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The FARAPULSETM PFA Platform has built the largest and most comprehensive clinical evidence base in pulsed field ablation, with unmatched volume in peer-reviewed studies, registry participation, and patient outcomes across pivotal trials and real-world registries.*1-3
500K+
patients treated globally1
55+
clinical trials2
70K+
real-world registry patients3
Clinical data
Products studied: FARAWAVETM PFA Catheter
AVANT GUARD IDE is a randomized controlled IDE trial comparing FARAPULSE PFA with the FARAWAVE catheter to antiarrhythmic drug (AAD) therapy to assess the safety and effectiveness of first-line treatment for patients with persistent atrial fibrillation (persAF). The trial met its primary endpoints and demonstrated superiority over AAD therapy, adding to the extensive and rigorous clinical evidence supporting FARAPULSE PFA.
CAUTION: The FARAWAVETM Pulsed Field Ablation Catheter is not FDA approved as first line treatment for Persistent Atrial Fibrillation. It is being studied under an FDA Investigational Device Exemption for such use.
Can be accessed through NEJM: Wazni, et al. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation
Clinical data
Products studied: FARAFLEXTM Mapping and Pulsed Field Ablation Catheter
ELEVATE-PF is a first-in-human, single-arm, multicenter, prospective study assessing the safety and effectiveness of the FARAFLEXTM Mapping and Pulsed Field Ablation Catheter. The study was designed to optimize PFA dosing and workflow, with lesion durability evaluated at two months through mandated remapping. To date, 93 patients have completed remapping*; in the optimized cohort, pulmonary vein durability was 96.4% per vein and 85.3% per patient. One-year follow-up is ongoing.
*5 patients who underwent 1.4kV index ablation were excluded from the durability analysis
CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
Clinical data
Products studied: FARAWAVETM PFA Catheter
The ADVENT long-term outcomes (LTO) study—an observational extension of the pivotal ADVENT trial—assessed effectiveness of FARAPULSE PFA (with the FARAWAVE PFA Catheter) vs thermal (RF or cryo) ablation out to 4 years.
Real-world data
Products studied: FARAWAVETM PFA Catheter
MANIFEST-US is a retrospective observational study of post-approval use in the US of the FARAWAVETM Pulsed Field Ablation (PFA) Catheter focused on 30-day safety and procedural characteristics.
Clinical data
Products studied: FARAWAVETM PFA Catheter, FARAPOINTTM PFA Catheter
The ADVANTAGE AF US IDE Phase I clinical trial measured the safety and effectiveness of the FARAWAVE PFA Catheter for patients with drug refractory, symptomatic persistent atrial fibrillation.
The ADVANTAGE AF US IDE Phase II clinical trial included the addition of cavo-tricuspid isthmus isolation with the FARAPOINTTM Pulsed Field Ablation Catheter and continuous monitoring with the LUX-DxTM Insertable Cardiac Monitor System for continuous heart rhythm monitoring.
Clinical data
Products studied: FARAWAVETM PFA Catheter
AVANT GUARD IDE is a randomized controlled IDE trial comparing FARAPULSE PFA with the FARAWAVE catheter to antiarrhythmic drug (AAD) therapy to assess the safety and effectiveness of first-line treatment for patients with persistent atrial fibrillation (persAF). The trial met its primary endpoints and demonstrated superiority over AAD therapy, adding to the extensive and rigorous clinical evidence supporting FARAPULSE PFA.
CAUTION: The FARAWAVETM Pulsed Field Ablation Catheter is not FDA approved as first line treatment for Persistent Atrial Fibrillation. It is being studied under an FDA Investigational Device Exemption for such use.
Can be accessed through NEJM: Wazni, et al. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation
Clinical data
Products studied: FARAFLEXTM Mapping and Pulsed Field Ablation Catheter
ELEVATE-PF is a first-in-human, single-arm, multicenter, prospective study assessing the safety and effectiveness of the FARAFLEXTM Mapping and Pulsed Field Ablation Catheter. The study was designed to optimize PFA dosing and workflow, with lesion durability evaluated at two months through mandated remapping. To date, 93 patients have completed remapping*; in the optimized cohort, pulmonary vein durability was 96.4% per vein and 85.3% per patient. One-year follow-up is ongoing.
*5 patients who underwent 1.4kV index ablation were excluded from the durability analysis
CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
Clinical data
Products studied: FARAWAVETM PFA Catheter
The BEAT PAROX-AF trial is a randomized controlled study designed to compare the efficacy and safety of FARAPULSETM PFA to point-by-point RFA in patients with drug-resistant paroxysmal atrial fibrillation (AF).
The BEAT PersAF trial is a randomized, non-comparative trial evaluating the efficacy and safety of FARAPULSE PFA to treat drug-resistant persistent AF patients.
Clinical data
Products studied: FARAWAVETM PFA Catheter
The ADVENT IDE trial is the first randomized clinical trial that directly compared FARAPULSETM PFA (with the FARAWAVETM Pulsed Field Ablation (PFA) Catheter) to standard-of-care thermal ablation—radiofrequency ablation (RFA) and cryoballoon ablation (CBA)—for the treatment of paroxysmal atrial fibrillation (PAF).
The ADVENT trial: AA burden sub-analysis compared FARAPULSE PFA (with the FARAWAVE PFA Catheter) to standard-of-care thermal for recurrent atrial arrythmia (AA).
The ADVENT long-term outcomes (LTO) study—an observational extension of the pivotal ADVENT trial—assessed effectiveness of FARAPULSE PFA (with the FARAWAVE PFA Catheter) vs thermal (RF or cryo) ablation out to 4 years.
