Aveir Right Atrial Leadless Pacemaker Model LSP201A - Intracardiac pacemaker

Intended purpose

The Aveir Right Atrial Leadless Pacemaker Model LSP201A 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 Right Atrial Leadless Pacemaker Model LSP201A 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).