ABBOTT PARK, Ill., June 6, 2024 — Abbott today announced it has received CE Mark in Europe for the AVEIR™ dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacemaker that treats people with abnormal or slow heart rhythms. Approximately 49 million people are living with cardiovascular disease in the European Union, and it is estimated that 14.4 million people 65 and older will have atrial fibrillation by 2060.1 2  AVEIR DR is a breakthrough innovation that enables the world's first beat-to-beat, wireless communication between two leadless pacemakers, designed to address the needs of people living with abnormal heart rhythms and expand treatment options in Europe..

伊利诺伊州雅培公园，2024年6月6日讯-雅培今天宣布，其AVEIR™双腔（DR）无铅起搏器系统在欧洲获得CE标志，该系统是世界上第一款治疗心律异常或缓慢患者的双腔无铅起搏器。在欧盟，大约有4900万人患有心血管疾病，据估计，到2060年，将有1440万65岁及以上的人患有心房颤动。2 AVEIR DR是一项突破性创新，它实现了世界上第一个两个无铅起搏器之间的逐搏无线通信，旨在满足心律异常患者的需求，并扩大欧洲的治疗选择。。

The AVEIR DR leadless pacemaker system utilizes a new method of delivering dual chamber therapy as it is comprised of two unique devices – one that paces the right ventricle (AVEIR VR) and one that paces the right atrium (AVEIR AR). Each device is roughly one-tenth the size of a traditional pacemaker and smaller than a AAA battery..

AVEIR DR无铅起搏器系统采用了一种提供双腔治疗的新方法，因为它由两个独特的设备组成-一个用于右心室起搏（AVEIR VR），另一个用于右心房起搏（AVEIR AR）。每个设备大约是传统起搏器的十分之一大小，比AAA电池小。。

A traditional pacemaker is a small battery-powered device implanted underneath the skin in the chest through a surgical procedure. The device delivers electrical therapy to the heart via thin insulated wires better known as cardiac leads, and often leaves a chest scar and device bulge that is visible.

传统的起搏器是一种小型电池供电装置，通过外科手术植入胸部皮肤下方。该设备通过细绝缘线（通常称为心脏导线）向心脏提供电疗，并且通常会留下胸部疤痕和可见的设备凸起。

Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure, eliminating cardiac leads. As a result, leadless pacemakers reduce people's exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implantation..

与传统的起搏器不同，无铅设备通过微创手术直接植入心脏，消除了心脏导线。因此，无铅起搏器减少了人们暴露于潜在的铅和感染相关并发症的风险，并在植入后提供了更少的限制和更短的恢复期。。

'Receiving CE Mark for AVEIR DR is a historic moment in European cardiac care. This technology redefines how we approach the treatment of heart rhythm abnormalities,' said Professor Reinoud Knops, M.D. PhD, from the department of cardiac electrophysiology at the Amsterdam University Medical Center. 'As the world's first dual chamber leadless pacemaker, AVEIR DR is a game changer, expanding our capacity to address complex heart conditions, and significantly reducing complication risk3 and enhance patient comfort.'.

“AVEIR DR获得CE标志是欧洲心脏护理的历史性时刻。阿姆斯特丹大学医学中心心脏电生理学系医学博士ReinoudKnops教授说，这项技术重新定义了我们如何治疗心律异常作为世界上第一个双腔无铅起搏器，AVEIR DR改变了游戏规则，扩大了我们应对复杂心脏病的能力，并显着降低了并发症风险3，提高了患者的舒适度。”。

Through Abbott's proprietary i2i™ (implant-to-implant) communication technology, AVEIR DR provides synchronized pacing between two leadless pacemakers on every heartbeat based on a person's clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body's blood between the paired, co-implanted devices.

通过雅培专有的i2i™（植入物到植入物）通信技术，AVEIR DR根据患者的临床需求，在每次心跳时提供两个无铅起搏器之间的同步起搏。i2i技术利用高频脉冲，通过配对的共植入设备之间身体血液的自然导电特性传递信息。

Conductive communication uses far less battery current than inductive, radio-frequency, or Bluetooth® communication, which are alternatives often used in implantable medical devices or traditional pacemakers..

导电通信比感应、射频或蓝牙®通信使用的电池电流少得多，而感应、射频或蓝牙®通信是植入式医疗设备或传统起搏器中常用的替代品。。

'Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization of two leadless pacemakers has been a significant challenge,' said Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer at Abbott's cardiac rhythm management business.

雅培（Abbott）心律管理业务部门负责医疗事务的副总裁兼首席医疗官伦纳德·甘茨（LeonardGanz）医学博士（M.D.）说，自成立以来，起搏器技术基本保持不变，因为两个无铅起搏器的无缝同步一直是一个重大挑战。

'AVEIR DR addresses a critical need for people living with slow heart rhythms and enhances people's quality of life with its revolutionary leadless design.'.

“AVEIR DR以其革命性的无铅设计满足了人们对缓慢心律的迫切需求，并提高了人们的生活质量。”。

The AVEIR DR i2i Global Clinical Investigation study showed that AVEIR DR met its three prespecified primary endpoints for safety and efficacy. Results through three-months post-implant showed a 98.3% system implant success rate and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally, despite different postures and gaits.4.

AVEIR DR i2i全球临床调查研究表明，AVEIR DR符合其安全性和有效性的三个预先设定的主要终点。结果植入后3个月，系统植入成功率为98.3%，超过97%的人成功实现了房室同步，因此尽管姿势和步态不同，上下腔仍能正常搏动。

The AVEIR DR leadless pacemaker system received U.S. FDA approval in June 2023.

AVEIR DR无铅起搏器系统于2023年6月获得美国FDA批准。

About Abbott:

关于雅培：

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..

雅培（Abbott）是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，拥有诊断、医疗器械、营养品和品牌仿制药领域的领先业务和产品。我们的114000名同事为160多个国家的人民服务。。