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Abbott secures CE mark for dual-chamber leadless pacemaker

Abbott recently announced that it has received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.

The Aveir DR is the world’s first dual-chamber leadless pacemaker, designed to treat individuals with abnormal or slow heart rhythms. It enables wireless, beat-to-beat communication between two leadless pacemakers, with one pacing the right ventricle (Aveir VR) and the other pacing the right atrium (Aveir AR). Each device is approximately one-tenth the size of a traditional pacemaker, making them smaller than a AAA battery.

This system delivers electrical impulses directly to the heart muscle, restoring normal heart rhythm. Unlike traditional pacemakers, these leadless devices are inserted directly into the heart via a minimally invasive, catheter-based procedure, eliminating the need for cardiac leads and a subcutaneous pulse generator.

Using Abbott’s proprietary i2i (implant-to-implant) technology, the system provides synchronized pacing on every heartbeat according to the patient’s clinical needs. The i2i technology utilizes high-frequency pulses to transmit messages through the body’s blood, taking advantage of its naturally conductive properties, and requiring less battery power than inductive, radiofrequency, or Bluetooth communication.

In July 2023, Abbott announced it had received FDA approval for the dual-chamber pacemaker system, and the company completed the first U.S. commercial cases with Aveir DR in November.

 

© Abbott Laboratories

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