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FARAPOINT™ Pulsed Field Ablation Catheter FDA APPROVED: See how it works

Wave pattern background for FARAPULSE PFA system

PFA Clinical data

NEW CLINICAL DATA:

FARAPULSE™ PFA vs thermal out to 4 years

Explore ADVENT LTO study results

The most proven PFA platform

The FARAPULSE™ 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

Explore our clinical data

Clinical data

ADVENT long-term outcomes study4

Products studied: FARAWAVE™​ 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.

Explore ADVENT LTO trial results

Real-world data

MANIFEST-US multicenter registry5

Products studied: FARAWAVE™​ PFA Catheter

MANIFEST-US is a retrospective observational study of post-approval use in the US of the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter focused on 30-day safety and procedural characteristics.

Explore MANIFEST-US registry results

Clinical data

ADVANTAGE AF US IDE trial (Phase I6, Phase II7), CTI sub-analysis8

Products studied: FARAWAVE™​ PFA Catheter, FARAPOINT™ 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 FARAPOINT™ Pulsed Field Ablation Catheter and continuous monitoring with the LUX-Dx™ Insertable Cardiac Monitor System for continuous heart rhythm monitoring.

The ADVANTAGE AF CTI sub-analysis compared the safety and effectiveness of the FARAPOINT™ PFA Catheter (Phase II) to radiofrequency ablation (RFA) (Phase I)—the standard of care—for adjunctive CTI ablation in PersAF patients.

Explore ADVANTAGE AF trial results

Clinical data

BEAT PAROX-AF20, BEAT PeRS-AF21 

Products studied: FARAWAVE™​ PFA Catheter

The BEAT PAROX-AF trial is a randomized controlled study designed to compare the efficacy and safety of FARAPULSE™ 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.

Explore published BEAT PAROX-AF trial results
Download BEAT PersAF Data Summary (PDF)

Clinical data

ADVENT IDE trial9, ADVENT AA burden sub-analysis10, ADVENT long-term outcomes study4

Products studied: FARAWAVE™​ PFA Catheter

The ADVENT IDE trial is the first randomized clinical trial that directly compared FARAPULSE™ PFA (with the FARAWAVE™ 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.

Explore ADVENT trial results

Clinical data

ADVANTAGE AF USE IDE trial (Phase I6, Phase II7), CTI sub-analysis8

Products studied: FARAWAVE™​ PFA Catheter, FARAPOINT™ 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 FARAPOINT™ Pulsed Field Ablation Catheter and continuous monitoring with the LUX-Dx™ Insertable Cardiac Monitor System for continuous heart rhythm monitoring.

The ADVANTAGE AF CTI sub-analysis compared the safety and effectiveness of the FARAPOINT™ PFA Catheter (Phase II) to radiofrequency ablation (RFA) (Phase I)—the standard of care—for adjunctive CTI ablation in PersAF patients.

Explore ADVANTAGE AF trial results

Clinical data

NAVIGATE-PF trial11

Products studied: FARAWAVE™​ NAV PFA Catheter, FARAVIEW™ Software Module

The NAVIGATE-PF clinical trial was a multi-center, first-in-human feasibility study that assessed the acute and chronic accuracy of FIELDTAG™ Technology on the FARAVIEW™ Software Module in visualizing pulsed field energy delivery by the FARAWAVE™ NAV Pulsed Field Ablation (PFA) Catheter. The study included two phases: Phase I (acute assessment) and Phase II (chronic assessment).

Download NAVIGATE-PF clinical data summary (PDF)

Clinical data

SINGLE SHOT CHAMPION trial12

Products studied: FARAWAVE™​ 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 Front™ cryoballoon ablation (CBA) to treat symptomatic, drug refractory paroxysmal atrial fibrillation (PAF) with continuous rhythm monitoring.

Explore SINGLE SHOT CHAMPION trial results

Real-world data

MANIFEST multicenter registries5,13

Products studied: FARAWAVE™​ PFA Catheter

The MANIFEST multicenter registries are retrospective observational studies of the real-world commercial use of the FARAWAVE™ Pulsed Field Ablation Catheter.

Explore MANIFEST registries results

Real-world data

Real-World Experience with the Pentaspline Pulsed Field Ablation System: One-Year Outcomes of the FARADISE Registry14

Products studied: FARAWAVE™​ 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.

Explore published FARADISE registry results
Download FARADISE registry infographic (PDF)

PRECLINICAL RESEARCH

Lead physician: Gerstenfeld E.

Comparison of Monopolar and Bipolar Pulsed Field vs Radiofrequency Ablation on Coronary Artery Injury in a Swine Model15

Products studied: FARAPOINT™​ 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.

Read the publication

Independent research

Lead physician: Chierchia G.

Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: A Periprocedural Clinical and Cost Analysis16

Products studied: FARAWAVE™​ 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.

Download data summary (PDF)

Independent research

Lead physician: Bisignani A.

National Workflow Experience with Pulsed Field Ablation for Atrial Fibrillation: Learning Curve, Efficiency, and Safety17

Products studied: FARAWAVE™​ 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.

Read the publication

Independent research

Lead physician: Della Roca D.G.

Pulsed Electric Field, Cryoballoon, and Radiofrequency for Paroxysmal Atrial Fibrillation Ablation: A Propensity Score-Matched Comparison18

Products studied: FARAWAVE™​ 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%).

Read the publication

Independent research

Lead physician: Chaumont C.

Pentaspline Pulsed Field Ablation Catheter Versus Cryoballoon for Atrial Fibrillation Ablation: Results From a Prospective Comparative Study19

Products studied: FARAWAVE™​ 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%).

Read the publication

*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.