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Arctic Front Advance™ Cardiac Cryoablation Catheter

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 Advance™  and Arctic Front Advance Pro™ Cardiac Cryoablation Catheters are part of the Arctic Front™ Cardiac Cryoablation Catheter System and is used in conjunction with the FlexCath Contour™ Steerable Sheath.

With its low complication risk and a proven efficacy, the Arctic Front Cardiac Cryoablation Catheter Family is the leading cryoballoon to treat Atrial Fibrillation (AF).1    

The Arctic Front Cardiac Cryoablation Catheter Family allows physicians to reach and treat pulmonary veins quickly and efficiently because of its anatomically designed shape.2, 10- 13  In addition, this balloon design gives physicians an advantage by enabling creation of circumferential and continuous scar tissue lines around the pulmonary veins in a single application.18

The evolution of the Arctic Front Family of Cryoballoons

Arctic Front cryoballoon 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 with Achieve mapping catheter 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 with Achieve mapping catheter 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 on a white background

Arctic Front Advance Pro™ Cryoballoon

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

Arctic Front Advance
 

Value of Arctic Front Advance Pro™ Cryoballoon Catheter

  • Improved visualisation of TTI
  • Improved catheter manoeuvrability
  • Built on a proven platform 

Cryoballoon Product Details

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 stability3
  • Preserves the extracellular matrix and endothelial integrity4
  • Decreases risk of thrombus formation4
  • Demonstrates well demarcated lesions4
The cryoballoon uses cryo energy, offering several unique features:
  • The Arctic Front Cardiac Cryoablation Catheter Family creates wide antral lesions5
  • Among centres with varying annual ablation volume, the Arctic Front Cardiac Cryoablation Catheter Family demonstrated more consistent outcomes and procedure times.6
  • The Arctic Front Cardiac Cryoablation Catheter Family shows favourable results for re-ablation and cardiovascular related re-hospitalisation rates compare to RF.7

 

View clinical evidence

A proven approach to PVI

Safe and Effective Alternative To Anti-Arrhythmic Drug Therapy

The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial demonstrated that cryoballoon ablation with the Arctic Front Cardiac Cryoablation Catheter Family is a safe and effective alternative after anti-arrhythmic medication for the treatment of patients with symptomatic paroxysmal AF, for whom at least one anti-arrhythmic drug has failed. The Arctic Front Cardiac Cryoablation Catheter Family demonstrated freedom from AF at 12 months of 69.9% (114/163) and 7.3% (6/82) for the drug arm.15

Real-World results With current generation

Results from the STOP AF Post Approval Study (PAS) demonstrated the Arctic Front Cardiac Cryoablation Catheter Family safety, efficacy, and lesion durability in patients with drug-refractory recurrent symptomatic PAF. Freedom from AF was 81.6% at 12 months and 73.8% at 24 months and 68.1% at 36 months on or off anti-arrhythmic drugs.16

A new gold standard in AF Ablation

In the FIRE AND ICE Trial, the Arctic Front Cardiac Cryoablation Catheter Family met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency (RFC).14 In a predefined secondary analysis, relative to RFC, the Arctic Front Cardiac Cryoablation Catheter Family demonstrated significantly fewer cardiovascular hospitalizations and repeat ablations.7


FIRE AND ICE re-do study

The FIRE AND ICE re-do study18 retrospectively characterized reablations performed during the pivotal FIRE AND ICE trial8 

  • n = 89; 36 cryoballoon (CB) and 53 radiofrequency (RFC) index ablations
  • Median time to reablation was 173 days for CB and 182 days for RFC
At reablation procedure:
  • Fewer PV reconnections occurred with index CB (1.4 ± 1.1) vs. RFC (2.1 ± 1.4) ablation
  • Fewer reablation lesions were required with index CB (2.5 ± 1.5) vs. RFC (3.3 ± 1.3) ablation (P = 0.015)

 

 

 

Graph with data on reablations from the Fire and Ice Re-Do Study


Figure 2. Pulmonary vein (PV) reconnections identified during repeat ablation.

