† MAE data reflect outcomes from a real-world registry. SAE rate of 2.1% observed in the ADVENT Pivotal Trial evaluating the FARAPULSE™ Pulsed Field Ablation System. Source: Reddy, Vivek Y., et al. “Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation.” New England Journal of Medicine 389.18 (2023): 1660-1671.
References
- Ekanem E, Reddy VY, et al. Multi-National Survey on the Safety of the post-approval clinical use of Pulsed Field Ablation in 17,000 + patients (MANI FEST 17K)
*Defined as the occurrence of death, stroke, esophageal fistula or dysmotility, pulmonary vein stenosis, persistent phrenic nerve injury, pericardial tamponade, vascular complication, coronary artery spasm, hemolysis, or thrombosis - Piccini et al. Poster Presentation. HRS 2 025.
*Defined as the occurrence of all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention between device implantation and seven days or hospital discharge (whichever is later). Includes device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. - Wazni O, et al. New England Journal of Medicine, November 2024 . Primary Efficacy: Stroke, mortality, systemic embolism. Primary Safety: Non-procedural ISTH major and clinically-relevant non-major bleeding
- Eckart R, et al. Heart Rhythm O2. July 2025;In-Press:1-8. doi:10.1016/j.hroo.2025.07.014
- SK Doshi et al. Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation. New England Journal of Medicine, March 2026
CAUTION:
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