Device Dossier
AVEIR AR 2 Right Atrial Leadless Pacemaker Model LSP203A - Intracardiac pacemaker
Device Dossier for AVEIR AR 2 Right Atrial Leadless Pacemaker Model LSP203A - Intracardiac pacemaker (Intracardiac pacemaker, Class III, sponsor Abbott…
- GMDN category: Intracardiac pacemaker
Intended purpose
The AVEIR AR 2 Right Atrial Leadless Pacemaker (LP) Model LSP203A is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes, for implantation in the right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual chamber pacing therapy.
Functional description
The AVEIR AR 2 Right Atrial Leadless Pacemaker Model LSP203A provides bradycardia pacing as a pulse generator for implantation in the right atrium. As a leadless pacemaker device, it does not need a pacing lead. The device has a docking button for delivery to or retrieval from the right atrium of the heart by using the Aveir Delivery Catheter and Aveir Introducer (to deliver) or Aveir Retrieval Catheter (to retrieve).