Abbott gets US FDA approval for AVEIR dual chamber leadless pacemaker system
Abbott announced that the US 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 US.
“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.”