Abbott has completed the first-in-human procedures for leadless left bundle branch area pacing (LBBAP) using its AVEIR conduction system pacing (CSP) leadless pacemaker system.
The investigational system aims to provide a new potential treatment option for individuals with slower-than-normal heart rhythms.
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The procedures were part of the Leadless CSP feasibility study, which assesses the performance and safety of the AVEIR CSP system.
They were conducted by Na Homolce Hospital’s cardiology department head Petr Neužil and Mount Sinai Hospital’s cardiac arrhythmia services director Vivek Reddy this year.
As part of the CSP technique, a pacemaker wire is implanted deep into the heart wall, activating the left bundle branch area for physiological pacing. This method is believed to improve the heart’s response compared to other pacing options.
The AVEIR CSP system leverages leadless pacing technology, which does not require a pulse generator and cardiac leads under the skin, potentially reducing long-term risks associated with traditional pacemakers.
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By GlobalDataAbbott 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.”
The US Food and Drug Administration (FDA) has awarded the system a breakthrough device designation for LBBAP. AVEIR dual chamber (DR) leadless pacemaker system employs i2i technology for synchronised pacing.
The AVEIR CSP leadless pacemaker system is currently being developed and is unavailable commercially.
In April 2022, the US regulator approved the AVEIR single-chamber leadless pacemaker for treating individuals in the US with slow heart rhythms.
