Abbott Completes First-in-Human Leadless Left Bundle Branch Area Pacing Procedures
核心洞察
Abbott has successfully completed first-in-human procedures using its AVEIR CSP (搜索) leadless pacemaker system for left bundle branch area (搜索) pacing (LBBAP).
The AVEIR CSP (搜索) system aims to provide a new treatment option for individuals with slower-than-normal heart rhythms by pacing the left bundle branch area (搜索).
The FDA has granted Breakthrough Device Designation to Abbott's AVEIR CSP (搜索) leadless pacemaker system, expediting its review process.
Abbott has announced the successful completion of the world's first in-human leadless left bundle branch area (搜索) pacing (LBBAP) procedures using its investigational AVEIR (搜索)™ Conduction System Pacing (CSP) leadless pacemaker system. These procedures, conducted as part of a feasibility study, mark a significant advancement in cardiac pacing technology, offering a potential new treatment option for individuals with slower-than-normal heart rhythms.
The procedures were performed in the fall of 2024 by Professor Petr Neužil, M.D., Ph.D., at Na Homolce Hospital in Prague, Czech Republic, and Vivek Y. Reddy, M.D., at Mount Sinai Hospital in New York, both serving as principal investigators for the Leadless CSP feasibility study. This prospective study is designed to evaluate the acute safety and performance of the AVEIR CSP (搜索) leadless pacemaker system.
Targeting the Left Bundle Branch Area
Conduction system pacing (CSP) is an evolving technique that involves implanting a pacemaker wire deep into the heart wall, specifically targeting the left bundle branch area (搜索). This approach aims to activate the heart's natural electrical conduction system, mimicking its physiological function. Physicians believe that LBBAP could improve the heart's response compared to traditional pacing methods.
"For the first time, the study of the AVEIR CSP (搜索) leadless pacemaker system evaluates a pioneering approach that directly targets the left bundle branch area (搜索), combining the advantages of conduction system and leadless pacing technologies," said Devi Nair, M.D., director of cardiac electrophysiology at St. Bernards Medical Center, Jonesboro, Arkansas, and a key contributor to the study.
Advantages of Leadless Pacing
The AVEIR CSP (搜索) system integrates the benefits of CSP with leadless pacemaker technology. Leadless pacing systems eliminate the need for cardiac leads and a pulse generator under the skin, potentially reducing long-term risks associated with lead- and pocket-related complications. This offers a significant advantage over traditional pacemakers, which can be prone to such issues.
FDA Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott's AVEIR CSP (搜索) leadless pacemaker system for LBBAP. This designation expedites the review process for innovative technologies that have the potential to improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
Abbott's Commitment to Innovation
"Bringing our proven leadless pacemaker technology to the left bundle branch area (搜索) has great potential to be another transformative moment in cardiac care," said Randel Woodgrift, senior vice president 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 (搜索)."
About the AVEIR Leadless Pacemaker System
Abbott's AVEIR (搜索) dual chamber (DR) leadless pacemaker system received FDA approval in June 2023. The AVEIR DR system utilizes i2i™ (implant-to-implant) technology to provide synchronized pacing through high-frequency electrical impulses transmitted between co-implanted leadless pacemakers, leveraging the body's natural conductive properties. The AVEIR CSP (搜索) leadless pacemaker system is currently under development and is not yet commercially available.