Abbott's Groundbreaking Dual Chamber Leadless Pacemaker Granted FDA Approval

Thursday, July 06, 2023

Abbott, a leading medical technology company, has received FDA approval for its groundbreaking dual chamber leadless pacemaker. This innovative technology enables wireless communication and synchronization between two leadless pacemakers, making it the first of its kind in the world. Notably, these leadless pacemakers are smaller than a AAA battery.

Leadless pacemakers offer a minimally invasive option for treating various slow or abnormal heart rhythms, revolutionizing care for a larger population in the United States. Traditional pacemakers typically require pacing in two chambers of the heart—the right atrium and right ventricle. With the FDA's approval of Abbott's dual chamber leadless pacemaker, access to this advanced pacing technology is significantly expanded, benefiting millions of individuals.

The approval follows recent late-breaking clinical trial data demonstrating the safety and effectiveness of Abbott's AVEIR™ DR leadless pacemaker system in treating abnormal heart rhythms. By utilizing Abbott's proprietary i2i™ communication technology, the AVEIR DR devices achieve synchronized or coordinated cardiac pacing between the two leadless pacemakers based on the patient's clinical needs.

This communication occurs through high-frequency pulses transmitted via the body's naturally conductive characteristics, offering an efficient and low-power solution compared to other communication methods like inductive, radio frequency, or Bluetooth® used in traditional pacemakers or implantable medical devices.

Compared to traditional pacemakers, the AVEIR DR leadless pacemaker system is approximately one-tenth of the size. It comprises two devices—the previously approved AVEIR VR single chamber device for pacing the right ventricle and the newly approved AVEIR AR single chamber device for pacing the right atrium. The integration of Abbott's i2i technology addresses the engineering challenge of establishing beat-to-beat communication between the two leadless pacemakers.

Implanted through a minimally invasive procedure, leadless pacemakers eliminate the need for cardiac leads, reducing the risk of lead-related complications and infection. Furthermore, recovery periods following implantation are shorter and less restrictive. In clinical trials, the AVEIR DR leadless pacemaker system demonstrated an impressive implant success rate of 98.3% for physicians, with over 97% of patients achieving successful atrio-ventricular synchrony despite various underlying slow heart rhythms.

Each AVEIR pacemaker is smaller, slimmer, and shorter than a AAA battery, and it attaches to the heart's interior surface using a helix screw-in mechanism. This mechanism allows for potential device retrieval or replacement in the future based on evolving therapy needs. Additionally, the AVEIR DR system offers real-time pacing analysis, enabling physicians to assess proper device placement before implantation.

Abbott's dual chamber leadless pacemaker represents a significant advancement in cardiac care, providing a less invasive and highly effective option for treating slow or abnormal heart rhythms. With FDA approval secured, this pioneering technology has the potential to improve the quality of life for millions of individuals in the United States and beyond.



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