Abbott receives approval for AVEIR DR, world’s first dual chamber leadless pacemaker system

June 10, 2024- The Abbott AVEIR™ dual chamber (DR) leadless pacemaker system is the world’s first dual chamber leadless pacemaker that treats people with abnormal or slow heart rhythms. Approximately 49 million people are living with cardiovascular disease in the European Union, and it is estimated that 14.4 million people 65 and older will have atrial fibrillation by 2060, according to Abbott. AVEIR DR is a breakthrough innovation that enables the world’s first beat-to-beat, wireless communication between two leadless pacemakers, designed to address the needs of people living with abnormal heart rhythms and expand treatment options.

The AVEIR DR i2i Global Clinical Investigation study showed that AVEIR DR met its three prespecified primary endpoints for safety and efficacy. Results through three-months post-implant showed a 98.3% system implant success rate and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally, despite different postures and gaits.

The AVEIR DR leadless pacemaker system received U.S. FDA approval in June 2023.

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Abbott Press Release

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