USA — Abbott, a renowned leader in medical technology, has recently announced a groundbreaking advancement in cardiac care.

The U.S. Food and Drug Administration (FDA) has granted approval to Abbott’s AVEIR dual-chamber (DR) leadless pacemaker system, marking a remarkable milestone in the field.

This revolutionary system is the world’s first of its kind, specifically designed to treat patients with abnormal or slow heart rhythms.

Unlike traditional pacemakers, the AVEIR dual-chamber leadless pacemaker is implanted directly into the heart using a minimally invasive procedure, eliminating the need for cardiac leads.

This innovative approach brings about several significant advantages, including a reduced risk of complications related to leads and infections, as well as a quicker and less restrictive recovery period after implantation.

The approval of the AVEIR dual-chamber leadless pacing system represents a major breakthrough in treating abnormal or slow heart rhythms.

Previously, leadless pacemakers were limited to single-chamber devices due to the complex engineering challenge of achieving wireless synchronization between two pacemakers. However, Abbott’s team of experts has successfully overcome this obstacle.

Randel Woodgrift, head of Abbott’s cardiac rhythm management business, expressed their accomplishment, stating, “Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge – until now.”

Woodgrift further added, “Our team… solved one of medtech’s complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology.”

Abbott emphasizes that this approval will significantly expand access to advanced pacing technology for millions of individuals in the United States.

Prior to this breakthrough, the majority of people requiring a pacemaker, approximately 80%, needed pacing in two chambers of the heart — the right atrium and right ventricle.

The AVEIR DR system features cutting-edge i2i communication technology, which utilizes high-frequency pulses to transmit messages through the naturally conductive characteristics of the body’s blood between each leadless pacemaker.

Abbott highlights that each implant communicates “beat-to-beat” with its paired, co-implanted device, using “far less battery current” compared to other alternatives like inductive, radio frequency, or Bluetooth communication, commonly used in implantable medical devices or traditional pacemakers.

Remarkably, the AVEIR DR is approximately one-tenth the size of a traditional pacemaker. It comprises the previously-approved AVEIR VR single-chamber device, responsible for pacing the right ventricle, and the newly-approved AVEIR AR single-chamber device, which paces the right atrium.

Furthermore, the AVEIR DR system is designed to provide real-time pacing analysis. This feature enables physicians to assess the accurate placement of the device during the procedure and before implanting it inside the heart chamber, ensuring optimal performance.

The NEJM (New England Journal of Medicine) published clinical data demonstrating that the AVEIR DR system successfully achieved its primary safety and efficacy endpoints.

Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study revealed an impressive 98.3% implant success rate within three months post-procedure.

Additionally, more than 97% of patients achieved successful atrioventricular synchrony, even with various underlying slow heart rhythms.

In contrast to Abbott’s AVEIR dual-chamber leadless pacemaker, Medtronic’s Micra AV is a single leadless pacemaker equipped with several internal atrial sensing algorithms.

These algorithms detect cardiac movement, allowing the Micra AV to adjust pacing in the ventricle to synchronize with the atrium. Consequently, it offers “AV synchronous” pacing therapy for individuals with atrioventricular block.

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