Physician and patient discussing treatment with FARAPULSE PFA

Treatment with the FARAPULSE™ PFA System*

Is the FARAPULSE™ Pulsed Field Ablation System the right treatment for you?

There are different types of atrial fibrillation (AF) and different types of cardiac ablation. Your doctor will assess your case to determine if cardiac ablation with the FARAPULSE™ PFA System is an appropriate treatment for you. The assessment will consider the following:

Discover why FARAPULSE is right for you.

The FARAPULSE™ PFA System may be right for you if:

  • You suffer from paroxysmal AF (AF episodes come and go, often resolving without treatment)
  • You meet the criteria for a cardiac ablation procedure called pulmonary vein isolation (PVI)



Discover why FARAPULSE is wrong for you.

The FARAPULSE PFA System is not right for you if:

  • You suffer from persistent or permanent AF
  • You do not meet the criteria for a PVI cardiac ablation procedure

As with any medical procedure, there are risks involved with pulsed field ablation with the FARAPULSE™ PFA System. See the Important Safety Information below for a list of possible complications, and ask your specialist about the risks and benefits of the FARAPULSE™ PFA System.

If you are suitable for PVI, why consider the FARAPULSE™ PFA System?

more than 125K patients treated with FARAPULSE

> 125K PATIENTS TREATED WORLDWIDE1

FARAPULSE is a proven ablation technology.

PROVEN ABLATION TECHNOLOGY2-6

Patients have a fast recovery with FARAPULSE PFA system.

FAST RECOVERY7,8

FARAPULSE PFA system backed by 10 years of research.

BACKED BY 10 YEARS OF RESEARCH**,1-7 

Patients enjoy their life after being treated with FARAPULSE.

GIVES YOU YOUR LIFE BACK9


Pulsed field ablation (PFA) is the latest generation technology for cardiac ablation for the treatment of certain types of atrial fibrillation (AF).* The FARAPULSE™ System is the most widely used and comprehensively studied device for PFA – it’s been used to treat >125,000 patients and is backed by 10 years of research.1

In clinical studies, the FARAPULSE™ PFA System has shown long-lasting freedom from the impact of AF symptoms – comparable to those seen with thermal ablation technologies, but with minimal side-effects.2-8 In addition, because cardiac cells are more sensitive to the electrical field created by PFA than other tissue, structures close to the ablation site (such as the oesophagus or the phrenic nerve) are usually not impacted.2-6

FARAPULSE™ patients have reported fast recovery after their PFA procedure and no chest pain – a side-effect that can be experienced by patients treated with thermal ablation.7,8 

more than 125K patients treated with FARAPULSE.

>125,000 LIVES CHANGED.1 

Find a FARAPULSE™ PFA System treatment centre

How does it work?

With its distinctive flower design, the FARAPULSE™ PFA System is used for a cardiac ablation procedure called pulmonary vein isolation (PVI), during which non-thermal electrical impulses selectively target and neutralise the tissue where the pulmonary veins enter your heart. These entrances into the heart are often responsible for transmitting the abnormal electrical signals that disrupt the heart’s rhythm and cause AF. 

Treatment with FARAPULSE PFA - what to expect

Preparation and treatment processes will vary by country and individual hospital. Your doctor will give you more specific information regarding your treatment, but the following gives a general overview of what to expect. 

Meet Sofia

Sofia's diagnosis

The ablation procedure

Getting her life back 


This video is for informational purposes only and presents a fictive patient example to illustrate the ablation procedure. It does not constitute medical advice or guarantee specific outcomes. Individual results may vary. Boston Scientific strongly recommends consulting your physician for personalised medical guidance and to address any questions regarding your health or treatment options.

 Prior to the FARAPULSE PFA procedure

Ask questions to your doctor prior to the procedure.

TESTING

  • A routine blood test to check how healthy your kidneys are.
  • Studies or scans to gather up-to-date information on how your heart is behaving. These may include an echocardiogram, and/or a 3D scan of your heart using MRI (magnetic resonance imaging) or CT (computed tomography).
     

