FDA Approves First Leadless Dual-Chamber Pacing System

The US Food and Drug Administration (FDA) has approved "the world's first" leadless dual-chamber pacing system, one based in part on an already-approved leadless single-chamber device, Abbott has announced.

The company's AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.

The AVEIR DR system relies on proprietary wireless technology to provide bi-directional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.

The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient's pacing needs evolve or its battery needs replacing.

Source: MEDspace