Clinical Evidence
Numerous studies have demonstrated the safety and efficacy of the POLARx™ Cryoablation System in the treatment of paroxysmal atrial fibrillation. It has been studied and is in use in multiple countries across the globe.
- In several comparative studies POLARx Cryoablation System demonstrated a comparable safety and efficacy profile to a competitive technology12 ,14-19, 21, 22
- POLARx showed different cryoablation metrics with lower nadir temperatures, shorter time to -40°C and longer thaw times but similar acute outcomes12-15, 17, 21-23, 25
- Real-Time TTI vizualization is recorded more often with POLARx12, 15, 22, 25
***Updated analysis with corrected data
| Procedural Characteristic | FROzEN-AF (28 mm balloon) | POLARx FIT Extension Arm (28 mm / 31 mm balloon) |
| General Anesthesia (%) | 78.5% | 100% |
| Conscious Sedation/MAC (%) | 21.5% | - |
| Procedure Time (min) | 91 ± 41 min | 101 ± 59 min |
| LA Dwell Time (min) | 59 ± 33 min | 51 ± 22 min |
| Fluoroscopy Time (min:sec) | 12:52 ± 11:12 min | 7:10 ± 11:18 min |
| Grade 3-4 Occlusion* (%) | 95.9% (69.9% - Grade 4) | 97.7% (66.4% / 77.6% - Grade 4) |
| Single Shot Success* (%) | 55.9% | 35.3% / 62.1% |
Mean ± SD
*Only ablations with duration >60 sec included in ablation counts
FROZEN AF (POLARx)¹
(n=325)
12-MONTH EFFICACY
Freedom from atrial arrhythmias
12-MONTH SAFETY
Freedom from primary event
Extended POLARx FIT arm1
(n=50)
12-MONTH EFFICACY
Freedom from atrial arrhythmias
12-MONTH SAFETY
Freedom from primary event**
Procedural Characteristics | Overall (n=24) |
Overall procedural time (min), median (IQR) | 90 (60–110) |
Overall fluoroscopy time (min), median (IQR) | 15.5 (12–22.3) |
Anatomical variants Right common pulmonary trunks, n (%) Left common pulmonary trunks, n (%) Additional PV branches, n (%) |
2 (8.3) 1 (4.2) 3 (12.5) |
Number of applications needing the 31 mm size, n (%) | 64 (51.6) |
Minimal reached temperatures LSPV (°C), median (IQR) LIPV (°C), median (IQR) RSPV (°C), median (IQR) RIPV (°C), median (IQR) |
-52.0 (−54.5–−50.5) -49.0 (−52.0–−48.0) -50.0 (−54.0–−45.5) -50.0 (−57.0–−48.0) |
In-hospital AF recurrences, n (%) | 2 (8.3) |
Periprocedural complications Groin hematoma, n (%) Pericardial effusion, n (%) Cardiac tamponade, n (%) Phrenic nerve palsy, n (%) Thromboembolic complications, n (%) |
1 (4.2) 0 (0) 0 (0) 0 (0) 0 (0) |
| Biophysical parameters and single shot success | TTI <60s (n=852) | TTI ≥60s (n=282) | No TTI (n=776) | p-value |
| Time to -40°C (s) | 30.6 ± 7.4* | 34.2 ± 10.7 | 35.0 ± 15.3 | p<0.001 |
| Nadir Temperature (°C) | -58.3 ± 5.8 | -56.6 ± 5.9 | -54.1 ± 6.8 | p<0.001 |
| Thaw to °C (s) | 21.1 ± 6.7 | 19.3 ± 5.5 | 17.6 ± 6.7 | p<0.001 |
| Occlusion Grade (4) | 89% | 77% | 63% | p<0.001 |
| Occlusion Grade (3) | 11% | 22% | 29% | |
| Single Shot Rate | 95% | 82% | 60% | p<0.001 |
Data reported when available. Not all ablations reported full data, results are mean + SD or percentage.
*Significantly less than the other 2 groups.
