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FDA Approves Abbott's Dual Chamber Leadless Pacemaker: A Breakthrough in Cardiac Care

Abbott has introduced an innovative breakthrough in medical technology with the world's first dual-chamber leadless pacemakers. This groundbreaking development enables wireless communication and synchronization between the two pacemakers, which are smaller in size than an AAA battery.

Leadless pacemakers offer a minimally invasive alternative for patients in the United States who require pacing to address various slow or abnormal heart rhythms. The recent approval from the U.S. Food and Drug Administration (FDA) for Abbott's AVEIR™ DR leadless pacemaker system comes on the heels of compelling clinical trial data demonstrating its safety and effectiveness in treating abnormal heart rhythms.

The AVEIR DR devices utilize Abbott's proprietary i2i™ communication technology to provide synchronized or coordinated cardiac pacing based on each patient's clinical needs. This technology employs high-frequency pulses to transmit messages through the body's naturally conductive blood properties, resulting in efficient communication while consuming minimal battery power.

Unlike traditional pacemakers, which require cardiac leads, leadless pacemakers are directly implanted into the heart using minimally invasive procedures. This eliminates potential complications related to leads and infections and offers a shorter recovery period. The AVEIR DR leadless pacing system, significantly smaller than traditional pacemakers, consists of two devices: the previously approved AVEIR VR single-chamber pacemaker for the right ventricle and the newly approved AVEIR AR single-chamber pacemaker for the right atrium. These devices utilize Abbott's i2i technology to enable beat-to-beat communication between them.

Abbott's dual-chamber leadless pacemakers represent a significant advancement in medical technology, providing improved access to leadless pacing for millions of individuals in need. The smaller size and wireless communication capabilities of these pacemakers offer numerous benefits, revolutionizing care for patients with slow or abnormal heart rhythms.

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