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

GOING BEYOND THE CONVENTIONAL

POLARx™: Setting a new standard in cryoablation
CARDIAC MAPPING AND ABLATION THERAPIES
POLARxTM CRYOABLATION SYSTEM
POLARxTM IN DEPTH
CLINICAL EVIDENCE
CARDIAC MAPPING AND ABLATION THERAPIES
POLARxTM CRYOABLATION SYSTEM
POLARxTM IN DEPTH
CLINICAL EVIDENCE
Electrophysiology / Cardiac Mapping and Ablation Therapies / Single Shot / Clinical Evidence

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

POLARICE – 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)

  • Prospective
  • Non-randomized
  • Single-arm
  • 19 centers
  • 399 patients
POLARICE

Safety

3.3%

Primary Safety Event Rate

0

No Patients Suffered From:
Atrial Esophageal Fistula
Pulmonary Vein Stenosis



Procedural Characteristics

69.0

Mean Procedure Time (min)

47.3

Mean LA Dwell Time (min)

15.8

Mean Fluoroscopy Time (min)



Performance and Biophysical Characteristics

96.2%

Acute PVI

81.4%

Single Shot Success

1.3

Mean Cryoablations per PV

98.1%

Grade 3-4 Occlusion

-56.3

Mean Nadir Temp (°C)

50

Mean Time to Isolation (sec)



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.

Upcoming Results

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

Upcoming Results
Upcoming Results
Upcoming Results

CHARISMA – 10-Month Follow- Up Data

prospective , non randomize, 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

Upcoming Results

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.

Upcoming Results

Biophysical parameters to predict acute PVI

Honarbakhsh

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

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.

iacopino et al
iacopino et al

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

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.

iacopino et al
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Head-to-Head Data

 

 

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

Procedural Characteristics

Click below to access to the full papers
Yap et al. | Multicenter2Kochi et al. | Single Center3
Creta et al. | Single Center4Tilz et al. | Single Center
Mojica et al. | Single center6; Guckel et al | Multicenter7
Imnadze et al | Multicente8

1-year outcome – Knecht et al.
Upcoming Results

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 .

Upcoming Results

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

Upcoming Results
Two cardiac catheter devices.

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