Procedural characteristics⁴
| Procedural characteristics⁴ | |
| Mean procedure time | 68.2 min |
| Mean left atrial dwell time | 46.6 min |
| Mean fluoroscopy time | 15.6 min |
Performance and biophyscial characteristics⁴
| Performance and biophysical characteristics⁴ | |
| Acute pulmonary vein isolation | 96.80% |
| Grade 3-4 occlusion | 98.20% |
| Single-shot success | 71.20% |
| Mean cryoablation per PV | 1.5 |
| Mean nadir temp | -56.3°C |
| Mean time to isolation | 50 sec |
Safety⁵
Primary safety event rate
Major advers events No patient suffered from atrial esophageal fistula or pulmonary vein stenosis
12-month efficacy⁵
Arrhythmia recurrence free rate
AF
recurrence free rate
| Performance and biophysical characteristics⁶ | |
| Acute pulmonary vein isolation | 99.70% |
| Real-time PVI visualization | 71.90% |
| Minimum CB temperature | −57.9±7°C |
| Precedure time | 92±41 min |
| Fluoro time | 15±10 min |
Freedom from
recurrence
at 226 ± 115 days
| Multi-center | Single-center |
| Spera, et al, 2022⁷ Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation | Anic, et al 2021¹¹ Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience |
| Fassini, et al., 2022⁸ Novel cryoballoon technology for a successful pulmonary vein isolation: acute outcome and follow up from a large multicenter Italian clinical setting | Schiavone, M. et al 202427 Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study. |
| Iacopino, et al., 2022⁹ Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry | Liao Y., et al., 202428 Quantifying pulmonary vein antrum contact area with novel dual-sized cryoballoon to optimize pulmonary vein isolation |
| Martin, et al., 2022¹⁰ Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long‑term outcomes in a multicentre clinical study | van Boven N., et al., 202529 Prospective evaluation of antral lesion size of the 31-mm size of a novel size-adjustable cryoballoon: Results of the BETTER-FIT study |
| Procedural characteristics | PLX | AFA PRO | p-value |
| Mean minimal cryoballoon temp | -56.1 ± 8.3°C | -46.9 ± 10.1°C | < 0.0001 |
| Real-time visualization of PVI | 71% of PVs | 46% of PVs | < 0.001 |
| Procedure time | 54.5 ± 17.1 min | 59.4 ± 18.6 min | 0.0509 |
| Periprocedural Major or Minor complications | No difference | ||
12-month efficacy
POLARx
Arctic Front Advance Pro
Freedom of AF or atrial tachycardia
See key outcomes
| Procedural characteristics | PLX | AFA | |
| Procedure time | 78.6 ± 38.1 | 79.4 ± 25.8 | P=0.55 |
| Phrenic nerve palsy | 0% | 0.10% | P =1 |
| Immediate or 30-day complications | No difference | ||
See key outcomes
| Nadir cryoballoon temp | −54.6 ± 7.6°C |
| time to −40°C | 34.1 ± 13.7 s |
| time to isolation | 49.8 ± 33.2 s |
| Variables | PLX | AFA Pro | p-value |
| Procedure duration, minutes | 60.50 ± 14.23 | 73.43 ± 13.26 | 0.001 |
| Fluoroscopy duration, minutes | 12.83 ± 6.03 | 17.23 ± 7.17 | 0.01 |
| Contrast used, mL | 62.17 ± 7.84 | 60.17 ± 8.03 | 0.9 |
| Number of occlusion | 1.09 ± 0.3 | 1.19 ± 0.5 | 0.6 |
| Time to -40ºC, seconds | 30.43 ± 12.53 | 47.96 ± 16.91 | < 0.001 |
| Nadir temperature, ºC | -58.13 ± 6.26 | -49.63 ± 6.19 | < 0.001 |
| Real time isolation | 101 (84%) | 84 (70%) | 0.009 |
| Isolation time, seconds | 34.47 ± 21.23 | 34.18 ± 26.79 | 0.9 |
| Isolation temperature, ºC | -35.5 ± 13.36 | -29.58 ± 11.27 | 0.002 |
| Thaw time to 0ºC, seconds | 19.31 ± 7.9 | 10.0 ± 4.13 | < 0.001 |
See key outcomes
| Acute procedural complications | PLX | AFA Pro | p-value |
| Transient right-sided phrenic nerve palsy | 3.0% | 3.0% | 1.000 |
| Multi-center | Single-center |
| Yap, et al., 2022¹⁵ Comparison of the 1‑year clinical outcome of a novel cryoballoon to an established cryoballoon | Badertscher et al., 2023²⁰ Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation |
| Knecht, et al., 2022¹⁵ Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome | Imnadze, et al., 2022²¹ Two competing cryoballoon technologies for single shot pulmonary vein isolation: first experiences with the novel system |
| Honarbakhsh, et al., 2022¹⁷ POLARx Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation | Tilz, et al., 2021²² Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation – The Prospective ICE-AGE-X Study |
| Guckel, et al., 2022¹⁸ Impact of pulmonary vein variant anatomy and cross‑sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single‑shot guided pulmonary vein isolation¹⁸ | Creta, et al., 2021²³ First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison |
| Yap, et al., 2021¹⁹ Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience | Kochi et al., 2021²⁴ Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform |
| Pannone L., et al., 202530 Cryoballoon Ablation with the POLARx FIT or the Arctic Front Advance Pro for Paroxysmal Atrial Fibrillation: A Health Economic Analysis |
- No differences in acute PV isolation, procedure & fluoroscopy & ablation time, minimal esophageal temperature, risk of phrenic nerve palsy or thromboembolic events.
