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.Talk to a FARAPULSE Education Specialist to find a doctor in your area
Get answers to your questions, prepare to talk with your doctor, and find a specialist who performs the FARAPULSE procedure.
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