Aveir DR: Abbott gets CE mark for Dual chamber leadless pacemaker system

"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."

Through Abbott's proprietary i2i (implant-to-implant) communication technology, AVEIR DR provides synchronized pacing between two leadless pacemakers on every heartbeat based on a person's clinical needs. The i2i technology utilizes 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 inductive, radio-frequency, or Bluetooth communication, which are alternatives often used in implantable medical devices or 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 AVEIR DR met its three prespecified primary endpoints for safety and efficacy. Results through three-months post-implant showed a 98.3% system implant success rate and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally, despite different postures and gaits.

The AVEIR DR leadless pacemaker system received U.S. FDA approval in June 2023.

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