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FARAPULSE™

Pulsed Field Ablation System*

*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. Product not FDA approved. Not approved for sale in the US. For educational purposes only.
Farapulse clinical compendium
 

IMPULSE, PEFCAT, and PEFCAT II

Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II1

0%
AE Fistulas, Phrenic Nerve Damage, PV Stenosis1
96%
PVs isolated at ~3 months1
85 ± 5%
Kaplan-Meier estimated freedom from atrial arrhythmias at 1 year1
 

Acute isolation does not equal durable lesions; remapping data validates dose1

In three multi-center studies, the safety, PV isolation rate, and 1-year freedom from atrial arrhythmias was assessed.

  • There was no PV stenosis, persistent phrenic nerve damage, or AE fistulas.
  • With the optimized biphasic FARAPULSE waveform and workflow, there was a 96% PV isolation rate at ~3 months.
  • The KM estimate for freedom from atrial arrhythmias at one year was 85 ± 5%.
 

The 5S Study2

Objective

Studied the adoption and the process of streamlining ablation procedures with the FARAPULSE™ PFA System.

Methods

  • 191 patients: 62% paroxysmal and 38% persistent AF
  • 25 patient validation phase, 166 patient streamlined phase
  • Esophageal endoscopy was performed on 52 patients
  • Cerebral MRI was performed on 53 patients

Results

  • 100% acute PV isolation
  • 39 ± 14 min average procedure time
  • 9 ± 4 min average fluoroscopy time
  • During the streamline phase had a significantly shorter skin-to-skin procedure time
  • Low complication rates
  • 94.2% 6-month recurrence free-free rates (69 pts)
*Any symptomatic documented atrial tachyarrhythmia lasting >30 sec

0% thermal esophageal injury

No esophageal temperature rise

0% permanent phrenic nerve injury

0% pulmonary vein stenosis

Conclusions

  • This study documented the first 191 patients treated with the FARAPULSE PFA system in a single center with multiple operators.
  • The learning curve was short with significantly shorter procedure times in the streamlined phase, 38 ± 14 min.
  • The overall procedural complication rate was low and the incidence of asymptomatic cerebral lesions was similar to traditional modalities studied in the authors’ center.
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Multicenter Real-World Study3

Objective

Two high-volume centers assessed the efficacy and safety of FARAPULSE™ Pulsed Field Ablation in an early adopter setting inclusive of learning curve.

Methods

  • 138 atrial fibrillation (AF) patients (38% paroxysmal AF) underwent PVI

Results

 

Conclusions

In this real-world study, inclusive of learning curve, PVI with FARAWAVE Pulse Field Ablation resulted in:

  • A low rate of acute complications
  • A low rate of arrhythmia recurrence
  • Efficient and consistent LA dwell times
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