POLARx™

Cryoablation System

Engineered to enhance capabilities in pulmonary vein (PV) occlusion and ablation delivery, the POLARx™ Cryoablation System, featuring the dual-diameter POLARx™ cryoballoon catheter, redefines what's possible in cardiac cryoablation.

The POLARx™ Cryoablation System is designed to enhance capabilities in cryoablation for atrial fibrillation. With an ultra-maneuverable catheter sheath, intuitive console and a dual-diameter cryoballoon that inflates predictably to 31 mm at the push of a button, POLARx™ offers improvements across the cryoablation workflow to deliver safe and effective treatment.

Key features and technical specifications

Enhanced operator control.

Empowered by a full suite of accessory tools, the SMARTFREEZETM Console enables the personalization of procedure settings, monitoring notifications, and ablation times by the user.
The console supports CIRCA-S, single sensor esophageal probes, LS PRO integration, and a diaphragmatic movement sensor for monitoring during phrenic nerve pacing.

Streamlined workflow integration.

Automatic data logging reduces the burden of manual procedure documentation, freeing up lab staff and leading to potential cost and time savings during and after the procedure [1].
Easy ablation report exporting/printing streamlines accurate documentation of relevant data.

SAFETY
No Reported: PV Stenosis | Persistent Phrenic Nerve Palsy | Esophageal Fistulas [2,3]
EFFICACY
Freedom of Atrial Arrhythmias [2,3,4,5,6].
EFFICIENCY
Real-World Outcomes. POLAR-ICE Acute Results [7].

Specifications

[1] Kuck K, Fürnkranz A, Chun KRJ, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Euro Heart J. 2016 Oct;37(38):2858-65.

[2] Ellenbogen, et al. One-year outcomes of pulmonary vein isolation with a novel cryoballoon in 325 patients: primary results of the FROzEN-AF trial. Presented at: Heart Rhythm Society 2023; May 19-21, 2023; New Orleans, LA, USA.

[3] Su, et al. Clinical application of a novel 31 mm cryoballoon for pulmonary vein isolation for paroxysmal atrial fibrillation: procedural data from the FIT arm of FROzEN-AF. Presented at: Heart Rhythm Society 2023; May 19-21, 2023; New Orleans, LA, USA.

[4] Heeger CH, Pott A, Sohns C, Riesinger L, Sommer P, Gasperetti A, Tondo C, Fassini G, Moser F, Lucas P, Weinmann K, Bohnen JE, Dahme T, Rillig A, Kuck KH, Wakili R, Metzner A, Tilz RR. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study. Europace. 2022 Dec 9;24(12):1917-1925. doi: 10.1093/europace/ euac148. PMID: 36026521; PMCID: PMC9733956.

[5] Fassini, G. M., et al. "Novel cryo-balloon technology for a successful pulmonary vein isolation: acute outcome and follow-up from a large multicenter Italian clinical setting." Europace 24.Supplement_1 (2022): euac053-217.

[6] Yap SC, Anic A, Breskovic T, Haas A, Bhagwandien RE, Jurisic Z, Szili-Torok T, Luik A. 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 Mar;32(3):580-587. doi: 10.1111/jce.14915. Epub 2021 Feb 1. PMID: 33492749; PMCID: PMC7986676.

[7] Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. 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.