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FARAPULSE™

Pulsed Field Ablation System

FARAPULSE catheter in variable distal shapes of basket and flower.
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FARAPULSE Pulsed Field Ablation video.
FARAPULSE Pulsed Field Ablation (PFA) procedure showing catheter in basket shape.
FARAPULSE Pulsed Field Ablation System, including FARAWAVE PFA Catheter and FARASTAR PFA Generator.
FARAPULSE catheter in variable distal shapes of basket and flower.
play icon
FARAPULSE Pulsed Field Ablation video.
FARAPULSE Pulsed Field Ablation (PFA) procedure showing catheter in basket shape.
FARAPULSE Pulsed Field Ablation System, including FARAWAVE PFA Catheter and FARASTAR PFA Generator.
Transformative experience for PFA
FARAPULSE Pulsed Field Ablation System Animation
FARAWAVE™ Pulsed Field Ablation Catheter
FARAPULSE™ Pulsed Field Ablation System

FARAPULSE™ Pulsed Field Ablation System, the world's clinical leader in PFA used in 125,000+ patients, is transforming treatment for atrial fibrillation by:

  • Selectively ablating myocardium to reduce risk of damage to surrounding tissue
  • Delivering durable transmural pulmonary vein (PV) lesions to limit redo procedures for PV triggers
  • Adapting to variable patient PV anatomy for reproducible procedures and limiting left atrium (LA) dwell time
  • Creating workflow efficiencies to simplify the procedure and shorten the learning curve
  • Visualizing workflow with integrated mapping and a magnetically-tracked catheter

Key Resources

Learn more about PFA Indications, Safety & Warnings Education and Training
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Clinical Compendium

Transformative possibilities for AFib treatment

Tissue-selective ablation

Farapulse system overview

FARAPULSE restricts therapy to only the intended target.

  • ADVENT Pivotal Trial: FARAPULSE met all primary endpoints for safety and efficacy1 (posterior probability >0.999)
  • MANIFEST-17K Registry (17,000+ pts): no reported esophageal fistula, permanent phrenic nerve palsy, and pulmonary vein stenosis.2

Optimized for efficacy

Farapulse system overview

FARAPULSE offers a proven dosing strategy that delivers durable lesions.

  • Delivers durable lesions via streamlined workflow using multiple distal shapes in a single catheter
  • Propensity-Matched Study: PV reconnection rate significantly lower for FARAPULSE vs. CBA and RFA.3

Rapid and reproducible

Farapulse system overview

The FARAPULSE workflow is rapid and reproducible, while reducing procedural duration variability.

  • EU-PORIA Multicenter Registry: consistent FARAPULSE procedure times, even among operators with varied experience.4
  • PFA ablation time significantly lower, with an average reduction of 42% vs. thermal ablation.1
See the data
 

Mapping experience

Farapulse system overview

FARAPULSE innovation continues with the mapping integration of the FARAVIEW™ Software Module and the FARAWAVE™ NAV Pulsed Field Ablation Catheter.

Together, they allow operators to confirm ablation success while maintaining worfklow simplicity. FARAVIEW is available exclusively on the OPAL HDx™ Mapping System.

Visualize the future
 

System components

The FARAPULSE System is a complete PFA solution, evolving the standard of care for AFib with transformative technology.
Computer cart displaying FARAVIEW Software Module interface on grayscale wave pattern
FARAWAVE Pulsed Field Ablation Catheter.
An integrated mapping module used to visualize the placement, shape, rotation, field application and more of the FARAWAVE NAV catheter.
FARASTAR Pulsed Field Ablation Generator.
FARASTAR Pulsed Field Ablation Generator.
Delivers the proprietary bipolar and biphasic waveforms through the FARAWAVE™ Pulsed Field Ablation Catheter.
Dynamic hero image of FARAWAVE NAV PFA catheter in flower pose on grayscale wave pattern
FARAWAVE Pulsed Field Ablation Catheter.
An over-the-wire catheter that includes magnetic tracking in addition to the advanced capability of the original FARAWAVE catheter.
FARAWAVE Pulsed Field Ablation Catheter in variable distal shapes of basket and flower, and FARADRIVE Steerable Sheath.
FARAWAVE Pulsed Field Ablation Catheter.
An over-the-wire catheter with variable distal shapes (basket and flower) to successfully ablate the pulmonary vein in a wide range of unique patient anatomies.
FARADRIVE Steerable Sheath.
FARADRIVE Steerable Sheath.
A 16.8F steerable sheath designed specifically for maneuvering the FARAWAVE PFA Catheter.
VersaCross Connect Access Solution.
Versacross Connect Access Solution for FARADRIVE.
Connects VersaCross™ technology with the FARADRIVE Steerable Sheath* for an integrated ZERO EXCHANGE left heart access workflow.
Explore VersaCross Connect >
 
Download spec sheet
 
 
 
 
Dr. Joe Osorio.
 
Learn more at Farapulse university.
 
FARAPULSE Pulsed Field Ablation System Indications, Safety and Warnings
OPAL HDx™ Mapping System Indications, Safety and Warnings
 
*The VersaCross Connect Transseptal Dilator is for use with a 13F ID FARADRIVE Steerable Sheath which is 74cm in length, specifically, model: M004PF21M402 (USA).

References:

1. 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
2. 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
3. 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
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

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