Abbott Receives CE Mark for Aveir DR Dual-Chamber Leadless Pacemaker System

June 17, 2024—Abbott announced it received European CE Mark approval for the Aveir DR dual-chamber leadless pacemaker system for treating patients with abnormal or slow heart rhythms. The Aveir DR device enables beat-to-beat, wireless communication between two leadless pacemakers.

The company announced FDA approval of the Aveir DR leadless pacemaker system in the United States in July 2023.

According to Abbott, the Aveir DR leadless pacemaker system delivers dual-chamber therapy with two devices: one that paces the right ventricle (Aveir VR) and one that paces the right atrium (Aveir AR). Each device is approximately one-tenth the size of a traditional pacemaker and smaller than a AAA battery.

“Receiving CE Mark for Aveir DR is a historic moment in European cardiac care,” commented Professor Reinoud Knops, MD, in Abbott’s press release. “This technology redefines how we approach the treatment of heart rhythm abnormalities.”

Prof. Knops, with the Department of Cardiac Electrophysiology at Amsterdam University Medical Center in the Netherlands continued, “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 enhancing patient comfort.”

In the press release, the company stated that Abbott’s i2i implant-to-implant communication technology allows the Aveir DR to provide synchronized pacing between two leadless pacemakers on every heartbeat based on a patient’s clinical needs. The i2i technology uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between the paired, coimplanted devices.

Abbott noted that the AVEIR DR i2i global clinical investigation study showed that Aveir DR met its three prespecified primary endpoints for safety and efficacy. Results through 3 months postimplant showed a 98.3% system implant success rate and > 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally despite different postures and gaits, reported the company.