Treatment with the FARAPULSE™ PFA System*

Treatment with the FARAPULSE™ PFA System*

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

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. Their assessment will consider the following:

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)



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

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

~ 70K PATIENTS TREATED WORLDWIDE

 ~ 70K PATIENTS TREATED WORLDWIDE1

PROVEN ABLATION TECHNOLOGY

PROVEN ABLATION TECHNOLOGY2-6

FAST RECOVERY

FAST RECOVERY7,8

BACKED BY 10 YEARS OF RESEARCH

BACKED BY 10 YEARS OF RESEARCH**,1-7 

GIVES YOU YOUR LIFE BACK

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 ~70,000 patients1 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 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 

400 centres

TREATMENT WITH THE FARAPULSE™ PFA SYSTEM IS NOW OFFERED IN ABOUT 400 CENTRES IN EUROPE

~70,000 LIVES CHANGED

~70,000 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. 

 Prior to the FARAPULSE PFA 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.
  • Studies or scans to gather up-to-date information on how your heart is behaving. These may include an echocardiogram, an electrophysiology study 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

FASTING
You will be asked not to eat or drink anything after midnight the day before your procedure.

During the FARAPULSE™ PFA procedure

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 tissue (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 whole procedure will take approximately one hour. 
View animation

 After the 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 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. 
Download brochure

*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


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.