Saturday, June 15, 2024

Abbott’s AVEIR DR Pacemakers System Achieves CE Mark, Revolutionizing Cardiac Rhythm Management

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Pacemakers technology reaches a significant milestone in cardiac rhythm management with Abbott’s attainment of a CE Mark in Europe for its AVEIR DR leadless pacemaker system. Representing the world’s first dual-chamber leadless pacemaker, the AVEIR DR system offers a pioneering solution for individuals experiencing abnormal or slow heart rhythms.

This innovative system enables seamless communication between two leadless pacemakers, the AVEIR VR for the right ventricle and the AVEIR AR for the right atrium. Through Abbott’s implant-to-implant (i2i) communication technology, the AVEIR DR system facilitates synchronized pacing between the paired devices, ensuring optimal clinical adjustments on a beat-to-beat basis. Leveraging high-frequency pulses, the i2i technology utilizes the body’s blood as a natural conductor to efficiently relay messages between the co-implanted devices, resulting in optimized battery usage.

Abbott’s Pacemakers System Introduces Advanced, Discreet Solution for Abnormal Heart Rhythms

Engineered to cater to the needs of patients with abnormal heart rhythms, the AVEIR DR system offers a less invasive and more discreet pacing option compared to traditional pacemakers. Each device, approximately one-tenth the size of conventional pacemakers, represents a significant advancement in pacemaker design and functionality.

Leonard Ganz, Divisional Vice President of Medical Affairs and Chief Medical Officer of Abbott’s cardiac rhythm management business, highlighted the revolutionary impact of the AVEIR DR system on patient care. He emphasized the system’s ability to address a critical need for individuals living with slow heart rhythms while enhancing their quality of life through its innovative leadless design.


Pacemakers System Proven Safe and Effective, Gains FDA Approval for Cardiac Rhythm Management

Clinical investigations, including the AVEIR DR i2i Global Clinical Investigation study, have demonstrated the safety and efficacy of the system. With a 98.3% success rate in system implantation and over 97% of patients achieving successful atrioventricular synchrony, the results underscore the reliability of the AVEIR DR system in maintaining normal heart rhythms across various postures and activities.

The approval of the AVEIR DR leadless pacemaker system by the US Food and Drug Administration in July 2023 further solidifies its position as a groundbreaking advancement in cardiac rhythm management technology, promising improved patient outcomes and enhanced therapeutic options for individuals with abnormal heart rhythms.


Resource: Abbott, June 06, 2024

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