Arctic Front Family of Cardiac Cryoablation Catheters

Cardiac Ablation for Atrial Fibrillation

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™ Advance Steerable Sheath and the CryoConsole™.  

The Evolution of the Arctic Front Family of Cryoballoons

Arctic Front Cryoballoon

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

Arctic Front Advance Cryoballoon

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

Arctic Front Advance Pro Cryoballoon

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 Cryoballoon

The next generation Arctic Front Advance Pro™ Cryoballoon was developed to allow for improved time-to-isolation visualization1-6, which enables physician-tailored dosing protocols7 and may result in improved procedural efficiency such as decreased procedure time without compromising efficacy1-8.

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Cryoballoon Product Details

With its proven safety and efficacy profile, the Arctic Front family of cryoballoons are approved in the U.S. to treat drug refractory, recurrent, symptomatic, paroxysmal AF (PAF).9 The cryoballoon is used for AF physiological intervention that delivers a consistent, simple pulmonary vein isolation (PVI) ablation procedure with safe cryo technology.  Over 500,000 patients worldwide have been treated with the cryoballoon.10

Arctic Front Advance Pro Cryoballoon cross-section

1. Guide wire lumen. Facilitates injection of contrast to confirm occlusion of the vein. Placement of the guide wire 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 stability11
  • Preserves the extracellular matrix and endothelial integrity12
  • Decreases risk of thrombus formation12
  • Demonstrates well demarcated lesions12

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

  • The cryoballoon creates wide antral lesions13, creating a difficult path for conduction to cross.
  • Among centers with varying annual ablation volume, cryoballoon demonstrated more consistent outcomes and procedure times.14
  • In the FIRE AND ICE Trial, the cryoballoon met the primary endpoints and a predefined secondary analyses demonstrated significant improvements in patient outcomes which favored cryoballoon over radiofrequency.15,16

BUILDING ON A PROVEN PLATFORM

PVI is the cornerstone of AF ablation

WHY PVI?

Pulmonary vein isolation 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.”17

Growing Body of Published Literature
Five randomized controlled trials demonstrated no benefit in ablation strategy beyond PVI for AF (n > 1,100).18-22

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 vein13,23
  • Has shorter, more predictable procedure times15 which may allow you to treat more patients in the same amount of time

With more than 12 years of of clinical experience, over 700 peer-reviewed articles10, and backed by sound clinical evidence, momentum is building for the Arctic Front family of cryoballoons as a safe and consistent way to treat PAF. Visit the clinical evidence section to learn more.

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 AF9, 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.

For more detailed product information about the Arctic Front family of cryoballoons, including specs, visit Medtronic Academy.

*

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, 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 Apr 23; 61(14):1713-1723.

10

Medtronic data on file.

11

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

12

Sarabanda AV, 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.

13

Kenigsberg D, et al. 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. 2014; 12(2):283-90.

14

Providencia R., 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.

15

Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23): 2235-45.

16

Kuck KH, 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. 2016; Oct 7;37(38): 2858-2865.

17

Calkins H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm. 2017 May 12. [Epub ahead of print]

18

Verma A., Jiang C.-Y., Betts T.R., Chen J., Deisenhofer I., Mantovan R., Macle L., Morillo C.A., Haverkamp W., Weerasooriya R., Albenque J.-P., Nardi S., Menardi E., Novak P., Sanders P. Approaches to Catheter Ablation for Persistent Atrial Fibrillation. New England Journal of Medicine. 2015;372(19):812-822.

19

Wong K.C.K., Paisey J.R., Sopher M., Balasubramaniam R., Jones M., Qureshi N., Hayes C.R., Ginks M.R., Rajappan K., Bashir Y., Betts T.R. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circulation: Arrhythmia and Electrophysiology. 2015;8(6):1316-1324.

20

Verma A., Sanders P., MacLe L., Champagne J., Nair G.M., Calkins H., Wilber D.J. Selective CFAE targeting for atrial fibrillation study (SELECT AF): Clinical rationale, design, and implementation. Journal of Cardiovascular Electrophysiology. 2011;22(5):541-547.

21

Dixit S., Marchlinski F.E., Lin D., Callans D.J., Bala R., Riley M.P., Garcia F.C., Hutchinson M.D., Ratcliffe S.J., Cooper J.M., Verdino R.J., Patel V.V., Zado E.S., Cash N.R., Killian T., Tomson T.T., Gerstenfeld E.P. Randomized Ablation Strategies for the Treatment of Persistent Atrial Fibrillation RASTA study. Circulation: Arrhythmia and Electrophysiology. 2012;5(2):287-294.

22

Vogler J., Willems S., Sultan A., Schreiber D., Lüker J., Servatius H., Schäffer B., Moser J., Hoffmann B.A., Steven D. Pulmonary Vein Isolation Versus Defragmentation the CHASE-AF Clinical Trial. Journal of the American College of Cardiology. 2015;66(24):2743-2752.

23

Okumura et al. Mechanistic Insights into Durable Pulmonary Vein Isolation Achieved by Second Generation Cryoballoon Ablation. J Atrial Fibrillation. 2017;9:6.