A review of the extravascular implantable cardioverter-defibrillator system: technology, development, clinical outcomes, and global experience.

This article provides a comprehensive overview of the AuroraTM extravascular implantable cardioverter-defibrillator (EV-ICD) system for the treatment of potentially fatal ventricular arrhythmias. It details its hardware design, including the device and the lead, and examines software features such as antitachycardia pacing (ATP) and the suite of enhanced discriminators specifically designed to address potential sensing challenges with an anterior mediastinal lead. The report includes clinical data from the primary acute human studies, the Pivotal EV-ICD study, and the updated Enlighten Post-Approval Registry, highlighting safety and efficacy. The EV-ICD system represents a step toward minimizing transvenous lead-related complications while maintaining effective arrhythmia detection and therapy, offering a promising alternative for a broad spectrum of patients at risk of sudden cardiac death.