Abbott announces first-in-world leadless pacing procedures in the left bundle branch area of the heart

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Abbott announced successful completion of the world's first in-human leadless left bundle branch area pacing (LBBAP) procedures using the company's investigational AVEIR™ Conduction System Pacing (CSP) leadless pacemaker system, as part of a feasibility study. These procedures mark the first time a leadless pacemaker has been implanted into the left bundle branch area, a key part of the heart's electrical conduction system, designed to mimic the heart's natural beat, offering people with slower-than-normal heart rhythms a new potential treatment option.

The landmark procedures were part of the prospective Leadless CSP feasibility study, which evaluates the acute safety and performance of the investigational AVEIR CSP leadless pacemaker system. CSP is an evolving technique in which a traditional pacemaker wire is implanted deep into the wall separating the left and right chambers of the heart. This approach 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 improve the physiological response from the heart compared with other pacing options. The seamless integration of CSP procedures with leadless pacemaker technology has the potential to deliver unique benefits over traditional pacemakers.

Abbott's AVEIR dual chamber (DR) leadless pacemaker system received FDA approval in June of 2023. Through its novel i2i™ (implant-to-implant) technology, the AVEIR DR leadless pacemaker system provides synchronized pacing by utilizing high-frequency electrical impulses to relay messages between co-implanted leadless pacemakers via the naturally conductive characteristics of the body's blood and tissue. The AVEIR CSP leadless pacemaker system is in development and not commercially available. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of Abbott's AVEIR CSP leadless pacemaker system for LBBAP. Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.