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FARAPULSE™ Pulsed Field Ablation System

FARAPULSE PFA system has been validated over 10 years through multiple pre-clinical and clinical trials

Featured clinical studies

Single Shot Champion Trial Results

single shot champion
Read more about the Single Shot Champion Trial

Reichlin, Tobias, et al. (in press). “Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation.” New England Journal of Medicine.

ADVANTAGE AF Clinical Trial Results

optimised treatment outcome.
Read More about ADVANTAGE AF Clinical Trial Results

Reddy, et al., Safety and Efficacy of Pulsed Field Ablation for Persistent Atrial Fibrillation: One-Year Results of ADVANTAGE AF. AF Symposium 2025, Boston, MA.

ADVANTAGE AF (Phase II) Trial Results

ADVANTAGE AF (Phase II) Trial Results
Read more about the Advantage AF (Phase II) Trial

Reddy, Vivek, et al. (in press). “Pulsed Field of Persistent Atrial Fibrillation with Continuous ECG Monitoring Follow-Up.” Circulation.

Watch Dr Vivek Y. Reddy discuss the randomised ADVENT Pivotal Trial results – PFA Vs Thermal Ablation

Review the findings and the outcome results at 1 year from the multi-national study on the methods, efficacy and safety of Pulsed Field Ablation (PFA) in a real-world setting.

Explore more about ADVENT

Recurrent Atrial Arrhythmia Burden1 ADVENT Pivotal Trial

optimised treatment outcome.
Read more about ADVENT AA Burden Results

Reddy, Vivek Y., et al. "Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Med;,me389.18 (2023): 1660-1671.

Read about MANIFEST-17K Registry Results 

optimised treatment outcome.
Read more about MANIFEST-17K Registry Results

Reddy & Ekanem, 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.

MANIFEST – PF Registry 1-yr outcomes

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

optimised treatment outcome.
Read about MANIFEST-PF Registry 1-yr outcomes

Turagam et al. “Safety and Effectivenes of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry”. Circulation AHA (2023)

Real-World: MANIFEST-PF

Real-world acute data from over 1700 patients.

optimised treatment outcome.
Read about MANIFEST-EP on EP Europace

Ekanem, Emmanuel, et al. “Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).” Europace (2022).

EU-PORIA Registry

The EU-PORIA Registry demonstrates a high single-procedure success rate and high procedure reproducibility in 1233 patients enrolled across 7 centres.

optimised treatment outcome.
Read about EU-PORIA Registry

Schmidt 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)

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single Centre Experience

optimised treatment outcome.
Read more

Lee et al. “Pulsed FieldAblation of Atrial Fibrillation:An Initial Australian Single Centre Experience”. Heart, Lung and Circulation (2024)

Validated nonthermal ablation for durable pulmonary vein lesions

Lesion Formation in Cardiac Pulsed-Field Ablation: Acute to Chronic Cellular Level Changes

Read More

Garrott, et al. Lesion Formation in Cardiac Pulsed-Field Ablation: Acute to Chronic Cellular Level Changes. Pacing and Clinical Electrophysiology, 2025, 00:1-11.

Coronary Spasm Due to Pulsed Field Ablation: A State-of-the-Art Review

optimised treatment outcome.
Read More

Ramirez, et al. Coronary Spasm Due to Pulsed Field Ablation: A State-of-the-art Review. Pacing and Clinical Electrophysiology, 2024, 0:1-9.

All clinical studies

Illustration showing post-pfa mapping.

Journal article

Real-world: 5S study

Real-world assessment of technology adoption/learning curve.

graph image quantitative vs qualitative analysis

Journal article

Safety: PV stenosis

No measured ostial narrowing or stenosis.

safety oesophagus graphical image

Journal article

Safety: oesophagus

No detected acute or chronic oesophageal lesions.

safety oesophagus graphical image

Journal article

Safety and efficacy

IMPULSE, PEFCAT and PEFCAT II: 85 ± 5% freedom from atrial arrythmias*.

graphically representation with graph.

Journal article

Lesion characterisation

PFA created antral lesions as encompassing as thermal ablation modalities.

graphically representation with graph.

Journal article

Left atrial structural mechanics

Preserved left atrial tissue compliance suggested less fibrotic healing.

image representaton of ablation.

Journal article

First-In-human trials

IMPULSE and PEFCAT safety and efficacy.

Antral PFA lesions persisted at 3-month remapping.

Journal article

Lesion durability

Antral PFA lesions persisted at 3-month remapping.

Ultra-rapid, tissue-selective ablation: both epicardial and endocardial.

Journal article

First-In-human feasibility

Tissue-selective ablation: both epicardial and endocardial.

Pulsed Field Ablation Versus Radiofrequency Ablation

Journal article

Pulsed field ablation versus radiofrequency ablation

Pulsed field ablation (PFA) can be myocardium selective sparing the esophagus during ablation.

human heart image.

Journal article

Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation

In this preclinical study, Endocardial PFA can be focally delivered to create homogeneous, myocardium specific lesions.

human heart image.

Journal article

Preclinical evaluation of pulsed field ablation

First-in-human endocardial PFA studies: PFA-based pulmonary vein and SVC isolation with demonstrable sparing of nerves and venous tissue.

Illustration showing post-pfa mapping.

Journal article

Pulsed field ablation for pulmonary vein isolation in atrial fibrillation

PFA preferentially affected myocardial tissue, allowing facile PV isolation.

pdf thumbnail picture of farapulse device

Read the clinical compendium

Access all clinical-study data for FARAPULSE PFA system in one place.

Download the clinical compendium

Case studies, reports, and presentations

Stay current with the latest findings and best practices for pulsed field ablation, available anytime through our convenient EDUCARE learning platform.

Explore EDUCARE training
Three scientists in lab gear, with one looking through a large microscope.

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Indications, safety and warnings
FARAWAVETM Pulsed Field Ablation Catheter
FARASTARTM Pulsed Field Ablation Generator
FARADRIVETM Steerable Sheath

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Approved intended use of device may differ for countries with applicable health authority registrations. Always refer to the product labelling for full instructions.

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

Bench Test or pre-clinical study results may not necessarily be indicative of clinical performance.

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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.

Bench Test results may not necessarily be indicative of clinical performance. Results from different clinical investigations are not directly comparable. Information provided for educational purposes only. Results from clinical studies are not predicative of results in other studies. Results in other studies may vary.

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Videos provided are meant for informational purposes only and may not be indicative of actual size or clinical outcome. The opinions, procedures and patient care policies expressed or depicted in this video are those of the physician and do not necessarily reflect the opinions, policies or recommendations of Boston Scientific Corporation or any of its employees. For further information and detailed instructions regarding the use of the Boston Scientific products featured in this video, please refer to the directions for use included within the Boston Scientific product package.

CAUTION: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com.