Therapy Areas: Devices
Abbott announces late-breaking outcome from AVEIR DR i2i IDE study
22 May 2023 -

United States-based medical device and healthcare company Abbott Laboratories(NYSE: ABT) announced on Saturday its late-breaking outcome from the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study, a large-scale study to evaluate the world's first dual-chamber leadless pacemaker.

The study indicated that the leadless pacemaker met its three prespecified primary endpoints for safety and performance. The data further suggests that AVEIR DR could offer new benefits for people with slower-than-normal heart rhythms.

The outcome was revealed during a late-breaking clinical trial session at the Heart Rhythm Society's (HRS) 44th annual meeting in New Orleans and simultaneously published in The New England Journal of Medicine. The company has submitted this data to the US Food and Drug Administration (FDA) as part of its submission for approval of the AVEIR DR device.

Abbott designed the AVEIR DR leadless pacemaker – the DR denoting dual-chamber rate response – with a first-of-its-kind i2i (implant-to-implant) technology, with the goal of providing beat-to-beat communication and synchrony between two leadless pacemakers, a necessary foundation of dual-chamber leadless pacing therapy. Unlike other leadless pacemakers, this system allows the two devices to communicate with each other -- sensing for delayed or missed heartbeat and then pacing the appropriate chamber of the heart.