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  • Abbott Receives FDA Approval for World's First Dual Chamber Leadless Pacemaker

    • Abbott’s breakthrough technology enables the world's first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery
    • Leadless pacemakers provide a new minimally invasive option that will revolutionize care for more people in the U.S. who need pacing to treat a variety of slow or abnormal heart rhythms
    • Approval comes on the heels of recent late-breaking clinical trial data showing that the AVEIR™ DR leadless pacemaker system is safe and effective at treating abnormal heart rhythms

    ABBOTT PARK, Ill., July 5, 2023 — Abbott today 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.[i]

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