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Cardiologist in white coat shows AF patient a tablet, highlighting FARAPULSE™ PFA system.

FARAPULSE PULSED FIELD ABLATION (PFA) SYSTEM

Help your patients take control of their Atrial Fibrillation

As you know, Atrial Fibrillation (AF) is a growing problem

Heart with quick heartbeat tachycardia.

Atrial Fibrillation (AF) is the most common clinically significant cardiac rhythm disorder and may be considered a 21st century cardiovascular disease epidemic.Between 2008 and 2019, the proportion of deaths in Europe linked to AF rose by 50%, so by the end of that period, AF was responsible for approximately 14 deaths in every 1000.2 AF already accounts for up to 2.6% of healthcare spend in European countries3 and projections estimate that this debilitating disease will impact 17.9 million adults over the age of 55 years by 2060.4




2X RISK OF DEATH5




5X RISK OF STROKE5




3X RISK OF DEVELOPING HEART FAILURE5

Warning icon with magnifying glass showing people with AF face 2x higher risk of death.

2X RISK OF DEATH5

Brain icon with lightning bolt showing people with AF face 5x higher risk of stroke.

5X RISK OF STROKE5

Heart icon with waveform showing people with AF have 3x higher risk of developing heart failure.

3X RISK OF DEVELOPING HEART FAILURE5

The AF mortality risk rises dramatically over time if the condition is not appropriately treated.6

Warning icon with magnifying glass showing people with AF face 2x higher risk of death.

2X RISK OF DEATH5

Brain icon with lightning bolt showing people with AF face 5x higher risk of stroke.

5X RISK OF STROKE5

Heart icon with waveform showing people with AF have 3x higher risk of developing heart failure.

3X RISK OF DEVELOPING HEART FAILURE5

The AF mortality risk rises dramatically over time if the condition is not appropriately treated.6

People with AF face:

Warning icon with magnifying glass showing people with AF face 2x higher risk of death.

2X RISK OF DEATH5

Brain icon with lightning bolt showing people with AF face 5x higher risk of stroke.

5X RISK OF STROKE5

Heart icon with waveform showing people with AF have 3x higher risk of developing heart failure.

3X RISK OF DEVELOPING HEART FAILURE5

The AF mortality risk rises dramatically over time if the condition is not appropriately treated.6

Calendar icon showing 19.5% mortality risk within 1 year after AF diagnosis.

19.5% MORTALITY RISK ONE YEAR POST DIAGNOSIS6

Icon representing the rise in the cases
Calendar highlights 48.8% mortality risk within 5 years of atrial fibrillation diagnosis

48.8% MORTALITY RISK FIVE YEARS POST DIAGNOSIS6

You see first-hand the debilitating impact of Atrial Fibrillation (AF) on your patients’ wellbeing and quality of life and know the risks it carries. Rate control medications may help manage symptoms in some patients, but they do not prevent AF episodes or prevent disease progression.

In many cases, the antiarrhythmic drugs (AADs) used for rhythm control fail to control AF or their effectiveness declines over time,7 while the bleeding risk linked to oral anticoagulation (OAC) therapy is also an important consideration.

The longer paroxysmal AF is not adequately managed with medication, the greater the risk patients have it progressing to persistent or permanent forms.5,8

There is an alternative - a proven minimally invasive catheter procedure that treats the symptoms of AF and is now recommended by NICE as a treatment option for AF.9

Catheter ablation is recommended by the 2024 European Society of Cardiology (ESC) as a first-line treatment strategy for paroxysmal AF; catheter ablation is also advised for certain other AF patients.5

Different documents representing clinical data or research.

Multiple RCTs have provided evidence in favour of catheter ablation as a first-line approach for rhythm control in patients with paroxysmal AF, with a similar risk of adverse events as compared with initial AAD treatment.5

2024 ESC Guidelines for the Management of Atrial Fibrillation

FARAPULSE™ pulsed field ablation system

A new generation of catheter ablation technology for the treatment of Atrial Fibrillation that’s transforming safety outcomes and patients’ lives.

Hand holding #1 badge for world’s top doctor recommended pulsed field ablation procedure.

#1 DOCTOR-RECOMMENDED PULSED FIELD ABLATION (PFA) PROCEDURE WORLDWIDE10

Magnifying glass highlighting 10 years of research and analysis.

BACKED BY 10 YEARS OF RESEARCH…10-17

Documents with colored text and ">150," representing more than 150 publications.

… AND >150 PUBLICATIONS17

Hand holding #1 badge for world’s top doctor recommended pulsed field ablation procedure.

#1 DOCTOR-RECOMMENDED PULSED FIELD ABLATION (PFA) PROCEDURE WORLDWIDE9

Magnifying glass highlighting 10 years of research and analysis.

BACKED BY 10 YEARS OF RESEARCH…9-15,16

Documents with colored text and ">150," representing more than 150 publications.

