Abbott has completed the first-in-human leadless left bundle branch area pacing (LBBAP) procedure using its investigational AVEIR Conduction System Pacing (CSP) leadless pacemaker system.
This breakthrough marks the first use of a leadless pacemaker in the left bundle branch area, a crucial part of the heart’s electrical conduction system.
The procedure offers a new treatment option for people with slow heart rhythms, mimicking the heart’s natural beat.
Abbott said the procedures were part of the Leadless CSP feasibility study, assessing the acute safety and performance of the investigational AVEIR CSP leadless pacemaker system.
Performed in the fall of 2024, the procedures were led by Petr Neužil, head of cardiology at Na Homolce Hospital in Prague, and Vivek Y. Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital, New York. Both are principal investigators of the study.
Abbott cardiac rhythm management business senior vice president Randel Woodgrift said: “Bringing our proven leadless pacemaker technology to the left bundle branch area has great potential to be another transformative moment in cardiac care.
“By continuously innovating our approach to pacing, Abbott is revolutionising care for millions of people living with slow or irregular heart rhythms.”
According to Abbott, CSP is an evolving technique where a traditional pacemaker wire is implanted deep into the wall between the heart’s left and right chambers.
This method activates the left bundle branch area, enabling physiological pacing that mimics the heart’s natural electrical current.
The integration of CSP procedures with leadless pacemaker technology offers benefits over traditional pacemakers, the American health technology firm said.
Leadless systems eliminate the need for cardiac leads and a pulse generator under the skin, reducing the long-term risks of lead- and pocket-related complications.
The US Food and Drug Administration (FDA) had granted breakthrough device designation to Abbott’s AVEIR CSP leadless pacemaker system for LBBAP.
Abbott’s AVEIR dual chamber (DR) leadless pacemaker system received FDA approval in June 2023. Almost an year later, the DR leadless pacemaker secured CE Mark approval.
Featuring novel i2i (implant-to-implant) technology, the AVEIR DR system provides synchronised pacing by using high-frequency electrical impulses to transmit messages between co-implanted leadless pacemakers.
The AVEIR CSP leadless pacemaker system is still in development and is not yet commercially available.
