Abbott has obtained a CE Mark in Europe for its AVEIR dual chamber (DR) leadless pacemaker system, marking a significant advancement in cardiac rhythm management technology.
Claimed to be the world's first dual-chamber leadless pacemaker, the AVEIR DR system is designed to treat individuals with abnormal or slow heart rhythms.
It is equipped to allow beat-to-beat, wireless communication between two leadless pacemakers.
Abbott's implant-to-implant (i2i) communication technology enables the AVEIR DR system to deliver synchronised pacing between the paired devices, adjusting to a patient's clinical requirements on a beat-to-beat basis.
The i2i technology employs high-frequency pulses that leverage the body's blood as a natural conductor to relay messages between the co-implanted devices, resulting in efficient battery usage.
AVEIR DR is engineered to meet the needs of patients with abnormal heart rhythms by offering a less invasive and more discreet pacing option compared to traditional pacemakers.
The system includes two devices, the AVEIR VR for the right ventricle and the AVEIR AR for the right atrium, each approximately one-tenth the size of conventional pacemakers.
Abbott cardiac rhythm management business divisional vice-president of medical affairs and chief medical officer Leonard Ganz said: “Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronisation of two leadless pacemakers has been a significant challenge.
“AVEIR DR addresses a critical need for people living with slow heart rhythms and enhances people's quality of life with its revolutionary leadless design.”
The AVEIR DR i2i Global Clinical Investigation study demonstrated the system's safety and efficacy, with a 98.3% success rate in system implantation and more than 97% of patients achieving successful atrioventricular synchrony.
These results were consistent across various postures and activities, confirming the system's reliability in maintaining normal heart rhythms.
In July 2023, the US Food and Drug Administration approved the AVEIR DR leadless pacemaker system.
