7 Jul 2023 • Patients who require rhythmic assistance in two chambers of the heart now have the option of a leadless system, after the US Food and Drug Administration (FDA) approved AVEIR, a dual-chamber (DR) leadless pacemaker system. With more than 80% of people who need a pacemaker requiring pacing in two chambers of the heart (both the right atrium and right ventricle), the approval significantly increases access to leadless pacing for millions of people.

The AVEIR DR system is the first technology of its kind to consist of two pacemakers implanted directly into the heart myocardium without the need for leads. Traditional pacemakers require a more invasive procedure to install, and the limited lifespan of leads means that current systems last between 10 to 15 years.

Abbott’s two devices, each a little smaller than a AAA battery, communicate via the company’s proprietary i2i technology which uses high-frequency pulses to achieve synchronicity.

The FDA approval of the AVEIR DR dual chamber leadless pacemaker system comes on the heels of recent late-breaking clinical data published in The New England Journal of Medicine showing that AVEIR DR system met its three prespecified primary endpoints for safety and efficacy. Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study through three-months post-implant showed a 98.3% implant success rate for physicians and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.

Shorter, smaller and slimmer than a AAA battery, each AVEIR pacemaker is implanted via a minimally invasive procedure. The device attaches to the heart's interior surface with a screw-in mechanism – known as a helix – that allows for future retrieval of the device should therapy needs evolve, or if the device needs to be replaced in the future.

Source: Diagnostic & Interventional Cardiology | Read full story