Skip to main content

FARAPULSE™

Pulsed Field Ablation System

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.
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 40,000+ 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
  • Future technology: Visualizing catheter placement with integrated mapping

Key Resources

Learn more about PFA Indications, Safety & Warnings Education and Training
REQUEST A SALES REP
icon-contact-email

Receive Product Updates

 icon_document.png

Clinical Compendium
 

Future mapping capability

FARAPULSE transformed the PFA landscape, and will continue transforming the industry with it's future mapping integration (anticipated approval 2024 2H). The magnetically-tracked PFA catheter (FARAWAVE™ NAV Pulsed Field Ablation Catheter) and integrated mapping module (FARAVIEW™ Software Module) will enable powerful, rapid visualization of the ablation area to monitor energy application and visually confirm your workflow.
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.
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.
VISUALIZE THE FUTURE
FARAWAVE NAV Pulsed Field Ablation Catheter CAUTION: lnvestigational Device. Limited by Federal (or US) law to investigational use only Not available for sale.
FARAVIEW Software Module pending 510(k) clearance, not available for sale in the United States.
 

FARAPULSE PFA System

 The FARAPULSE System is a complete PFA solution, evolving the standard of care for AFib with transformative technology.
 
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.
FARASTAR Pulsed Field Ablation Generator.
FARASTAR Pulsed Field Ablation Generator.
Delivers the proprietary bipolar and biphasic waveforms through the FARAWAVE™ Pulsed Field Ablation Catheter.
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
 

Transformative possibilities for AFib treatment

Tissue-selective ablation.

FARAPULSE restricts therapy to only the intended target.

  • FARAPULSE met all primary endpoints for safety and efficacy in the ADVENT Pivotal Trial1 (posterior probability >0.999)
  • In the MANIFEST-17K Multicenter Registry, more than 17,000 patients treated with FARAPULSE, reported no esophageal fistula, permanent phrenic nerve palsy, and pulmonary vein stenosis.2

Optimized through experience for lasting efficacy.

Our proven dosing strategy delivers durable lesions.

  • Delivers durable lesions via an 8-application workflow utilizing multiple distal shapes (flower and basket) in a single catheter
  • In a real-world propensity matched study, PV reconnection rate was significantly lower for FARAPULSE vs CBA and RFA.3

Transformative consistency and predictability.

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

  • EU-PORIA, a multicenter registry, demonstrated consistent procedure times, even among operators with varied experience.4
  • The ablation time is significantly lower for PFA, with an average reduction of 42% compared to thermal ablation.1
See the data
 
Dr. Joe Osorio.
 
Learn more at Farapulse university.
 
FARAPULSE Pulsed Field Ablation System Indications, Safety and Warnings
 

References:

*The VersaCross Connect Transseptal Dilator is for use with a 13F ID FARADRIVE Steerable Sheath which is 74cm in length, specifically, model: M004PF21M402 (USA).

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. Reddy VY, Ekanem E, et al., Multi-national survey on the safety of the post-approval clinical use of pulsed field ablation in 17,000+ patients. (MANIFEST-17K). AHA 2023.
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

Top