Boston Scientific Announces MRI-Compatible ICD and CRT-D Devices Approved in China, Enhancing Patient Access to High-Quality Care

Shanghai, November 16, 2021 /PR Newswire/ -- Recently, Boston Scientific announced that its Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) products have received Magnetic Resonance Imaging (MRI) conditional labeling approved by the National Medical Products Administration (NMPA). This will provide more "comprehensive" protection for a wide range of arrhythmia patients in China: allowing for MRI scans while broadening disease diagnosis and treatment options, ultimately enhancing overall health management.

Currently, cardiovascular disease has become the leading cause of death among residents in China. According to the "Report on Cardiovascular Health and Disease in China 2020," the number of people suffering from cardiovascular diseases in China is approximately 330 million, with a rising mortality rate. Among them, 8.9 million people are affected by heart failure, and cases of sudden cardiac death are showing a trend of affecting younger individuals.^[1]. Implantable Cardioverter Defibrillator (ICD) is an effective and common interventional method for preventing sudden cardiac death. For high-risk patients with heart failure combined with the risk of sudden death, Cardiac Resynchronization Therapy Defibrillator (CRT-D) can significantly improve the patient's symptoms, enhance their quality of life, and reduce heart failure hospitalization rates and all-cause mortality.^[2],[3]

In the past, when cardiovascular disease patients suffered from other diseases and needed precise imaging diagnosis through magnetic resonance imaging (MRI), they were unable to undergo the examination due to implanted metal devices such as ICDs or CRT-Ds. With the continuous growth of China's aging population, chronic diseases are also increasing gradually with age. The application of MRI has become very widespread, especially in areas like cardiovascular and cerebrovascular diseases, bone and joint disorders, and tumors, where it has become an important diagnostic tool. However, the diagnostic limitations caused by implanted ICD and CRT-D devices have also become a major challenge for clinical practice.

Based on the actual needs of patients in China, the Boston Scientific MRI-compatible ICD/CRT-D products approved this time will provide patients with solutions adaptable to a wider range of medical scenarios. While offering protection for patients with arrhythmia, these products also accommodate the clinical need for MRI scans, creating conditions for patients to receive timely and precise treatment.

Ms. Zhang Jun, President of Boston Scientific Greater China, stated: "In the field of sudden cardiac death prevention, Boston Scientific not only has a comprehensive product portfolio but also continues to innovate based on patients' clinical needs, developing more tailored products for clinical use." She emphasized, "Innovating for life is the enduring初心 (note: '初心' could be translated as 'original aspiration') and vision of Boston Scientific. In the future, the company will continue to intensify the introduction of innovative technologies and products, bringing more minimally invasive interventional solutions that improve the quality of life to Chinese doctors and patients, enabling more patients to enjoy high-quality medical services, thereby contributing to the construction of Healthy China."

^[1]China Cardiovascular Health and Disease Report 2020

^[2] Bristow MR, et al. N Engl J Med. 2004; 350:2140-2150

^[3] Cleland JG, et al. N Engl J Med. 2005; 352:1539-1549

About Boston Scientific

Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients worldwide. For more than four decades, Boston Scientific has consistently led the development of the global medical technology industry by delivering a wide range of high-performance medical solutions. These solutions address critical treatment needs for a broad patient population while reducing healthcare costs. For more detailed information, please visit the company's website:www.bostonscientific.cn

About Boston Scientific Greater China

Boston Scientific established its China headquarters in Shanghai in 1997 and currently has branch offices in Beijing, Shanghai, Guangzhou, Chengdu, Hong Kong, and Taiwan. The company's core business areas include interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology and pelvic floor health, respiratory products, and more. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that addresses the needs of doctors and patients, with a focus on innovative vitality by providing high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company website:www.bostonscientific.cn