Abbott Park- June 2024- Abbott announced it has received CE Mark in Europe for the AVEIR™ dual chamber (DR) leadless pacemaker system, 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. It is estimated that 14.4 million people 65 and older will have atrial fibrillation by 2060. 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 in Europe.

The AVEIR DR leadless pacemaker system utilizes a new method of delivering dual-chamber therapy as it is comprised of two unique devices – one that paces the right ventricle (AVEIR VR) and one that paces the right atrium (AVEIR AR). Each device is roughly one-tenth the size of a traditional pacemaker and smaller than a AAA battery.

Surgeons implant a traditional pacemaker, a small battery-powered device, underneath the skin in the chest through a surgical procedure. The device delivers electrical therapy to the heart via thin insulated wires better known as cardiac leads, and often leaves a chest scar and device bulge that is visible. Leadless devices, unlike traditional pacemakers, are implanted directly into the heart through a minimally invasive procedure, eliminating cardiac leads. As a result, leadless pacemakers reduce people’s exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implantation.

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“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,” said Professor Reinoud Knops, M.D. PhD, from the department of cardiac electrophysiology at the Amsterdam University Medical Center. “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.”

“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.”