Abbott secures European approval for dual-chamber Aveir leadless pacemaker system

Nearly a year after garnering an FDA nod, Abbott’s wireless, dual-chamber pacemaker system is crossing the pond with a CE Mark approval in Europe.

The Aveir DR includes a pair of separate devices, with one placed within the wall of the right ventricle and one above in the right atrium: the Aveir VR and AR, respectively. Each implant is smaller than a AAA battery, or about a tenth the size of a traditional pacemaker, and communicates with the other to help synchronize a patient’s heartbeats.

Abbott estimates that 49 million people in the European Union are living with cardiovascular disease today and that about 14.4 million people ages 65 and older will develop atrial fibrillation by the year 2060.

Conventional pacemakers include a separate generator that is wired into the heart with thin electrical leads. The more contained design of leadless pacemakers, implanted through a minimally invasive procedure, aims to avoid the complications that may come if the leads are displaced or develop an infection.

The Aveir DR’s two implants send signals through high-frequency pulses conducted across the blood itself, instead of using radio or Bluetooth wireless communication. A single-chamber Aveir previously received a CE Mark in July 2023.

A clinical trial showed that both pieces of the Aveir DR system were successfully implanted 98% of the time while 97% of patients displayed synchronization between the upper and lower chambers of the heart, regardless of the person’s posture or movement.

Earlier this year, Medtronic received European approvals for the latest versions of its Micra leadless pacemakers, the AV2 and VR2. The AV2 is capable of delivering atrioventricular synchrony as a solo device, by sensing the movement of the heart muscle, while the VR2 is cleared for single-chamber ventricular pacing.

Meanwhile, late last month Boston Scientific reported that its modular cardiac implant system—linking its investigational Empower leadless pacemaker with its Emblem subcutaneous implanted defibrillator—cleared a clinical study, showing the pair could help manage heart rhythms and step in to correct dangerous ones.