Abbott made a significant announcement today regarding the approval of the AVEIR™ dual chamber

Abbott made a significant announcement today regarding the approval of the AVEIR™ dual chamber (DR) leadless pacemaker system by the U.S. Food and Drug Administration (FDA). This groundbreaking pacing system is the world’s first of its kind and is designed to treat individuals with abnormal or slow heart rhythms. The approval marks a major milestone as it expands access to leadless pacing for millions of people across the United States, considering that over 80% of individuals in need of a pacemaker require pacing in both the right atrium and right ventricle of the heart.

Dr. Vivek Y. Reddy, the director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System, expressed his enthusiasm, stating, “Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual chamber leadless pacing to that list of achievements. In delivering a true dual chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and providing additional options to improve our ability to treat people with slow or abnormal heart rhythms.”

Abbott’s AVEIR DR devices utilize their proprietary i2i™ communication technology to provide synchronized or coordinated cardiac pacing between the two leadless pacemakers, based on the individual’s clinical needs. The i2i technology utilizes high-frequency pulses to transmit messages through the body’s naturally conductive blood, allowing each implant to communicate beat-to-beat with its paired, co-implanted device. This conductive communication is crucial as it consumes far less battery current compared to other alternatives like inductive, radio frequency, or Bluetooth® communication used in traditional pacemakers or implantable medical devices.

The AVEIR DR leadless pacing system is approximately one-tenth the size of a traditional pacemaker and comprises two devices: the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the newly-approved AVEIR AR single chamber device, which paces the right atrium. The AVEIR DR system incorporates Abbott’s innovative i2i technology, which overcomes a significant engineering challenge by enabling beat-to-beat communication between the two leadless pacemakers.

Unlike traditional pacemakers, which require invasive procedures and the use of cardiac leads, leadless devices like AVEIR are directly implanted into the heart through minimally invasive procedures. This eliminates the need for leads and reduces potential complications related to leads and infections. Additionally, leadless pacemakers offer a shorter and less restrictive recovery period after implantation.

The FDA approval of the AVEIR DR dual chamber leadless pacemaker system follows recent late-breaking clinical data published in The New England Journal of Medicine. The study demonstrated that the AVEIR DR system met its three primary endpoints for safety and efficacy. Three months post-implantation, the study reported a 98.3% implant success rate for physicians and over 97% of individuals achieved successful atrio-ventricular synchrony, ensuring normal functioning of the upper and lower chambers despite different types of underlying slow heart rhythms.

Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, commented, “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. 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.”

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