Going beyond the conventional

POLARx™: Setting a new standard in cryoablation

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 technology^{12 ,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 outcomes^{12-15, 17, 21-23, 25}
Real-Time TTI vizualization is recorded more often with POLARx^{12, 15, 22, 25}

Find out more

Read the POLARx Clinical Compendium

Find publication summaries and key take aways from the latest cryoablation studies.

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Key POLARx performance

FROzEN-AF US IDE Clinical Trial

In a global, prospective, single-arm study, researchers evaluated the safety and effectiveness of the POLARx Cryoablation System (PLX) for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF). At 12 months, data revealed a 96.0%*** freedom from primary safety events for POLARx and 100% for POLARx FIT (extension arm). Freedom from atrial arrhythmias was 79.9% for POLARx and 82.0% for POLARx FIT¹. The findings also point to an increase in Grade 4 occlusions and in successful single-shot therapy with POLARx FIT at 31 mm cryoballoon expansion.²

***Updated analysis with corrected data

Global

44 Centers

Prospective

Single-arm

325 Patients
50 FIT patients (extension arm²)

Objective:

Evaluate the safety and effectiveness of the Boston Scientific POLARx Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).

50 patients were treated to collect safety and effectiveness data on the POLARx FIT expandable (28 mm and 31 mm) cryoballoon (CB) catheter.

Acute procedural results

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

Chronic safety and efficacy

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**

12-month data on POLARx™ FIT showed low arrhythmia recurrence and high freedom from primary safety events, after a high rate of Grade 3 or 4 occlusions achieved.¹
The choice of balloon sizes** with POLARx FIT may assist in overcoming challenges related to variability in patient PV size and geometry with the 31 mm CB achieving high-grade 3-4 vein occlusion, lowering the LA dwell and fluoroscopy times and increasing the single-shot isolation rate.

**(31 and 28 mm)

Key POLARx performance

Proof-of-Concept clinical trial

In a single-center, single-arm observational investigation, researchers assessed the acute performance of the POLARx FIT novel-size, adjustable, second-generation cryoballoon system in paroxysmal AF ablation procedures.

Italy

Single-center

Single-arm

24 FIT consecutive patients

Objective:

Assess the acute performance of the POLARx FIT novel-size, adjustable, second-generation cryoballoon system in paroxysmal AF (PAF) ablation procedures.

Acute procedural results

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)

The use of the dual-size feature has helped to reach an easier PVI in various clinical scenarios.
The new generation POLARx FIT showed comparable easy maneuverability as POLARx, with an overall high acute success rate and low periprocedural complication rates.
POLARx FIT may show similar procedure and fluoroscopy times in the presence of standard PV anatomy but offers significant intraprocedural flexibility to the operator.
The increased antral occlusion capability potentially reduces phrenic nerve injury.

Key POLARx performance

POLAR ICE multicenter study

In a prospective, non-randomized study conducted from 2020–2023 in multiple experienced European centers, researchers using the POLARx Cryoablation System for pulmonary vein isolation found the device to be effective, safe and efficient.³'⁴'⁵

19 Centers

Prospective

Single-arm

399 Patients

Objective:

Post-market clinical follow-up study to evaluate the safety and effectiveness of the POLARx Cryoablation Balloon for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) using real-world data.

Acute procedural results

TTI, Biophysics, and efficacy³

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%	p<0.001
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.

Access biophysical parameters and TTI results

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

Chronic safety and efficacy

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

In the POLAR ICE real-world registry there was a low safety event rate (4.6%).⁵
Biophysical data suggest that good occlusion may allow for faster freeze and lower nadir temperatures, resulting in longer thaw times.³
The one-year arrhythmia recurrence free rates were 83.5%, with an AF recurrence free rate of 88.1%.⁵
Lower nadir temperatures and a longer thawing time were acute predictors of long-term clinical success.⁵

Key POLARx performance

ANTARCTICA observational study

In a multicenter prospective assessment of the POLARx system's efficacy and safety for PVI in an early-adopter setting of acute efficacy and safety, researchers found that use of POLARx resulted in a high rate of real-time pulmonary vein isolation (PVI) visualization and durable lesion creation. Following a short 25-patient learning curve, experienced operators also incurred significantly fewer adverse safety events.⁶

DE, IT

6 Centers

Prospective

Single-arm

317 PLX patients

Objective:

Assess the procedural efficacy, mid-term outcome, safety and characteristics of the novel POLARx CB for PVI.

Acute procedural results

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

Chronic results

Freedom from
recurrence
at 226 ± 115 days

First multi-center study reporting on the acute efficacy, mid-term outcome and safety of POLARx-based PVI.
High rate of real-time PVI visualization.
The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P=0.018).
The rate of recurrence-free survival after mean of > 6 months short-term follow-up was 86.1%.

polarx-antarctica-observational-study-bar

Key POLARx performance

Other POLARx studies

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., 2024²⁸Quantifying 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

POLARx Comparative performance

Prospective ICE AGE 1 Study

In a 1-year follow-up study comparing 103 consecutive patients with paroxysmal or persistent AF who underwent PVI with POLARx (PLX) and 102 consecutive patients previously treated with Arctic Front Advance Pro™ (AFA Pro), POLARx demonstrated comparable safety and efficacy with lower cryoballoon nadir temperatures and improved rates of real-time visualization of PVI.¹²

Germany

Single-center

Prospective

PLX vs AFA Pro

103 PLX patients
102 AFA patients

Objective:

Evaluate the efficacy, safety, and 1-year clinical outcomes of the POLARx CB compared to the Arctic Front Advance Pro CB (AFA).

