Late-breaking results from the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study, a large-scale study to assess Abbott’s Aveir dual-chamber leadless pacemaker, have been presented at the Heart Rhythm Society’s 2023 annual meeting (19–21 May, New Orleans, USA) and simultaneously published in The New England Journal of Medicine (NEJM).
The leadless pacemaker met its three pre-specified primary endpoints for safety and performance. The data has been provided to the US Food and Drug Administration (FDA) as part of Abbott’s submission for approval of the Aveir DR device.
Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.
While many people require pacing and sensing in both the right atrium and the right ventricle, currently available leadless pacing options have been limited to single-chamber ventricular devices because seamless, wireless synchronisation of two leadless pacemakers has been a significant technological challenge.
“The vast majority of people needing a pacemaker require a dual-chamber pacemaker and would greatly benefit from a leadless device—but we have simply never had that option due to engineering challenges,” said Reinoud E Knops (Amsterdam University Medical Center, Amsterdam The Netherlands) co-principal investigator of the AVEIR DR i2i IDE study. “Data from the AVEIR DR i2i study show that Abbott has designed a groundbreaking technology for seamless communication between two leadless pacemakers, and that Aveir DR can deliver appropriate therapy safely, opening up a future treatment option for more people with abnormal heart rhythms.”