The U.S. Food and Drug Administration (FDA) approved on July 5 the first-ever dual-chamber leadless pacemaker system (AVEIR DR), developed by Abbott, opening access to a new minimally invasive technology to treat patients with slow or abnormal heart rhythms.

Novel features of the pacemaker system include its implant-to-implant communication providing wireless synchronization, its small size – roughly the size of a AAA battery, and its helix design, allowing device retrieval should a patient’s needs change or the battery depletes.

The FDA handed down approval following the release of late-breaking clinical data presented during Heart Rhythm 2023 and simultaneously published in The New England Journal of Medicine, which reported a 98.3% implant success rate for physicians and more than 97% successful atrio-ventricular synchrony in patients, despite different types of underlying slow heart rhythms. Overall, the new system met all three of its prespecified primary endpoints for safety and efficacy.

For more information, access Abbott’s press release.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Physicians, Heart Ventricles, Arrhythmias, Cardiac, Pacemaker, Artificial, United States Food and Drug Administration, ACC Advocacy

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