Boston Scientific's WATCHMAN FLX™ Left Atrial Appendage Closure Device Successfully Implanted for the First Time in Mainland China
Boston Scientific
Medical Device Manufacturer
Bringing More Diverse Options for Stroke Prevention
ShanghaiMay 25, 2022PR Newswire -- Today, Boston Scientific Corporation (NYSE:BSX), a global leader in innovative medical technology, announced its latest generation of left atrial appendage closure devices.[1]WATCHMAN FLX™Successfully completed the first implantation in mainland China in Shanghai. This marks the official launch of the product in clinical use in mainland China, which will bring more diverse treatment options for stroke prevention in Chinese patients with atrial fibrillation and help reduce the burden of cardiovascular and cerebrovascular diseases in China.
Ge Junbo, an academician of the Chinese Academy of Sciences and director of the Cardiology Department at Zhongshan Hospital Affiliated with Fudan University, led the team in completing this first implantation surgery. After the procedure, Academician Ge stated: "As the aging population continues to accelerate, China faces increasing challenges in the comprehensive management of atrial fibrillation (AF) and in reducing the incidence and mortality rates of stroke. Left atrial appendage occlusion is precisely a preventive procedure that can eliminate the 'threat' of stroke for AF patients, thereby shifting disease management upstream and contributing to the establishment of a healthcare and disease prevention system that emphasizes prevention, treatment, and management equally."
Academician Ge Junbo (second from the right) provides on-site guidance for the first WATCHMAN FLX(TM) implant surgery in mainland China
During the surgery, Tucson Medical Center in Tucson, Arizona, USA, as the current global multiple WATCHMAN FLX™One of the main participating centers in the clinical study, Professor Thomas Waggoner, Director of the Interventional Cardiology Research Program, participated in the pre-operative and intra-operative discussions via video conference.
About the Latest Generation of Left Atrial Appendage Occluder WATCHMAN FLX™Officially launched in mainland China for clinical application, Academician Ge Junbo stated: "From the initiation of the first human implantation study of the global WATCHMAN in 2002 to this year, it has been a full 20 years. Its long-term efficacy and safety have been confirmed by research data and widely recognized by experts. The latest generation WATCHMAN FLX™The development and market launch of this product have been fully validated in real-world studies for safety, sealability, and ease of use. Its application in clinical practice in China will provide a safer and more effective technical guarantee for the further advancement of left atrial appendage closure technology in China; it will offer cardiologists a safer and more flexible surgical experience, ultimately bringing greater benefits to patients with atrial fibrillation.。"
Postoperative group photo of Academician Ge Junbo (center) and his team
Evidence-Based20Year, Pioneering New Approaches in Stroke Prevention
In China, at least one out of every five deaths is caused by stroke.[2]. The stroke risk in patients with atrial fibrillation is five times higher than that of the general population.[3], as high as 20-30%. Compared with strokes caused by other reasons, strokes caused by atrial fibrillation are characterized by "high disability rate, high mortality rate, and high recurrence rate," bringing tremendous suffering to patients and their families. In non-valvular atrial fibrillation, over 90% of thrombus formation is related to the left atrial appendage.[4]。
To address the challenge that patients with atrial fibrillation are prone to developing blood clots in the left atrial appendage, which can lead to strokes, Boston Scientific introduced WATCHMAN, the first left atrial appendage closure device for clinical use in China. By occluding the left atrial appendage, WATCHMAN helps non-valvular atrial fibrillation patients effectively prevent strokes and reduces their lifelong dependency on oral anticoagulants. As an innovative "tool" for stroke prevention in atrial fibrillation, this product won the Galien Award, known as the "Nobel Prize of the pharmaceutical industry," in 2018. Since its first application in humans in 2002, WATCHMAN has accumulated 20 years of clinical evidence, with over 200,000 procedures performed globally and nearly 30,000 in China, demonstrating its extensive clinical experience and recognized scientific reliability.
Dedicated Upgrade, Safe and Effective Occlusion Further Enhanced
Completed the first WATCHMAN FLX implantation in China today™Is another groundbreaking left atrial appendage occluder developed by Boston Scientific, which has just been nominated for the 2022 Prix Galien Award for "Most Innovative Medical Technology."
As the latest generation product, WATCHMAN FLX™The外形结构, 骨架技术, 锚定钩设计, 材料工艺, and many other details of the occluder have been improved, making it suitable for various types of left atrial appendage morphologies in clinical practice and increasing the success rate of occlusion. It also features excellent maneuverability for easy insertion and retrieval, further enhancing the safety of the procedure. According to real-world research data released at the 2022 Cardiovascular Research Technologies (CRT) conference in the United States, the WATCHMAN FLX™The proportion of surgery-related serious adverse events was 0.37%, with a success rate as high as 98%.[5]. Previously, the PINNACLE study also showed that WATCHMAN FLX™At 45 days post-operation, the discontinuation rate of oral anticoagulants among patients was as high as 96.2%, and the success rate of occlusion at one-year follow-up was 100%.[6]It can be said that WATCHMAN FLX has pushed the safety, effectiveness, and maneuverability of occluders to a higher standard.
Zhang Jun, President of Boston Scientific Greater China, said: "The next-generation left atrial appendage closure device WATCHMAN FLX™The first successful implantation in mainland China is another testament to Boston Scientific's commitment to its mission of "Innovation for Life." Boston Scientific has long been dedicated to bringing efficient and suitable minimally invasive solutions to Chinese patients, and we look forward to the WATCHMAN FLX.™"This formal entry into clinical use will benefit more Chinese patients with atrial fibrillation, contributing to the construction of a future with universal health and the realization of the 'Healthy China 2030' plan."
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 over four decades, Boston Scientific has consistently led the global medical technology industry by providing a wide range of high-performance medical solutions to meet the urgent healing needs of patients and reduce healthcare costs. For more detailed information, please visit the company 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 businesses encompass interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology and pelvic health, respiratory products, and more. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that meets the needs of doctors and patients, demonstrates innovative vitality, and delivers high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company website:www.bostonscientific.cn
[1]CN Medical Device Registration No. 20223030126
[2]Chinese Stroke Association. China Stroke Report 2019. China Stroke Journal[J]. 2020.10(15):1037-1043
[3] Heart Disease and Stroke Statistical Update: 2009 Update Circulation 1-27-09; AHA Statistical Update: Heart Disease and Stroke Statistics-2008 Update
[4] Blackshear JL. OdellJA., Annals of Thoracic Surgery. 1996; 61:755-759
[6] Doshi S. Primary Outcome Evaluation of a Next Generation LAAC Device: The PINNACLE FLX Trial. Presented at HRS 2020 Science