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.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States, as reported previously by theheart.org | Medscape Cardiology. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the Heart Rhythm Society 2023 Scientific Sessions and in a simultaneous publication in the New England Journal of Medicine.
"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," co-author Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York City, said in the press release.
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