GOING BEYOND THE CONVENTIONAL POLARx: Setting a new standard in cryoablation

Going beyond the conventional

POLARx™: Setting a new standard in cryoablation

Clinical Evidence 

Discover results from POLARx™ clinical trials that highlight the benefits of a new cryoablation system

Safety & Efficacy outcomes  

​FROzEN-AF US IDE Clinical Trial

FROzen AF is 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). 385 patients were enrolled across 44 sites; 50 patients in the POLARx FIT arm.​

 

Procedural ​
Characteristic​
FROzEN-AF​
(28 mm balloon)​
POLARxᵀᴹ 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)​ 12.9 ± 11.2 min​ 7.2 ± 11.3 min​
Grade 3-4 Occlusion* (%)​ 95.9% (69.9% - Grade 4)​ 97.8% (67.3% / 80.8% - Grade 4)​
Single Shot Success* (%)​ 55.9%​ 35.3% / 62.1%​

*Only ablations with duration >60S included in ablation counts​

Outcomes from FROzEN-AF US IDE Trial​ ​ ​ ​ ​

The choice of balloon sizes (31 and 28 mm) with POLARx FIT may assist in overcoming challenges related to variability in patient PV size and geometry with the 31 mm balloon size.​


FROZEN AF (POLARx)​

*Safety: Including esophageal fistulas, persistent phrenic nerve palsy and PV stenosis​
** 28mm/31mm

Extended POLARx FIT arm​

  • Ellenbogen et al. One-Year Outcomes of Pulmonary Vein Isolation with a Novel Cryoballoon in 325 Patients: Primary Results of the FROzEN-AF Trial. HRS 2023. ​
  • 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.​

POLAR-ICE​

POLAR-ICE is a prospective, non-randomized, single-arm post-market study with 19 participating centers from 7 countries that enrolled 399 patients.​

POLAR-ICE – 399 AF patients AF registry

In a real-world setting, PVI with POLARx™ was safe, efficient and effective in experienced cryoballoon centers

OBJECTIVE
Provide real-world data on the use of the POLARx™ Cryoablation System for the treatment of atrial fibrillation

POLAR ICE (NCT04250714)


Acute Outcomes from POLAR ICE study​

Safety

3.3% :- Primary safety event rate | 0 :- Number of patients suffered from Atrial Esophageal Fistula  Pulmonary Vein Stenosis

Procedural characteristics

Procedural characteristics

Performance and Biophysical Characteristics

Performance and Biophysical Characteristics

Acute procedural characteristics, efficacy, and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR-ICE study, Tilz et al.

1-year outcomes from POLAR-ICE study​

Long-term outcomes for 399 patients with paroxysmal atrial fibrillation treated through PVI with POLARx Cryoablation Catheter demonstrated high effectiveness and safety.​
Lower nadir temperatures and a longer thawing time were predictors of clinical success.​

A Luik, oral presentation, ESC 2023 Amsterdam​

Two cardiac catheter devices.

1-year outcome – Yap et al.

Prospective cohort study, multicenter study, 110 consecutive patients who underwent first‐time cryoballoon ablation to compare the 1-year clinical outcome between POLARx and AFA-Pro (POLARx™: n = 57; AFA‐Pro™: n = 53).

Comparison of the 1‑year clinical outcome of a novel cryoballoon​ to an established cryoballoon technology, Yap et al

Two cardiac catheter devices.

CHARISMA – 10-Month Follow- Up Data

Prospective, non-randomized, multicenter Italian registry to assess safety and effectiveness of POLARx™ cyoablation system (112 patients, 439 PVs)

Novel cryo-balloon technology for a successful pulmonary vein isolation: acute outcome and follow-up from a large multicenter Italian clinical setting, Fassini et al

Two cardiac catheter devices.

12-Month Follow-Up Data – Martin et al.

Non-randomized, prospective, multicentre study enrolling 58 consecutive patients to evaluate the long-term safety and efficacy of this novel POLARx™ cyoablation system in treating Paroxismal AF. (58 patients, 231 PVs)

Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long‑term outcomes in a multicentre clinical study, Martin et al.

Two cardiac catheter devices.

ANTARTICA study - Christian-H Heeger et al.​

Multicenter assessment of efficacy and safety of the POLARx cryoablation system with a cohort of 317 patients treated for paroxysmal AF.​

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety ANTARCTICA study​ .


Procedural & Biophysical parameters

Two cardiac catheter devices.

Honarbakhsh et al.

