> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Abbott Touts Data on Dual Chamber Pacemaker
- URL: https://www.fdaweb.com/abbott-touts-data-on-dual-chamber-pacemaker/
- Published: 2023-05-23T12:00:00.000Z
- Updated: 2026-09-14T18:33:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154518

Abbott reports new data from its AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study to assess what it describes as the world’s first dual-chamber leadless pacemaker, that met its three prespecified primary endpoints for safety and performance. The data have been submitted to FDA as part of the company’s PMA, according to the company.

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 synchronization of two leadless pacemakers has been a significant technological challenge, Abbott says.

"The vast majority of people needing a pacemaker require a dual-chamber pacemaker and would greatly benefit from a leadless device — but we’ve simply never had that option due to engineering challenges,” a company release says. The device was designed with a “first-of-its-kind i2i (implant-to-implant) technology,” Abbott says, “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.”

Additionally, the leadless device is designed with “attachment mechanisms” that allow retrieval of the pacemakers when changes in therapy are needed, Abbott says. It is also designed to provide real-time mapping capability so physicians can assess proper placement of the device before it is implanted, it adds.