TCTMD announced that the U.S. Food and Drug Administration (FDA) has approved Boston Scientific’s pulsed-field ablation system, called Farapulse, for the treatment of patients with refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The Farapulse system is the second FDA-approved pulsed-field ablation system indicated for this patient population, following the approval of Medtronic’s PulseSelect system. Farapulse works by delivering high-power electrical pulses designed to puncture the cardiomyocytes’ cell membranes. In the pivotal ADVENT trial, researchers randomly assigned patients with paroxysmal atrial fibrillation to receive care with either the Farapulse system or thermal ablation. The system was noninferior to thermal ablation in terms of safety and efficacy after a follow-up of 1 year; Farapulse demonstrated shorter procedural duration but longer fluoroscopy duration compared with thermal ablation. The newly approved system may also be safer than radiofrequency or cryoballoon ablation by limiting damage to adjacent structures such as the esophagus and phrenic nerve. Additionally, real-world data showed that patients treated with Farapulse had a low rate of major complications and did not experience any phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury. The researchers plan to report further findings from ongoing trials evaluating the system in patients with paroxysmal atrial fibrillation.