Abbott’s Aveir DR Dual-Chamber Leadless Pacemaker Approved by FDA

July 5, 2023—Abbott announced that the FDA has approved the Aveir dual-chamber (DR) leadless pacemaker system for the treatment of patients with abnormal or slow heart rhythms.

The Aveir DR leadless pacing system, which is approximately one-tenth the size of a traditional pacemaker, is composed of two devices: the previously approved Aveir VR single-chamber device, which paces the right ventricle, and the now-approved Aveir AR single-chamber device, which paces the right atrium.

According to the company, the Aveir pacemaker is implanted via a minimally invasive procedure. The device attaches to the heart’s interior surface with a helix that allows for future retrieval of the device if therapy needs to evolve or if the device needs to be replaced. Also, the Aveir DR system is designed to provide real-time pacing analysis, so physicians can assess the proper placement of the device during the procedure and before implanting the device into the inside of the heart chamber.

The Aveir DR device incorporates Abbott’s i2i communication technology to provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the patient’s clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker.

To support dual-chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication uses far less battery current than inductive, radio frequency or Bluetooth communication, noted Abbott.

“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” commented Vivek Y. Reddy, MD, in the company’s press release. “In delivering a true dual-chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and provided additional options to improve our ability to treat people with slow or abnormal heart rhythms.” Dr. Reddy is Director of Cardiac Arrhythmia Services for the Mount Sinai Hospital and the Mount Sinai Health System in New York, New York.

Abbott stated that findings from the AVEIR DR i2i investigational device exemption study showed that the Aveir DR system met its three prespecified primary endpoints for safety and efficacy. Through 3-months postimplantation, the study showed a 98.3% implantation success rate, and > 97% of patients had successful atrioventricular synchrony. The study was published in The New England Journal of Medicine (2023;388:2360-2370). Abbott announced the commencement of enrollment in the study in February 2022.