Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the AVEIR dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms. With more than 80% of people who need a pacemaker requiring pacing in two chambers of the heart (both the right atrium and right ventricle), the approval significantly increases access to leadless pacing for millions of people across the U.S.
“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,” said Vivek Y. Reddy, M.D., director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System. “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 provided additional options to improve our ability to treat people with slow or abnormal heart rhythms.”
Through Abbott’s proprietary i2i communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person’s clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker. To support dual chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication is critical, because it uses far less battery current than inductive, radio frequency or Bluetooth communication which are other alternatives used in implantable medical devices or traditional pacemakers.
Roughly one-tenth the size of a traditional pacemaker, the AVEIR DR leadless pacing system is made up of two devices – the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. The AVEIR DR system incorporates Abbott‘s novel i2i technology, which solves a significant engineering challenge by offering beat-to-beat communication between the two leadless pacemakers.
SOURCE: PRNewswire