A, Mean number of reconnected PVs according to patient group. In the radiofrequency current (RFC)-Redo cohort a significantly higher mean number of reconnected PVs per patient than in the cryoballoon (CB)-Redo cohort was observed during repeat ablation (P=0.01).

B, Percentage of patients with 0 to 4 reconnected PVs per patient according to patient group.

A safe approach to PVI

Designed with PVI in mind:

Cryo energy safely removes heat from the tissue to create durable lesions.17

STOP AF 12-month safety results:

The cryoablation procedure event rate was 3.1% overall. There were 3.1% major AF events in the ablation arm (5/163), compared to the drug arm at 8.5% (7/82).15

STOP AF post approval study (PAS) 24-month safety results:

The cryoablation major adverse event rate was 5.8% (20/344).16 The most frequent complication was phrenic nerve injury (PNI) present post-ablation in 11 (3.2%) of 344 patients.  PNI persisted beyond 36 months in 1 (0.3%) of 344 patients

FIRE AND ICE 12-month safety results:

The cryoballoon event rate was 10.2% (40/374) compared to an event rate of 12.8% (51/376) with Radiofrequency (RFC).14

Phrenic Nerve Injury

The most commonly reported adverse event with Arctic Front™ Cryoballoon Catheter Family was phrenic nerve injury. Advancements in experience and technology have shown these rates to decrease over time.

NOTE: The FIRE AND ICE Trial included both Arctic Front™ and Arctic Front Advance™ cryoballoons.

For further European results and references please see the brochure.

See results

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 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 ostium.

Potential complications, while infrequent, can occur during catheter ablation. Please review the device manual for detailed information regarding contraindications, warnings, precautions, and potential complications.

This material is for Healthcare Professionals in countries with applicable health authority product registrations.

Important: Always refer to the Instructions For Use (IFU) packaged with the product/e-IFU for complete instructions, indications, contraindications, warnings, and precautions. 

For further information, contact your local Medtronic representative and/or consult the Medtronic website at cema.medtronic.com

CE marked according to the law.

*

Bench data on file.

References

1

Kuck KH, et.al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. NEJM April 2016. DOI: 10.1056/NEJM oa1602014

2

Klein et al. FAST-PVI study. Europace. 2014.

3

Okumura et al. Mechanistic insights into durable pulmonary vein isolation achieved by second-generation cryoballoon ablation. J Atrial Fibrillation. 2017, 2019; 9:6.

4

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.

5

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.

6

Providencia R., Defaye P., Lambiase P.D., Pavin D., Cebron J.-P., Halimi F., FAnselme R., Srinivasan N., Albenque J.-P., Boveda S. Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: Is cryoablation more reproducible? Europace. 2017;19(1):48-57.

7

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): 2235-45

8

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]

9

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.

10

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.

11

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.

12

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.

13

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.

14

Kuck KH, et al. Repeat Ablation for Atrial Fibrillation Recurrence Post Cryoballoon or Radiofrequency Ablation in the FIRE AND ICE Trial. Circ Arrhythm Electrophysiol. 2019;12:e007247. DOI: 10.1161/CIRCEP.119.007247

15

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;61(14): 1713-23.

16

Knight B, et al. Second Generation Cryoballoon Ablation in Paroxysmal Atrial Fibrillation Patients: 24 Month Safety and Efficacy from the STOP-AF Post Approval Study. Presented at HRS 2017 (Abstract).

17

Ahmed, H., Neuzil, P., Skoda, J., et al. The permanency of pulmonary vein isolation using balloon cryoablation catheter. J Cardiovasc. Electrophysiol. July 2010; 21 (7): 731-737.

18

Fürnkranz et al. Improved procedural efficacy of pulmonary vein isolation using the novel second-generation cryoballoon. Journal of Cardiovascular Electrophysiology; doi: 10.1111/jce.12082.