Aveir DR Dual-Chamber Leadless Pacemaker Wins FDA Approval

The US Food and Drug Administration has approved a dual-chamber leadless pacemaker system with implant-to-implant communication, according to Abbott.

The Aveir DR consists of two devices, one that is implanted percutaneously in the right atrium and one in the right ventricle. In the Aveir DR i2i study, published recently in the New England Journal of Medicine, the procedural success rate was 98.3%. The system met its primary safety endpoint and provided adequate atrial capture threshold and sensing amplitude at 90 days in the 300-patient study, with 97% of patients achieving at least 70% atrioventricular synchrony.

The conductive communication uses less battery current than the inductive, radiofrequency, or Bluetooth communications used by traditional pacemakers, its manufacturer says. The leadless pacemakers also are roughly one-tenth the size of a traditional device.

“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,” the Abbott press release states. “The Aveir DR system is also designed to provide real-time pacing analysis, so physicians can assess proper placement of the device during the procedure and before implanting the device to the inside of the heart chamber.”