AstraZeneca Launches First Cardiovascular Medical Device in China, Offering Home-Based 12-Lead ECG Monitoring Solution

Source: JRJ.com.cn

Financial Jie Website News: April 28, 2020, Shanghai, China – Today, AstraZeneca officially announced its entry into the cardiovascular medical device sector, launching domestic sales of a medical-grade home-use 12-lead ambulatory electrocardiogram recorder (hereinafter referred to as the “12-lead ECG device”). Through this innovative pharmaceutical-device combined model, the company aims to further meet patients’ growing demand for home-based healthcare solutions.

The 12-lead electrocardiograph (ECG) device currently promoted by AstraZeneca is a product of the Kangnaixin brand (Model BEP186), manufactured by XinYunHengAn Medical Sci-Tech (Beijing) Co., Ltd. It is primarily designed to provide a comprehensive home-based ECG monitoring solution for patients following percutaneous coronary intervention (PCI). The Chinese Journal of Cardiology has previously stated that the long-term requirement in the clinical success criteria for PCI procedures is the sustained maintenance of short-term clinical success, with relief from symptoms and signs of myocardial ischemia lasting for more than six months. This criterion is established on the basis of scientific research. Studies have shown that even after PCI treatment, patients' risk of ischemic events continues to rise, with the 30-day postoperative readmission rate reaching as high as 10.8% [1]. Therefore, postoperative management for PCI patients is particularly important, and home ECG monitoring serves as an effective adjunctive tool in this regard.

Mr. Lai Minglong, General Manager of AstraZeneca China, stated: “AstraZeneca boasts over 40 years of global experience in the cardiovascular field. In China, we remain committed to a patient-centric approach, striving to build a comprehensive disease management platform for cardiovascular care that covers all stages of the disease continuum—from prevention and treatment to rehabilitation. By continuously introducing and developing high-quality products and innovative initiatives, we collaborate with partners across the board to establish an innovative healthcare ecosystem, contributing to the prevention and control of cardiovascular diseases in China and accelerating the arrival of the turning point in cardiovascular mortality.”

As the first pharmaceutical company to participate in the construction of Chest Pain Centers in China, and later to explore and implement the city-wide model for Chest Pain Centers, AstraZeneca has adhered to a patient-centric philosophy. In the cardiovascular field, it has consistently committed to building an innovative closed-loop platform for whole-course disease management, achieving significant progress and accomplishments in pre-hospital and in-hospital care. This time, targeting the post-discharge phase of whole-course management, AstraZeneca has incorporated 12-lead ECG devices and comprehensive home-based ECG monitoring solutions to enhance post-discharge patient management, thereby truly realizing a complete closed loop for patients with acute coronary syndrome (ACS, including myocardial infarction and unstable angina), spanning from pre-hospital emergency care and in-hospital treatment to post-discharge rehabilitation.

Mr. Chen Liheng, General Manager of XinYunHengAn, stated, “AstraZeneca is committed to providing comprehensive solutions for chronic disease management and contributing to the prevention and control of cardiovascular and metabolic diseases in China. This aligns closely with Kangnaixin’s vision of ‘bringing ECG machines into every household to make cardiac care more timely and effective.’ We believe that, leveraging AstraZeneca’s whole-disease-course management platform, Kangnaixin’s medical-grade home-use 12-lead ECG device will provide efficient and reliable cardiovascular health monitoring for users in need across China.”

The Kangnaixin 12-lead ECG recorder (Model BEP186) is specifically designed for home use. It not only effectively detects ECG abnormalities such as arrhythmias and myocardial ischemia, but also provides accurate early warnings for high-risk cardiovascular events, including acute myocardial infarction. This product holds a Class II medical device registration certificate, seven patents, and 16 software copyright registrations. In 2017 and 2019, it was awarded the Second Prize for Military Scientific and Technological Progress and the Second Prize for National Scientific and Technological Progress, respectively. XinYunHengAn Medical Sci-Tech (Beijing) Co., Ltd. is a pioneer in the new business model of wearable ECG monitoring within the “Internet + Healthcare” sector. Leveraging high-quality medical resources and a professional medical platform, the company holds multiple patented technologies in integrated fields such as mobile internet, healthcare management, artificial intelligence, and big data. It is committed to providing comprehensive solutions encompassing telemedicine, health management, and integrated diagnosis and treatment for individuals at potential risk of cardiovascular diseases as well as diagnosed patients.