… AND >150 PUBLICATIONS16

The AF mortality risk rises dramatically over time if the condition is not appropriately treated.6




#1 DOCTOR-RECOMMENDED PULSED FIELD ABLATION (PFA) PROCEDURE WORLDWIDE9





BACKED BY 10 YEARS OF RESEARCH…9-15,16




… AND >150 PUBLICATIONS16


Farapulse icon showing the number of patients treated

500,000

Patients treated with FARAPULSE

What do electrophysiologists say about FARAPULSE pulsed field ablation?

Icon showing double quotes

When you start a day and you see that several cases are planned with FARAPULSE, you feel relaxed upfront because of the intriguing safety profile of pulsed field ablation.

Professor Mattias Duytschaever. Electrophysiologist

What do patients say about FARAPULSE pulsed field ablation?

Icon showing double quotes

Since the operation, my quality of life is 9 out of 10. I am able to do the things I want to do…. It has massively changed my life.

Lucy, FARAPULSE Patient

Ready to talk to your patients about pulsed field ablation with FARAPULSE?


Which patients are suitable for catheter ablation?

Catheter ablation is recommended by the 2024 European Society of Cardiology (ESC) as a first-line treatment strategy for paroxysmal AF; catheter ablation is also advised for certain other AF patients.5

FIRST-LINE RHYTHM CONTROL THERAPY

Classa

Levelb

Catheter ablation is recommended as a first-line option with a shared decision-making rhythm control strategy in patients with paroxysmal AF (Atrial Fibrillation), to reduce symtoms, recurrence, and progression of AF.

1

A

AF PATIENTS RESISTANT OR INTOLERANT TO ANTIARRHYTHMIC DRUG THERAPY

Classa

Levelb

Catheter ablation is recommended in patients with paroxysmal or persistent AF resistant or intolerant to antiarrhythmic drug therapy to reduce symptoms, recurrence, and progression of AF.

1

A

PATIENTS WITH HEART FAILURE

Classa

Levelb

AF catheter ablation is recommended in patients with AF and HFrEF (Heart Failure with reduced Ejection Fraction) with high probability of tachycardia-induced cardiomyopathy to reverse left ventricular dysfunction.

1

B

 Table adapted from Recommendation Table 18, 2024 ESC Guidelines for the Management of Atrial Fibrillation.5

a Class of recommendation
b Level of evidence



REFERENCES:


1. Linz D, Gawalko M, Betz K, et al. Atrial fibrillation: epidemiology, screening and digital health. Lancet Reg Health Eur. 2024;1;37:100786. doi: 10.1016/j.lanepe.2023.100786.

2. Zuin M, Malagù M, Vitali F, et al. Trends in atrial fibrillation-related mortality in Europe, 2008–2019. Eur Heart J Qual Care Clin Outcomes. 2024;10(5):467-478. doi.org/10.1093/ehjqcco/qcae007

3. ESC press release available at: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Atrial-fibrillation-set-to-affect-more-than-14-million-over-65s-in-the-EU-by-2060. Last accessed May 2025.

4. Krijthe BP, Kunst A, Benjamin EJ. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J.2013; 34(35):2746-51. doi: 10.1093/eurheartj/eht280.

5. Van Gelder IC, Rienstra M, Bunting KV et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal (2024) 00, 1–101 https://doi.org/10.1093/eurheartj/ehae176.

6. Joglar JA, Chung MK, Armbruster AL et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149:e1–e156. doi: 10.1161/CIR.0000000000001193

7. Kheiri B, Simpson TF, Przybylowicz R, et al. Ablation Versus Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation: A Meta-Analysis of Randomized Trials. Circ Arrhythm Electrophysiol. 20217;14(8):e009692. doi: 10.1161/CIRCEP.120.009692.

8. Poole JE, Bahnson TD, Monahan KH et al. CABANA Investigators and ECG Rhythm Core Lab. Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial. J Am Coll Cardiol. 2020 Jun 30;75(25):3105–3118. doi: 0.1016/j.jacc.2020.04.065.

9. NICE guidance IPG806: Pulsed-field ablation for atrial fibrillation. Last accessed July 2025.

10. BSC data on file. 2025

11. Reddy VY, et al., Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II JACC: Clinical Electrophysiology 7.5 (2021): 614-627. doi:0.1016/j.jacep.2021.02.014

12. Schmidt B, Bordignon S, Tohoku S, et al. 5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. Circ Arrhythm Electrophysiol. 2022 Jun;15(6):e010817. doi: 10.1161/CIRCEP.121.010817.

13. Turagam MK, Neuzil P, Schmidt B, et al. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023;148:35–46. DOI: 10.1161/CIRCULATIONAHA.123.064959

14. 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). doi.org/10.1038/s41591-024-03114-3

15. Reddy VY, Gerstenfeld EP, et al; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.

16. Füting A, Neven K, Howel D et al. Patient discomfort following pulsed field ablation for paroxysmal atrial fibrillation – an assessment of chest and groin pain using the Numeric Rating Scale. Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

17. FARAPULSE Clinical Compendium.

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.