI is the cornerstone of paroxysmal AF ablation. The HRS Consensus Statement states that “PVI is now widely accepted as the cornerstone of AF ablation procedures. Electrical isolation of the PVs is recommended during all AF ablation procedures.”16

Growing Body of Published Literature
5 randomized controlled trials demonstrated no benefit in ablation strategy beyond PVI for AF (n > 1,100).17-21

An Efficient Approach to PVI

The Arctic Front family of cryoballoons is anatomically designed for PVI. Focal radiofrequency (RFC), by comparison, has been adapted to create PVI via a point-by-point approach. When EPs 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 vein12,22
  • Has shorter, more predictable procedure times14 which may allow you to treat more patients in the same amount of time

With over 17 years of clinical experience, over 1,800 peer-reviewed articles,23 and backed by sound clinical evidence, momentum is building for the Arctic Front family of cryoballoons as a safe and consistent way to treat AF. Visit the clinical evidence section to learn more.

View Clinical Evidence

How Does the Cryoballoon Work?

View an animation illustrating how the Arctic Front family of cryoballoons work to create PVI.

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,9 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.

*

Bench data on file.

References

1

Fürnkranz A, Bologna F, Bordignon S, et al. Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon. Europace. December 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. September 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. June 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. December 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. December 2016;13(12):2306-2313.

6

Sciarra L, Iacopino S, Palamà Z, et al. Impact of the third generation cryoballoon on atrial fibrillation ablation: An useful tool? Indian Pacing Electrophysiol J. July-August 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, 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. Europace Abstracts Supplement, 2017.

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. April 23, 2013;61(16):1713-1723.

10

Andrade JG, Dubuc M, Guerra PG, et al. The biophysics and biomechanics of cryoballoon ablation. Pacing Clin Electrophyisol. September 2012;35(9):1162-1168.

11

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.

12

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. February 2015;12(2):283-290.

13

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. January 2017;19(1):48-57.

14

Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. June 9, 2016;374(23):2235-2245.

15

Kuck KH, Fürnkranz A, Chun KRJ, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. October 7, 2016;37(38):2858-2865.

16

Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. October 2017;14(10):e275-e444.

17

Verma A, Jiang C-Y, Betts TR, et al. Approaches to Catheter Ablation for Persistent Atrial Fibrillation. N Engl J Med. May 7, 2015;372(19):1812-1822.

18

Wong KCK, Paisey JR, Sopher M, et al. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circ Arrhythm Electrophysiol. December 2015;8(6):1316-1324.

19

Verma A, Sanders P, Macle L, et al. Selective CFAE targeting for atrial fibrillation study (SELECT AF): clinical rationale, design, and implementation. J Cardiovasc Electrophysiol. May 2011;22(5):541-547.

20

Dixit S, Marchlinski FE, Lin D, et al. Randomized ablation strategies for the treatment of persistent atrial fibrillation RASTA study. Circ Arrhythm Electrophysiol. April 2012;5(2):287-294.

21

Vogler J, Willems S, Sultan A, et al. Pulmonary Vein Isolation Versus Defragmentation: The CHASE-AF Clinical Trial. J Am Coll Cardiol. December 22, 2015;66(24):2743-2752.

22

Okumura Y, Watanabe I, Iso K, et al. Mechanistic Insights into Durable Pulmonary Vein Isolation Achieved by Second-Generation Cryoballoon Ablation. J Atr Fibrillation. April 30, 2017;9(6):1538.

23

Medtronic data on file.