Prospective, multi-centre study, included patients that underwent cryoablation for AF. Safety, efficacy, and cryoablation metrics were compared between PolarX and a propensity-matched AFA cohort

POLARx Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation, Honarbakhsh et al

Filename
Polarx-Cryo-Application.jpg
Size
102 KB
Format
image/jpeg
Download the infographic
iacopino et al

Iacopino et al.

Prospective, single-arm, multicenter study, first 69 patients treated with POLARx™ Cryoablation System. Procedural and acute data was collected on 247 PVs.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry, Iacopino et at.

Yap et al.

Prospective cohort study, multicenter study, 110 consecutive patients who underwent first‐time cryoballoon ablation (POLARx™: n = 57; AFA‐Pro™: n = 53).

Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience, Yap et al

Yap et al.
iacopino et al

Martin et al.

Prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 centers, between Aug 2020 and May 2021. This study included any patients indicated for treatment of PAF with the POLARx™ cryoablation system.

Biophysical Parameters and Time To Isolation of Pulmonary Veins with a Novel Cryoballoon: Results of POLAR ICE Study, Martin et al.

Comparative Performance


Single-center and multicenter published studies comparing POLARx™ to Artic Front Advance.

Procedural Characteristics

Click below to access the full papers

Two cardiac catheter devices.

CE mark data

Non-randomized, single-arm, prospective, multicenter study to assess safety and effectiveness of POLARxTM cryoablation system in patients undergoing PVI (n=30) for the treatment of paroxysmal AF.

Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience, Ante et al. Multicenter1

Two cardiac catheter devices.

1-year outcome – Knecht et al.

Non-randomized, prospective, multicentre study enrolling 80 consecutive patients to evaluate the long-term safety and efficacy of POLARx™ cyoablation system (40 patients) in comparision with AFA Pro™ cyoablation system in the tratment of paroxysmal atrial fibrillation

Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome, Knecht et al .

Two cardiac catheter devices.

Yap et al. - New meta analysis​

Multicenter assessment of efficacy and safety of the POLARx cryoablation system with a cohort of 317 patients treated for paroxysmal AF. Systematic review and meta-analysis comparing POLARx and AFA-Pro that provides new safety data on minimal esophageal temperature and thromboembolic events.

Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis​.

Read the POLARx Clinical Compendium

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

Filename
EP-1492804-AA-POLARx-Clinical-Compendium-digital-FINAL-3.pdf
Size
4 MB
Format
application/pdf
Download
Read the Clinical Compendium

Two cardiac catheter devices.

Arrhythmia therapy products

Our EP portfolio is at the leading edge of diagnosing and treating heart rhythm disorders. See the entire line.

Doctors with a tablet in the hands having a conversation and writing something on a writing pad.

Request a representative

Want to learn more about products and services? One of our sales representatives will be happy to contact you.


 

 

References

1. Anic et al. EP Europace, 2021.

2. Yap, S-C, Anic, A, Breskovic, T, 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; 32: 580– 587.

3. Kochi, AN, Moltrasio, M, Tundo, F, 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. 2021; 32: 588– 594.

4. Creta, A, Kanthasamy, V, Schilling, RJ, et al. First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison. J Cardiovasc Electrophysiol. 2021; 32: 925- 930.

5. Roland Richard Tilz, Roza Meyer-Saraei, Charlotte Eitel, Thomas Fink, Vanessa Sciacca, Lisbeth Delgado Lopez, Bettina Kirstein, Michael Schlüter, Julia Vogler, Karl-Heinz Kuck, Christian-H. Heeger, Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation ― The Prospective ICE-AGE-X Study ―, Circulation Journal, Article ID CJ-21-0094, Advance online publication April 13, 2021, Online ISSN 1347-4820, Print ISSN 1346-9843, https://doi.org/10.1253/circj.CJ-21-0094, https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-21-0094/_article/-char/en

6. De Asmundis et At. JAfib Jun-Jul 2021, Vol-14 Issue-1.

7. Guckel, D., Lucas, P., Isgandarova, K. 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 Interv Card Electrophysiol (2022). https://doi.org/10.1007/s10840-022-01279-w

8. Guram Imnadze, Thomas Fink, Mustapha El Hamriti, Leonard Bergau, Martin Braun, Moneeb Khalaph, Vanessa Sciacca, Khuraman Isgandarova, Denise Guckel, Christian Sohns, Philipp Sommer. Two competing cryoballoon technologies for single shot pulmonary vein isolation: first experiences with the novel system. Rev. Cardiovasc. Med. 2022, 23(4), 118.

CAUTION:

The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.

This material not intended for use in France.