World's First Dual-Chamber Leadless Pacemaker to Revolutionize Treatment of Abnormal Heart Rhythms

By HospiMedica International staff writers
Posted on 06 Jul 2023

Image: The AVEIR dual chamber leadless pacemaker system has received FDA approval (Photo courtesy of Abbott)

In comparison to traditional pacemakers, leadless devices are directly implanted into the heart through a minimally invasive procedure, thereby eliminating the requirement for cardiac leads. This results in a reduced risk of lead and infection-related complications and provides a less restrictive and quicker post-implantation recovery period. More than 80% of pacemaker patients require pacing in two heart chambers (both the right atrium and right ventricle). However, until now, leadless pacemakers have been limited to a single chamber device due to the engineering challenge of achieving wireless synchronization between two pacemakers. Now, a breakthrough technology enables the world's first beat-to-beat, wireless communication, and synchronization between two leadless pacemakers, which are smaller than an AAA battery.

Abbott’s (Lake Forest, IL, USA) AVEIR DR is the world's first dual chamber leadless pacing system designed for treating individuals with abnormal or slow heart rhythms. Approximately one-tenth the size of a standard pacemaker, the AVEIR DR leadless pacing system consists of two devices – the AVEIR VR single chamber device that paces the right ventricle, and the AVEIR AR single chamber device that paces the right atrium. Abbott's proprietary i2i communication technology allows for synchronized or coordinated cardiac pacing between the two leadless pacemakers based on the individual's clinical needs. This technology uses high-frequency pulses to transmit messages through the body's naturally conductive blood characteristics between each leadless pacemaker.

Each implant supports dual chamber therapy by communicating beat-to-beat with a paired, co-implanted device. This conductive communication is vital as it consumes less battery power than inductive, radio frequency, or Bluetooth communication used in other implantable medical devices or conventional pacemakers. Each AVEIR pacemaker, shorter, smaller and slimmer than an AAA battery, is implanted via a minimally invasive procedure. The device connects to the inner heart surface with a screw-in mechanism, known as a helix, allowing for future device retrieval if therapy needs change or device replacement becomes necessary. The AVEIR DR system also provides real-time pacing analysis, enabling physicians to confirm proper device placement during the procedure before implanting it into the heart chamber.

Following recent late-breaking clinical data demonstrating the AVEIR DR system's safety and efficacy, the U.S. Food and Drug Administration (FDA) has granted its approval for the device. Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study, spanning three months post-implantation, displayed a 98.3% implant success rate for physicians. Additionally, over 97% of patients achieved successful atrio-ventricular synchrony, indicating normal beating of the upper and lower chamber, despite various types of underlying slow heart rhythms.

"Our team of dedicated scientists and engineers solved one of medtech's complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business.

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