Acute procedural results¹²

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

Chronic efficacy¹²

12-month efficacy

POLARx

Arctic Front Advance Pro

Freedom of AF or atrial tachycardia

See key outcomes

POLARx and Arctic Front showed similar safety, efficacy, and recurrence-free survival rates at 1 year.
A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx.

polarx-heeger-finding-clinical-trial-bar

POLARx Comparative performance

UK comparative study

A large United Kingdom multicenter study of 1,688 AF patients compared the POLARx Cryoablation System (PLX) to Arctic Front Advance™ (AFA) and found comparable safety and efficacy between the systems. The POLARx cohort of 844 patients experienced a low rate of procedural complications (0.8%) with no reported phrenic nerve palsy.¹³

12 Centers

Prospective

PLX vs AFA

844 PLX patients
844 AFA patients

Objective:

Compare POLARx and Arctic Front in terms of safety, procedural metrics, and efficacy in a UK large-scale multi-center study.

Acute procedural results

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

Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%.
Cryoablation metrics are different between the two systems
Time to reach −40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) were independent predictors for PVI achievement.

POLARx Comparative performance

Propensity Score-Matched Comparison

In a propensity score-matched comparison (covarying in age, gender, CHA2DS2VASc and left atrial dilation) between POLARx (PLX) and Arctic Front Advance Pro™ (AFA), POLARx demonstrated significantly lower procedure time and greater visualization of time-to-isolation.¹⁴

3 Centers

PLX vs AFA Pro

30 PLX patients
30 AFA patients

Objective:

Compare the procedural efficacy and biophysical parameters of POLARx and AFA-Pro as well as the 1-year outcomes.

Acute procedural results¹⁴

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

POLARx cryoablation system showed similar efficacy in vein occlusion, isolation and safety profile vs. Arctic Front cryoablation system.
Procedure time, fluoroscopy time, and cumulative freeze duration were significantly lower with POLARx cryoablation system.
POLARx showed a lower nadir temperature, faster time to -40°C, lower isolation temperature and longer thaw time.
There was no significant difference in isolation time between the two groups but electrical activity visualization enabling real time isolation was higher in POLARx than Arctic Front.

POLARx Comparative performance

Other comparative studies

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

POLARx meta-analyses

Updated systematic review and meta-analysis

A systematic review and meta-analysis, including a total of 8 studies with 1146 patients from 11 European centers confirms similar acute outcomes for POLARx (PLX) and Arctic Front Advance Pro™ (AFA Pro). This updated review, following an earlier publication in 2021, provides new safety data on minimal esophageal temperature and thromboembolic events.²⁵

11 Centers

8 Studies*

317 PLX patients
819 AFA Pro patients

Objective:

The goal of this updated comprehensive meta- analysis was to compare differences in acute outcome between POLARx and AFA-Pro in patients with AF undergoing PVI.

Acute procedural results²⁵

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

Other meta-analyses

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.

6. Heeger CH, Pott A, Sohns C, et al. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study. Europace. 2022 Dec 9;24(12):1917-25
(https://doi.org/10.1093/europace/euac148)

7. Spera F et al. Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation. Front. Cardiovasc. Med. 9:985182. 2022
(https://doi.org/10.3389/fcvm.2022.985182)

8. Fassini, et al., Novel cryoballoon technology for a successful pulmonary vein isolation: acute outcome and follow up from a large multicenter Italian clinical setting, Europace 2022,
(https://doi.org/10.1093/europace/euac053.217)

9. Iacopino, et al., Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry, J Interv Cardiovasc Electrophysiol. 2022,
(https://doi.org/10.1007/s10840-021-01063-2)

10. Martin A, et al., Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long‑term outcomes in a multicentre clinical study, J Interv Cardiovasc Electrophysiol. 2022,
(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)

13. Honarbakhsh S et al., Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience. EP Europace, Volume 25, Issue 11, November 2023, euad286,
(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)

21. Imnadze, et al., Two competing cryoballoon technologies for single shot pulmonary vein isolation: first experiences with the novel system, Rev. Cardiovasc. Med. 2022
(http://doi.org/10.31083/j.rcm2304118)

22. Tilz, et al., Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation – The Prospective ICE-AGE-X Study, Circ J. 2021,
(https://doi.org/10.1253/circj.cj-21-0094)

23. Creta, et al., First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison, J Cardiovasc Electrophysiol. 2021,
(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,
(https://doi.org/10.1016/j.ijcha.2022.101115)

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.
(https://www.mdpi.com/2077-0383/13/5/1259)

28. Liao Y, Bai R, Murthy S, Smith DJ, Ebady R, Shatz DY, Weiss JP, Zawaneh M, Tung R, Su W. Quantifying pulmonary vein antrum contact area with novel dual-sized cryoballoon to optimize pulmonary vein isolation. Heart Rhythm. 2024 Nov;21(11):2360-2361
(https://www.heartrhythmjournal.com/article/S1547-5271(24)02660-2/fulltext)

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Going beyond the conventional

On this page

Clinical Evidence

Read the POLARx Clinical Compendium

FROzEN-AF US IDE Clinical Trial

Objective:

Acute procedural results

Chronic safety and efficacy

Proof-of-Concept clinical trial

Objective:

Acute procedural results

POLAR ICE multicenter study

Objective:

Acute procedural results

Chronic safety and efficacy

ANTARCTICA observational study

Objective:

Acute procedural results

Chronic results

Other POLARx studies

Prospective ICE AGE 1 Study

Objective:

Acute procedural results¹²

Chronic efficacy¹²

UK comparative study

Objective:

Acute procedural results

Propensity Score-Matched Comparison

Objective:

Acute procedural results14

Other comparative studies

Updated systematic review and meta-analysis

Objective:

Acute procedural results25

Other meta-analyses

Acute procedural results¹⁴

Acute procedural results²⁵