US-based medical device company Abbott has received CE Mark approval for its AVEIR dual chamber (DR) leadless pacemaker system to treat people with abnormal or slow heart rhythms.
AVEIR DR is the world’s first dual-chamber leadless pacemaker to enable beat-to-beat, wireless communication between two leadless pacemakers.
It comes with a new approach to delivering dual-chamber therapy involving two unique devices, one pacing the right ventricle (AVEIR VR) and the other pacing the right atrium (AVEIR AR).
In the AVEIR DR i2i Global Clinical Investigation study, the leadless pacemaker system has met its three prespecified primary endpoints for safety and efficacy.
The study results showed a 98.3% system implant success rate and successful atrioventricular synchrony in more than 97% of people, despite different postures and gaits.
Abbott chief medical officer and cardiac rhythm management business medical affairs divisional vice president Leonard Ganz said: “Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization 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.”
According to the company, a traditional pacemaker is a small battery-powered device that is implanted underneath the skin in the chest through a surgical procedure.
It delivers electrical pulses to the heart through thin insulated wires, known as cardiac leads, and the treatment leaves a scar on the chest and the device bulge that is visible.
Unlike traditional pacemakers, a leadless pacemaker is implanted directly into the heart through a minimally invasive procedure, eliminating cardiac leads.
Leadless pacemakers result in reduced exposure to potential lead and infection-related complications and provide a shorter recovery period post-implantation that is less restrictive.
Abbott said that its AVEIR DR provides synchronised pacing between two leadless pacemakers on every heartbeat, building on its unique implant-to-implant (i2i) communication technology.
The i2i technology involves high-frequency pulses to relay messages through the naturally conductive characteristics of the body’s blood between the paired, co-implanted devices.
Amsterdam University Medical Center department of cardiac electrophysiology professor Reinoud Knops said: “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.
“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 risk3 and enhance patient comfort.”