Clinical data
Products studied: FARAWAVETM PFA Catheter, FARAPOINTTM PFA Catheter
The ADVANTAGE AF US IDE Phase I clinical trial measured the safety and effectiveness of the FARAWAVE PFA Catheter for patients with drug refractory, symptomatic persistent atrial fibrillation.
The ADVANTAGE AF US IDE Phase II clinical trial included the addition of cavo-tricuspid isthmus isolation with the FARAPOINTTM Pulsed Field Ablation Catheter and continuous monitoring with the LUX-DxTM Insertable Cardiac Monitor System for continuous heart rhythm monitoring.
Clinical data
Products studied: FARAWAVETM NAV PFA Catheter, FARAVIEWTM Software Module
The NAVIGATE-PF clinical trial was a multi-center, first-in-human feasibility study that assessed the acute and chronic accuracy of FIELDTAGTM Technology on the FARAVIEWTM Software Module in visualizing pulsed field energy delivery by the FARAWAVETM NAV Pulsed Field Ablation (PFA) Catheter. The study included two phases: Phase I (acute assessment) and Phase II (chronic assessment).
Clinical data
Products studied: FARAWAVETM PFA Catheter
The SINGLE SHOT CHAMPION trial is the first randomized clinical trial that directly compared the safety and effectiveness of the FARAWAVE PFA Catheter versus Medtronic Arctic FrontTM cryoballoon ablation (CBA) to treat symptomatic, drug refractory paroxysmal atrial fibrillation (PAF) with continuous rhythm monitoring.
Real-world data
Products studied: FARAWAVETM PFA Catheter
The MANIFEST multicenter registries are retrospective observational studies of the real-world commercial use of the FARAWAVETM Pulsed Field Ablation Catheter.
Real-world data
Products studied: FARAWAVETM PFA Catheter
The FARADISE real-world registry (n=1158) underscores the safety and effectiveness of the FARAWAVE PFA Catheter, highlighting consistent results across ablation strategies and operator experience, with efficiency improving as experience grows.
PRECLINICAL RESEARCH
Products studied: FARAPOINTTM PFA Catheter
Read about a preclinical swine study of FARAPOINT PFA and RFA delivered near the coronary arteries without nitroglycerin. Both energies showed similar chronic coronary artery injury. Coronary artery spasm severity did not correlate with neointimal hyperplasia.
Independent research
Products studied: FARAWAVETM PFA Catheter
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.
Independent research
Products studied: FARAWAVETM PFA Catheter
In a national multicenter registry of over 650 AF ablation procedures, FARAPULSE PFA (with the FARAWAVE catheter) (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.
Independent research
Products studied: FARAWAVETM PFA Catheter
Read more about the first study showing a significantly lower PV reconnection in redo patients for FARAPULSE PFA (with the FARAWAVE catheter) (19.1%) than thermal, CBA (27.5%) or RFA (34.8%).
Independent research
Products studied: FARAWAVETM PFA Catheter
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%).
*Studied in over 70,700 patients
References
1. BSC data on file.
2. Listing of publications and clinical trials on file at BSC.
3. Additional publications by Turagam, Mohit., et al., Ekanem, Emmanuel, et al., Chaumont, Corentin, et al., Wong, Elisabeth, et al., Boersma, Lucas VA, et al., Mills, Mark T., et al., Bisignani, Antonio, et al.
4. Reddy, V. Y. (2026). Pulsed field versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nature Medicine. https://doi.org/10.1038/s41591-026-04246-4
5. Turagam, Mohit K., et al. "Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US." JACC (2025)
6. Reddy, V., Gerstenfeld, E., Schmidt, B., et al., Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. JACC. 2025 May, 85 (17)
7. Reddy, V., et al., "Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2."Circulation 151.0 (2025).
8. Gerstenfeld, E. P., et al. (2026). Pulsed field ablation versus standard radiofrequency ablation for typical atrial flutter: ADVANTAGE AF trial substudy. JACC: Clinical Electrophysiology.
9. 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
10. 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. 2024. 84(1): 61.74. https://doi.org/10.1016/j.jacc.2024.05.001
11. Reddy, V. et al. (2025). Visualization and chronic assessment of electrical field tags for pulsed field ablation of pulmonary veins with the second-generation pentaspline catheter. Presented at HRS 2025.
12. Reichlin, Tobias, et al. "Pulsed field or cryoballoon ablation for paroxysmal atrial fibrillation." New England Journal of Medicine 392.15 (2025): 1497-1507."
13. 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
14. Boersma, L., Széplaki, G., Dello Russo, A., et al., Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry, EP Europace, Volume 27, Issue 9, September 2025, euaf182, https://doi.org/10.1093/europace/euaf182
15. Gerstenfeld, E. P., et al. (2025). Comparison of monopolar and bipolar pulsed field vs radiofrequency ablation on coronary artery injury in a swine model. JACC: Clinical Electrophysiology. Advance online publication. doi/10.1016/j.jacep.2025.10.017
16. 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.
17. 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.
18. 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. https://doi.org/10.1093/europace/euae016
19. 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
20. Jaïs, P. et al., Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial, European Heart Journal, 2026.
21. Jaïs, P. et al., Pulsed field versus radiofrequency ablation for the treatment of persistent atrial fibrillation: The BEAT Pers‑AF trial. EHRA, April 14, 2026.
22. Wazni OM, Chun JKR, Nair DG, et al. (2026) Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation. N Engl J Med. Published online April 25, 2026. doi:10.1056/NEJMoa2600929
23. Reddy, V.Y., et al. (2026). ELEVATE PF: A First-In-Human Trial of a Novel Large Focal Map-And-Ablate PFA Catheter. Presented at HRS 2026.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.
This material not intended for use in France.
