Abbott Finishes First-in-Human Leadless Left Bundle Branch Area Pacing Procedures

Abbott announced successful completion of the world’s first world’s first in-human leadless left bundle branch area pacing (LBBAP) procedures using its investigational Aveir Conduction System Pacing (CSP) leadless pacemaker system, as part of a feasibility study.

According to Abbott, these procedures are the first time a leadless pacemaker has been implanted into the left bundle branch area, a crucial part of the heart’s electrical conduction system. The pacemaker was designed to mimic the heart’s natural beat so people with slower-than-normal heart rhythms have a new possible treatment option.

These procedures were part of the company’s prospective Leadless CSP feasibility study. The procedures were completed in the fall of 2024 by Professor Petr Neužil, M.D., Ph.D., head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic, and the site’s principal investigator, and Vivek Y. Reddy, M.D., director of cardiac arrhythmia services at Mount Sinai Hospital, New York, and the study’s principal investigator.

CSP is an evolving technique where a traditional pacemaker wire is implanted deep into the wall separating the heart’s left and right chambers. This activates the left bundle branch area enabling physiological pacing which mimics the heart’s natural electrical current. As a result, physicians believe this pacing approach could boost the physiological response from the heart compared to other pacing options.

Leadless pacing systems also remove the need for cardiac leads and a pulse generator under the skin and avoid long-term risks of lead- and pocket-related complications.

The U.S. Food and Drug Administration (FDA) awarded breakthrough status to explore Aveir CSP’s use as a leadless pacemaker for LBBAP. Abbott’s Aveir dual chamber (DR) leadless pacemaker system received FDA approval in June 2023. The device earned CE mark clearance this past June.

“Bringing our proven leadless pacemaker technology to the left bundle branch area has great potential to be another transformative moment in cardiac care,” said Randel Woodgrift, senior VP of Abbott’s cardiac rhythm management business. “By continuously innovating our approach to pacing, Abbott is revolutionizing care for millions of people living with slow or irregular heart rhythms.”