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FARAPULSE™

Pulsed Field Ablation System

Transformative clinical leadership in PFA

Farapulse clinical brochure
Extensively researched and used in 125,000+ patients around the world, FARAPULSE™ Pulsed Field Ablation holds more published clinical evidence than any other pulsed field ablation (PFA) system. Global real-world experience includes multiple large-scale registries and robust clinical data from independent studies, with more trials underway.
Download FARAPULSE Clinical Data Brochure
 

Dedicated to transforming PFA

Since receiving CE mark in 2021 and FDA approval in 2024, more than 125,000 patients have been treated with FARAPULSE PFA. Along the way, we’ve continued to define, optimize, and validate pulsed field ablation therapy.
18 clinical trials
120 plus publications
More than 3 years of commercial use
 

Explore robust clinical data

Recurrent Atrial Arrhythmia Burden1, 2
ADVENT Pivotal Trial

FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation

The ADVENT Pivotal Trial sub-analysis compared FARAPULSE to standard-of-care thermal ablation (RFA and CBA) for recurrent Atrial Arrhythmia (AA). Patients treated with FARAPULSE showed a significantly greater reduction in AA Burden than thermal ablation.

Key Findings:

  • Significantly greater quality-of-life (QoL) improvements in patients with AA Burden <0.1% vs. ≥10%
  • Significantly lower risk for redo ablation, cardioversion, and hospitalization with AA Burden <0.1% vs. ≥0.1%
  • FARAPULSE patients were significantly more likely to have AA Burden <0.1% than RFA and CBA
Download ADVENT AA Burden Clinical Data Summary

ADVENT Pivotal Trial2

FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation

The first and only randomized clinical trial that directly compares PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA), for the treatment of paroxysmal atrial fibrillation (PAF)).

Key Findings:

  • The FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation
  • Met the primary safety and efficacy non-inferiority endpoints
  • PFA showed no instances of serious thermal complications
Download ADVENT Clinical Data Summary
 

MANIFEST-17K Multicenter Registry3

Major adverse event rates were less than one percent.

A retrospective observational study of the real-world commercial use of FARAPULSE PFA including data from 106 centers (91.4% of all commercial centers using FARAPULSE), 413 operators, and 17,642 patients.

Key Findings:

  • Major adverse event rates were low (<1%)
  • No reports of esophageal fistula, pulmonary vein stenosis or persistent phrenic nerve injury in the largest PFA registry to date
Download MANIFEST 17-K Clinical Data Summary

EU-PORIA4

Shorter procedure times

A multi-center registry studying the real-world adoption, workflow, acute and long-term outcomes after PFA in an all-comer atrial fibrillation (AF) patient population in high-volume European centers.

Key Findings:

  • Demonstrated rapid adoption of the technology by new operators and prior RF and cryo users
  • Operator experience and previous primary ablation modality did not have an effect on one-year recurrence rates
Download EU-PORIA Clinical Data Summary
 
 

Additional clinical data

Lead physician: Chierchia G

Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: A Periprocedural Clinical and Cost Analysis5

FARAPULSE (n=134) outperformed conventional cryoballoon ablation (CBA, n=135) in a 6-center randomized clinical trial. Compared to CBA, FARAPULSE had lower rates of complications, faster and more predictable procedures leading to reduced costs per patient at 30 days.
Download PERFECT-PAF Clinical Data Summary
 
Lead physician: Bisignani A

National Workflow Experience with Pulsed Field Ablation for Atrial Fibrillation: Learning Curve, Efficiency, and Safety6

Discover the difference with FARAPULSE! In a national multicenter registry of over 650 AF ablation procedures, FARAPULSE (n=348) consistently outperformed historical RFA/CBA (n=325) in predictability. Over 90% of FARAPULSE procedures were completed in under 90 minutes, compared to only 60% with RFA/CBA.
 
Lead physician: Della Rocca DG

Pulsed Electric Field, Cryoballoon, and Radiofrequency for Paroxysmal Atrial Fibrillation Ablation: A Propensity Score-Matched Comparison7

Read more about the first study showing a significantly lower PV reconnection in redo patients for FARAPULSE (19.1%) than thermal, CBA (27.5%) or RFA (34.8%).
 
Lead physician: Chaumont C

Pentaspline Pulsed Field Ablation Catheter Versus Cryoballoon for Atrial Fibrillation Ablation: Results From a Prospective Comparative Study8

See the data: one-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%).
 
Farapulse clinical compendium
 
 
FARAPULSE Pulsed Field Ablation System Indications, Safety and Warnings
 

References:

1. Reddy V, Mansour M, Calkins H. et al., Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. null2024, 0 (0). https://doi.org/10.1016/j.jacc.2024.05.001
2. Reddy VY, Gerstenfeld EP, Natale A, et al., Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Medicine.2023;Nov2;389(18):1660-1671. doi:10.1056/NEJMoa2307291
3. Ekanem, E., Neuzil, P., Reichlin, T. et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). https://doi.org/10.1038/s41591-024-03114-3
4. Schmidt B, Bordignon S, Neven K, et al., EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atrial fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023;25(7):euad185. doi:10.1093/europace/euad185
5. Chierchia G., et al. Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: A Periprocedural Clinical and Cost Analysis. ESC, Sept 2, 2024.
6. Bisignani, Antonio, et al. "National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety." Journal of Interventional Cardiac Electrophysiology (2024): 1-10.
7. Della Rocca DG, Marcon L, Magnocavallo M, et al., Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison, EP Europace, 2024;Jan26(1)euae016. doi.org/10.1093/europace/euae016
8. Chaumont C, Hayoun C, Savoure A, et al., Pentaspline pulsed field ablation catheter versus cryoballoon for atrial fibrillation ablation: results from a prospective comparative study. Journal of the American Heart Association. 2024;Mar12;0:e03314612 2024doi.org/10.1161/JAHA.123.033146

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