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
Future mapping capability
FARAVIEW Software Module pending 510(k) clearance, not available for sale in the United States.
FARAPULSE PFA System
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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
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