USA – As part of its AVEIR DR i2i pivotal clinical study, Abbott has announced the world’s first patient implants of a dual-chamber leadless pacemaker system.

Abbott’s investigational Aveir dual-chamber leadless pacemaker implant represents a technological milestone for leadless pacing technology.

The study is being co-chaired by Daniel J. Cantillon, M.D., clinical trial steering committee co-chair and Associate Section Head and Research Director of Cardiac Electrophysiology and Pacing, Cleveland Clinic. M.D., and Reinoud Knops, M.D., Ph.D., clinical trial steering committee co-chair and Department of Cardiology and Electrophysiology, Amsterdam University Medical Center, The Netherlands.

Leadless pacemakers, as opposed to traditional pacemakers, are implanted directly into the heart via a minimally invasive catheter-based procedure and do not require cardiac leads.

While leadless pacemakers regulate heart rate in the same way as traditional pacemakers, they have fewer lead-related complications and a shorter recovery period due to the minimally invasive implant procedure.

However, due to the difficulty of synchronizing two leadless pacemakers, leadless pacing options have historically been limited to single-chamber devices.

Abbott’s “i2i technology” was used to provide beat-by-beat communication between two leadless pacemakers, one in the right ventricle and one in the right atrium.

The first implant was carried out at Na Homolce Hospital in Prague, Czech Republic, under the supervision of site principal investigator Petr Neuzil, M.D., Ph.D., Head of the Department of Cardiology, and with the assistance of site co-investigator Vivek Y. Reddy, M.D.

The first-in-human implant of a dual-chamber leadless pacemaker is a major clinical milestone that will open up new possibilities for patients requiring pacing support.

Dr. Daniel J. Cantillon, Cardiologist, Cleveland Clinic.


Investing in leadless pacing technology

Abbott has made significant investments in leadless pacing technology, which has the potential to improve care for more patients suffering from abnormal heart rhythms.

The latest milestone for the Aveir DR leadless pacemaker comes on the heels of recent data showing that Abbott’s investigational single-chamber leadless pacemaker – Aveir VR – met the pivotal trial’s pre-specified primary endpoints.

Aveir DR has been designed to address a critical need for patients, as nearly 80% of people who receive a pacemaker require a dual-chamber option to pace both chambers on the right side of the heart.

Additionally, the Aveir DR system is intended to provide real-time mapping capability, allowing physicians to assess therapy delivery and reposition the device prior to implanting it during a patient’s procedure.

Medtronic’s Micra AV, on the other hand, is a single leadless pacemaker with several internal atrial sensing algorithms that detect cardiac movement.

The Micra AV can adjust ventricle pacing to sync with the atrium, allowing it to provide “AV synchronous” pacing therapy to patients with atrioventricular block.

Previously, people with AV block required a dual-chamber pacemaker, despite the fact that only one of the two leads in the system provided heart stimulation.

Abbott’s Aveir DR is also designed to be retrievable as therapy needs change. According to a news release, it can also provide real-time mapping for physicians to assess therapy delivery and reposition the device before implant during a patient’s procedure.

This technology is intended to synchronize the heart rate between chambers and enable true dual-chamber leadless pacing.

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