- Balloon nadir temperatures were lower for POLARx in all PVs.
- Higher rate of TTI recording in the inferior PVs with POLARx.
* mbase, MEDLINE, Web of Science, Cochrane, and Google Scholar databases were searched until 12/01/2022 for studies comparing PLX vs. AFA in PVI patients
| Multi-center | |
| Assaf, Yap et al²⁶ Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta‐analysis |
References
1. Ellenbogen KA et al, One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial. J Cardiovasc Electrophysiol. 2024 Apr;35(4):832-842. doi: 10.1111/jce.16220. Epub 2024 Mar 6. PMID: 38448797.
(https://doi.org/10.1111/jce.16220)
2. Su et al. Clinial Application of a Novel 31mm Cryoballoon for Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation: Procedural Data from the FIT arm of FROzEN-AF. HRS 2023
3. Martin et al., Biophysical parameters and time to isolation of pulmonary veins with a novel cryoballoon: results of POLAR ICE study, EP Europace, Volume 24, Issue Supplement_1, May 2022, euac053.078
(https://doi.org/10.1093/europace/euac053.078)
4. Martin CA, Tilz RRR, Anic A, et al. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. Epub 2023 Feb 23. PMID: 36786515.
(https://doi.org/10.1111/jce.15861)
5. Luik A, Anic A, Asmundis C, et al. Long-term success rates of a stable, low pressure cryoballoon for the treatment of paroxysmal atrial fibrillation: Results of the prospective, international, multicenter POLAR-ICE Study. Presented at: 2023 ESC Congress, Aug. 25-28, 2023; Amsterdam, Netherlands.
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(https://doi.org/10.1007/s10840-022-01200-5)
11. Anic, et al., Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience, Europace 2021,
(https://doi.org/10.1093/europace/euab018)
12. Heeger C-H, Popescu SS, Inderhees T. et al. Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study. Europace. 2023 Aug 2;25(9):euad248.
(https://doi.org/10.1093/europace/euad248)
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(https://doi.org/10.1093/europace/euad286)
14. Mojica J, Lipartiti F, Al Housari M, et al. Procedural safety and efficacy for pulmonary vein isolation with the novel POLARx™ Cryoablation System: A propensity score matched comparison with the Arctic Front™ Cryoballoon in the setting of paroxysmal atrial fibrillation. J Atr Fibrillation. 2021 Jun 30;14(1):20200455.
(https://doi.org/10.4022/jafib.20200455)
15. Yap, et al., Comparison of the 1‑year clinical outcome of a novel cryoballoon to an established cryoballoon, J Interv Cardiovasc Electrophysiol. 2022
(https://doi.org/10.1007/s10840-022-01262-5)
16. Knecht, et al., Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome, Europace 2022,
(https://doi.org/10.1093/europace/euac094)
17. Honarbakhsh, et al., POLARx Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation, Europace 2022
(https://doi.org/10.1093/europace/euac100)
18. Guckel, et al., Impact of pulmonary vein variant anatomy and cross‑sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single‑shot guided pulmonary vein isolation, J Cardiovasc Electrophysiol. 2022
(https://doi.org/10.1007/s10840-022-01279-w)
19. Yap, et al., Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience, J Cardiovasc Electrophysiol. 2021,
(https://doi.org/10.1111/jce.14915)
20. Badertscher et al., Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation, Europace (2023) 25, 1–8. 2023 Dec 6;25(12):euad329.
(https://doi.org/10.1093/europace/euad329)
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(http://doi.org/10.31083/j.rcm2304118)
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(https://doi.org/10.1111/jce.14951)
24. Kochi et al, Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform, J Cardiovasc Electrophysiol. Feb 2021
(https://doi.org/10.1111/jce.14930)
25. Assaf A, Rohit E. Bhagwandien, Tamas Szili-Torok, Sing-Chien Yap. Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis, IJC Heart & Vasculature 42 2022,
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26. Assaf A, Rohit E. Bhagwandien, Tamas Szili-Torok, Sing-Chien Yap. Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta‐analysis, J Cardiovasc Electrophysiol. 2021,
(https://doi.org/10.1111/jce.15182)
27. Schiavone, M.; Fassini, G.; Moltrasio, M.; Majocchi, B.; Tundo, F.; Casati, F.; Tondo, C. Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study. J. Clin. Med. 2024, 13, 1259.
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29. Nick van Boven, Rohit Bhagwandien, Sip A. Wijchers, Mark Hoogendijk, Bakhtawar Khan Mahmoodi, Sing-Chien Yap, Prospective evaluation of antral lesion size of the 31-mm size of a novel size-adjustable cryoballoon: Results of the BETTER-FIT study, Heart Rhythm O2, Volume 6, Issue 4, 2025, Pages 393-401, ISSN 2666-5018.
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(https://doi.org/10.36469/001c.133223)
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