POLARx™

Cryoablation System

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.

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FROzEN-AF US IDE Clinical Trial

In a global, prospective, single-arm study, researchers evaluated the safety and effectiveness of the POLARx™ Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF). At 12 months, data revealed a 96.0%^† freedom from primary safety events (100% for the POLARx™ FIT 12-month extension arm study) and a 79.9% freedom from atrial arrhythmias (82% in the FIT extension study). 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.¹

Mean ± SD
*Only ablations with duration >60S included in ablation counts

Twelve-month data on POLARx™ FIT showed low arrhythmia recurrence and freedom from primary safety events, with a high rate of Grade 3 or 4 occlusions achieved.¹

Freedom from atrial arrhythmias

at follow-up (12 months) after using POLARx FIT

Major adverse events

including esophageal fistulas, persistent phrenic nerve palsy and PV stenosis

High-grade occlusion rate

resulting in either Grade 3 or Grade 4 occlusion level

POLAR ICE multicenter study

In a prospective, nonrandomized 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.^2,3

Safety²

Procedural characteristics³

POLAR ICE study - Procedural characteristics chart

12-month efficacy²

Performance and biophysical characteristics³

POLAR ICE study - Performance and biophysical characteristics chart

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.⁴

Acute PV isolation

Real-time PVI visualization

Freedom from recurrence

at 226 ± 115 days

Performance vs. existing cyroablation systems

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™ and 102 consecutive patients previously treated with Arctic Front Advance Pro™, POLARx demonstrated comparable safety and efficacy with lower cryoballoon nadir temperatures and improved rates of real-time visualization of PVI.⁵

U.K. Comparative Study

A large United Kingdom multicenter study of 1,688 AF patients compared the POLARx™ Cryoablation System 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.⁶

Reported phrenic nerve palsy⁶

Complication rate⁶

Procedure time⁶

Review data from the study United Kingdom POLARx versus AFA experience

Propensity Score-Matched Comparison

In a propensity score-matched comparison (covarying in age, gender, CHA₂DS₂VASc and left atrial dilation) between POLARx™ and Arctic Front Advance Pro™, POLARx™ demonstrated significantly lower procedure time and greater visualization of time-to-isolation.⁷

Faster procedure time

vs. Arctic Front Advance
(61 min. vs. 73 min.)

Faster to -40˚C

vs. Arctic Front Advance
(30 sec. vs. 48 sec.)

Greater real-time isolation rate

vs. Arctic Front Advance
(84% vs. 70%)

Procedural characteristics

Studies comparing POLARx™ and other cryoablation systems

Multi-center	Single-center
Imnadze et al. (2022) >	Creta et al. (2021) >
Guckel et al. (2022) >	Kochi et al. (2021) >
Yap et al. (2021) >	Tilz et al. (2021) >
	Mojica et al. (2021) >

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References:

1. Ellenbogen KA, Mittal S, Varma N, et al. One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial. J Cardiovasc Electrophysiol. 2024 March 6. doi.org/10.1111/jce.16220
2. 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.
3. 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. doi: 10.1111/jce.15861. Epub 2023 Feb 23. PMID: 36786515.
4. 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
5. 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. doi: 10.1093/europace/euad248.
6. Honarbakhsh S, Martin CA, Mesquita J, et al. AF cryoablation is an effective day case treatment: The United Kingdom PolarX versus AFA experience. EP Europace. Sept 21, 2023. euad286. doi.org/10.1093/europace/euad286
7. 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.

† Updated analysis with corrected data.

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