17, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the 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.

172024/PRNewswire/--雅培（纽约证券交易所：ABT）今天宣布，作为可行性研究的一部分，使用该公司的研究性AVEIR™传导系统起搏（CSP）无铅起搏器系统，成功完成了世界上第一个人体无铅左束支区起搏（LBBAP）程序。

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..

这些程序标志着第一次将无铅起搏器植入左束支区域，左束支区域是心脏传导系统的关键部分，旨在模拟心脏的自然搏动，为心律低于正常的人提供了一种新的潜在治疗选择。。

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. 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.

具有里程碑意义的程序是前瞻性无铅CSP可行性研究的一部分，该研究评估了AVEIR CSP无铅起搏器系统的急性安全性和性能。该程序于2024年秋季由捷克共和国布拉格Na Homolce医院心脏病学系主任Petr Neužil教授和Vivek Y完成。

Reddy, M.D., director of cardiac arrhythmia services at Mount Sinai Hospital, New York, and the study's principal investigator..

医学博士Reddy是纽约西奈山医院心律失常服务主任，也是该研究的首席研究员。。

'While both conduction system pacing and leadless pacing provide distinct benefits to many patients, they have been separate options – until now,' said Devi Nair, M.D., director of cardiac electrophysiology at St. Bernards Medical Center, Jonesboro, Arkansas, and a key contributor to the study. 'For the first time, the study of the AVEIR CSP leadless pacemaker system evaluates a pioneering approach that directly targets the left bundle branch area, combining the advantages of conduction system and leadless pacing technologies.'.

阿肯色州琼斯伯罗圣伯纳德医学中心心脏电生理学主任、该研究的关键贡献者德维·奈尔（Devi Nair）医学博士说：“虽然传导系统起搏和无铅起搏对许多患者都有明显的益处，但到目前为止，它们一直是单独的选择。”AVEIR CSP无铅起搏器系统的研究首次评估了一种开创性的方法，该方法直接针对左束支区域，结合了传导系统和无铅起搏技术的优势。”。

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..

CSP是一种不断发展的技术，在这种技术中，传统的起搏器导线被深深植入分隔左心室和右心室的壁中。这种方法激活左束支区域，使生理起搏能够模拟心脏的自然电流。因此，医生认为，与其他起搏选择相比，这种起搏方法可以改善心脏的生理反应。。

The seamless integration of CSP procedures with leadless pacemaker technology has the potential to deliver unique benefits over traditional pacemakers. Leadless pacing systems eliminate the need for cardiac leads and a pulse generator under the skin and avoid long-term risks of lead- and pocket-related complications.

CSP程序与无铅起搏器技术的无缝集成有可能提供优于传统起搏器的独特优势。无铅起搏系统消除了对心脏导线和皮肤下脉冲发生器的需求，避免了与导线和口袋相关的并发症的长期风险。

As a result, leadless pacemakers like the AVEIR family of products are a potential solution for some of the complications often associated with traditional pacemakers..

因此，像AVEIR系列产品这样的无铅起搏器是解决传统起搏器常见并发症的潜在方法。。

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..

美国食品和药物管理局（FDA）已授予突破性的设备名称，以探索将雅培的AVEIR CSP无铅起搏器系统用于LBBAP。突破性的设备设计加速了对创新技术的审查，这些技术可以改善患有威胁生命或不可逆转的衰弱疾病或病症的人的生活。。

'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 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.'.

雅培心律管理业务高级副总裁兰德尔·伍德格里夫特（RandelWoodgrift）说，将我们经过验证的无铅起搏器技术引入左束支区域，有很大潜力成为心脏护理领域的另一个变革时刻通过不断创新我们的起搏方法，雅培正在彻底改变对数百万心律缓慢或不规则患者的护理。”。

Completing the research team were Rahul Doshi, M.D., chief cardiac arrhythmia group at HonorHealth, Scottsdale, Arizona; and Shephal Doshi, M.D., executive director at Heart and Vascular Institute, Providence Saint John's Health Center, Santa Monica, California -- key contributors in the feasibility study and completion of the procedures..

完成研究团队的是亚利桑那州斯科茨代尔HonorHealth的首席心律失常小组医学博士RahulDoshi；加利福尼亚州圣莫尼卡市普罗维登斯圣约翰健康中心心脏与血管研究所执行主任Shephal Doshi医学博士是可行性研究和程序完成的关键贡献者。。

About the AVEIR Leadless Pacemaker SystemAbbott'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.

关于AVEIR无铅起搏器系统Abbott的AVEIR双腔（DR）无铅起搏器系统于2023年6月获得FDA批准。AVEIR DR无铅起搏器系统通过其新颖的i2i™（植入物到植入物）技术，利用高频电脉冲，通过人体血液和组织的自然导电特性，在共同植入的无铅起搏器之间传递信息，从而提供同步起搏。

The AVEIR CSP leadless pacemaker system is in development and not commercially available. .

AVEIR CSP无铅起搏器系统正在开发中，尚未上市。。

About Abbott:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

关于雅培：雅培是一家全球医疗保健领导者，帮助人们在生命的各个阶段都过得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，在诊断、医疗器械、营养品和品牌仿制药领域拥有领先的业务和产品。我们的114000名同事为160多个国家的人民服务。。