Abbott Receives CE Mark for AVEIR DR Leadless Pacemaker System

Abbott has received a CE Mark in Europe for the Aveir dual chamber (DR) leadless pacemaker system. Aveir is the world’s first dual-chamber leadless pacemaker that treats people with abnormal or slow heart rhythms.
 
Aveir DR is a breakthrough innovation that enables beat-to-beat, wireless communication between two leadless pacemakers and is designed to expand treatment options in Europe. The system received U.S. FDA approval in June 2023.
 
“Receiving CE Mark for Aveir DR is a historic moment in European cardiac care. This technology redefines how we approach the treatment of heart rhythm abnormalities,” Professor Reinoud Knops, M.D. PhD, from the department of cardiac electrophysiology at the Amsterdam University Medical Center told the press. “As the world’s first dual chamber leadless pacemaker, Aveir DR is a game changer, expanding our capacity to address complex heart conditions, and significantly reducing complication risk and enhance patient comfort.”
 
Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure and eliminate cardiac leads. Leadless pacemakers reduce exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implantation.
 
Aveir DR delivers dual-chamber therapy through two devices—one paces the right ventricle, and one paces the right atrium. Each device is roughly one-tenth the size of a traditional pacemaker and smaller than a AAA battery.
 
Aveir DR provides synchronized pacing between two leadless pacemakers on every heartbeat based on a person’s clinical needs.
 
Abbott uses proprietary i2i (implant-to-implant) communication technology. The i2i technology uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between the paired, co-implanted devices. Conductive communication uses far less battery current than traditional pacemakers. 
 
“Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization of two leadless pacemakers has been a significant challenge,” said Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer at Abbott’s cardiac rhythm management business. “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 showed that the system met three pre-specified primary endpoints for safety and efficacy.