QUESTIONS

Use the time before the procedure to ask questions on anything you are unsure or nervous about. Download this list of questions that you can review to prepare for your appointments, with space to add points or queries of your own. 

Questions to ask your doctor

During the FARAPULSE™ PFA procedure

FARAPULSE is a proven ablation technology.

INTRAVENOUS (IV) LINE
You will have a small needle inserted into a vein in your arm to create access for a thin tube that will deliver into your body the medications required for the procedure.

ANAESTHESIA/SEDATION
The anaesthetist or sedation practitioner will give you the medication required for either the general anaesthetic or deep sedation and monitor you until they are sure you will not feel pain.

CATHETER ACCESS
Your specialist (cardiologist/electrophysiologist) will make a small cut in your groin through which a thin flexible tube called a catheter is inserted and gently guided up into your heart.

FARAPULSE™ PFA

  • The FARAPULSE™ System will be advanced through this first catheter with its "petals" straight until it is in the correct position in your heart.
  • Your specialist will open up the petals of the flower-shaped tip using different configurations to ensure only the problem zone (where the pulmonary veins enter the heart) is targeted. 
  • When the catheter is in the correct location, your specialist will deliver tiny microsecond electrical pulses through electrodes on the FARAPULSE™ catheter to neutralise the precise areas of tissue that cause AF. 
  • The ablation procedure will take approximately one hour.10
Download brochure

 After the FARAPULSE™ PFA procedure

What happens after a FARAPULSE PFA procedure.
  • Depending on what time of day you have your procedure and whether you have a general anaesthetic or sedation, you may be able to go home the same day or may need to spend a night in hospital. 
  • Your heart rhythm should be restored to normal, and you should start to feel better. 
  • There may be minor soreness or bruising in your groin where the catheter was inserted. 
  • You should be able to return to normal activities within a few days.
  • You will need to attend follow-up visits to monitor the healing of the groin and your heart rhythm. 
  • You should advise your doctor if any of your symptoms return or if you experience ongoing chest pain. 
View animation

What do doctors say about FARAPULSE™ PFA?

*Not all types of atrial fibrillation are suitable for treatment with cardiac ablation or with the FARAPULSE™ Pulsed Field Ablation System. Your doctor will be able to advise you if it could be a suitable treatment for you according to diagnostic and treatment guidelines.


REFERENCES: 

1. Data on file. Boston Scientific.
2. Reddy 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.
3. 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.
4. 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
5. 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
6. 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.
7. 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
8. Patient testimonials from FARAPULSE™ PFA WAVE DocuSeries​ Archives - Arrhythmia Academy
9. 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 Jul 2;84(1):61-74. 
https://doi.org/10.1016/j.jacc.2024.05.001
10. 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 Jul 4;25(7):euad185. doi: 10.1093/europace/euad185.


CAUTION:
This material is for informational purposes only and not meant for medical diagnosis. This information does not constitute medical or legal advice, and Boston Scientific makes no representation regarding the medical benefits included in this information. Boston Scientific strongly recommends that you consult with your physician on all matters pertaining to your health.  
 

FARAPULSE™ Pulsed Field Ablation System:
The FARAPULSE Pulsed Field Ablation (PFA) System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arrhythmia initiation or maintenance. With all medical procedures there are risks associated with the use of the device. The risks include but are not limited to pain or discomfort, electric shock, hypotension, infection/inflammation, allergic reaction, anesthesia risk, radiation injury/tissue burn, heart failure, renal failure, respiratory distress, arrhythmia, nerve injury (such as phrenic nerve or vagal nerve), gastrointestinal disorders, vessel trauma, cardiac trauma (such as perforation), injury related to adjacent structures (esophageal injury, atrio-esophageal fistula, pulmonary injury), pulmonary vein stenosis, surgical and access complications, muscle spasm, injury due to blood clot or air bubbles in the lungs or other organs, heart attack, TIA, stroke, and/or damage to red blood cells. In rare cases, cardiac arrest or death may occur. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation and use of the device.
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