Important Safety Information
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 procedure and use of the device.
FARAPULSE™ Pulsed Field Ablation is here.
Atrial fibrillation (AFib) doesn’t just disrupt the rhythm of your heart. It disrupts the rhythm of your life. It’s time to get back to the beat you were born with.
See if you may be a candidate for FARAPULSE.
125,000+
Over 125,000 people are already living the FARAPULSE PFA life.1 It’s the #1 doctor-recommended Pulsed Field Ablation (PFA) procedure worldwide.1
FARAPULSE™ PFA treats the source of AFib symptoms.2 Safely and effectively.3*
The first line of defense against AFib symptoms is usually medications like antiarrhythmics, but even when taking them, patients may continue to struggle with heart palpitations, shortness of breath or lightheadedness. Without proper treatment, AFib can progress, leading to serious complications like blood clots, stroke and heart failure. Studies have shown that early cardiac ablation in patients with paroxysmal AFib (occasional AFib) can reduce the risk of recurrence and lower the chances of heart failure or stroke compared to later intervention.4
94% of patients said they were satisfied with FARAPULSE PFA1
There are risks associated with all medical procedures. Talk to your doctor about the risks and benefits associated with the FARAPULSE™ Pulsed Field Ablation procedure.
FARAPULSE™ PFA is the next generation of cardiac ablation.
Catheter ablation has been done for over 20 years. Traditional methods use thermal ablation, or intensely hot or cold temperature energy to put the heart back in rhythm. The FARAPULSE procedure offers a new generation of ablation technology approved by the FDA that works differently by using pulses of electrical energy.
Traditional thermal cardiac ablation uses extreme heat or cold to create scar tissue that blocks signals causing abnormal rhythm, but has the potential to damage surrounding tissue in important areas.
FARAPULSE Pulsed Field Ablation uses short rapid pulses of energy to selectively target the area in the heart that causes an irregular heart rhythm, while preserving surrounding tissue.
Treating AFib with ablation has been shown to slow its progression.5
The FARAPULSE procedure is designed to turn disrupted into uninterrupted.
Over 73% of FARAPULSE PFA patients remained atrial arrhythmia free and off of heart rhythm medications at one year.6
In a clinical trial, 8 out of 10 people experienced no return of AFib symptoms within a year of the procedure.3*
FARAPULSE is the world’s most studied FDA-approved PFA procedure,1 with a less than 2.1% rate of complications.3
Most people who received the procedure stayed in the hospital for a day or less.3
If you’re still having symptoms on medications, talk to your doctor about the FARAPULSE procedure.
References:
1. BSC Data on file. 2024.
2. Reddy V, Lehmann JW, Gerstenfeld EP, et al. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm 2023;4(5):317-328. doi: 10.1016/j.hroo.2023.03.001
3. 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 May 18; 148:35–46.
4. Tennesen J, Ruwald MH, Pallisgaard J, Rasmussen PV, Johannessen A, Hansen J, et al. Lower recurrence rates of atrial fibrillation and MACE events after early compared to late ablation: a Danish nationwide register study. https://www.ahajournals.org/doi/10.1161/JAHA.123.032722
5. Kuck KH, Lebedev DS, Mikhaylov EN, Romanov A, Gellér L, Kalējs O, Neumann T, Davtyan K, On YK, Popov S, Bongiorni MG, Schlüter M, Willems S, Ouyang F. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. 2021 Mar ;23(3):362-369. doi: 10.1093/europace/euaa298. PMID: 33330909; PMCID: PMC7947582.
6. Reddy VY, Gerstenfeld EP, Natale A, et al., Pulsed field vs conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Medicine. 2023;Nov2;389(18):1660-1671. doi:10.1056/NEJMoa2307291.
* In a clinical trial 81.6% of people with paroxysmal AFib had no atrial fibrillation, atrial flutter, or atrial tachycardia after a single ablation procedure at 12 months.