Boston Scientific’s WATCHMAN FLX™ Animal Study Training Workshop Held at Guorui Xin Chuang
Release time:
2024-04-16 14:51
Keywords:
Science,Medical
On April 13, 2024, the Boston Scientific WATCHMAN FLXTM Animal Study Training Workshop was held at Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. This training session was the third of 2024, and its participants were primarily cardiologists from Guangdong, Zhejiang, Jiangsu, Shandong, Henan, Qinghai, Inner Mongolia, Chongqing, Jiangxi, Guizhou, Gansu, Ningxia, and Shaanxi provinces.
Professor Zhang Yushun shares WATCHMAN FLX Single-center experience
Professor Li Yaodong’s Introduction WATCHMAN FLX Operation Procedure
Teacher Du Yajuan explains. TEE At WATCHMAN FLX LAAC Application in surgery
Introduction by Teacher Yang Xiaomi, Technical Support for the Northwest Region at Boston Scientific WA TCHMAN FLX Redefining the Standard for Ideal Occluders
Regarding the Left Atrial Appendage Closure Device WATCHMAN FLX™
According to the Boston Scientific website, Boston Scientific, a globally leading innovative medical technology company, has... 2022 Year 05 Moon 25 Announced today that its next-generation left atrial appendage occluder is now available. WATCHMAN FLX™ The first implantation in mainland China has been successfully completed in Shanghai. This marks the official launch of the product in mainland China and its entry into clinical use, bringing more diversified treatment options for stroke prevention to Chinese patients with atrial fibrillation and helping to alleviate the burden of cardiovascular and cerebrovascular diseases in our country.
Academician Ge Junbo, an academician of the Chinese Academy of Sciences and Director of the Department of Cardiology at Zhongshan Hospital affiliated with Fudan University, led his team in performing this first-ever implantation procedure. After the surgery, Academician Ge Junbo stated: “As China’s population continues to age at an accelerating pace, we are facing ever-greater challenges in the comprehensive management of atrial fibrillation and in reducing the incidence and mortality rates of stroke. Left atrial appendage closure is precisely such a preventive procedure that can effectively ‘lift the alarm’ for stroke risk in patients with atrial fibrillation, thereby shifting disease management upstream and helping to build a healthcare and disease-prevention system that emphasizes both prevention and treatment.”
Academician Ge Junbo (second from right) provides on-site guidance. WATCHMAN FLX(TM) First implant surgery in mainland China
On the latest-generation left atrial appendage occluder WATCHMAN FLX™ Officially launched in mainland China for clinical use, Academician Ge Junbo stated: " Since 2002 Yearly global WATCHMAN The first human implantation study has now reached its full year of operation. 20 The latest generation has had its long-term efficacy and safety confirmed by research data and widely recognized by experts. WATCHMAN FLX™ The research and launch of this product have been thoroughly validated by real-world studies in terms of safety, sealing performance, and ease of use. Its clinical application in China will provide a safer and more effective technological foundation for the further development of left atrial appendage closure techniques in China. It will also offer cardiologists a safer and more flexible surgical experience, ultimately bringing greater benefits to the vast number of patients suffering from atrial fibrillation. "
A group photo of Academician Ge Junbo (center) and his team after the surgery.
About Boston Scientific
Boston Scientific is committed to innovating for life, dedicated to developing innovative medical solutions that improve the lives of patients worldwide. For more than four decades, Boston Scientific has consistently been at the forefront of the global medical technology industry, providing a wide range of high-performance medical solutions that address the urgent healing needs of patients and help reduce healthcare costs.
About Guorui Xinchuang
Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices, established on... 2020 Year 06 Yue was registered and established in Kongxin New City. It is currently a comprehensive medical device safety evaluation institution in the northwest region, primarily providing product safety evaluation services to R&D companies of Class II and Class III medical devices. Guorui Xinchuang has already purchased Siemens equipment. DSA Experimental equipment and instruments, including digital subtraction angiography machines, Youwo high-pressure injectors for angiography, Mindray respiratory anesthesia machines, and Huitong high-frequency electrosurgical units. Since the laboratory’s establishment, nearly... has been invested in its development. 2000 With the completion of multiple batches of trials, the laboratory has rapidly enhanced its national and international reputation and influence, solidifying its position as a domestic leader in preclinical large-animal studies for medical devices.
As an important intermediate link in the transformation of innovative medical devices from the innovation chain to the industrial chain, medical device safety evaluation research bridges the interaction and integration between the innovation chain and the industrial chain in the life sciences sector under the Qin Chuang Yuan initiative. This research holds significant value for the development of the province’s life sciences industry.
Guo Rui Xin Chuang at 2021 Year 03 The license for the use of laboratory animals, issued by the Shaanxi Provincial Department of Science and Technology, makes us the only entity in our province to comply with... GLP Preclinical evaluation laboratory for medical devices in operation. At 2022 Year 07 The company has been awarded the National High-Tech Enterprise Certificate and currently holds 6 A computer software copyright.
Guorui Xin’s business scope:
- For the National Medical Products Administration ( NMPA The Medical Device Technical Review Center provides preclinical animal studies and reports required for medical device registration.
- For the United States FDA and the European Union ( OECD ) The certification provides preclinical animal studies and reports required for medical device registration.
- We provide preclinical large-animal studies for the R&D phase of medical devices to innovative medical device companies, R&D institutions, and research institutes.
- Providing technical training and promotion services for the clinical application of medical devices to innovative medical device companies, R&D institutions, and hospitals.
- Establishment of various innovative animal models for basic research: experimental animal models for conditions such as myocardial infarction, heart failure, and fractures (including both large and small animals).
- Evaluation reports for medical device products or projects—covering government project support, investment fund consulting, and the initiation of R&D enterprise projects.
- In vitro simulation platform testing and reporting for medical devices during the R&D and registration phases.
- Clinical trial protocol development and consulting services based on physician teams and animal studies.
- Medical knowledge training and courseware development related to medical device R&D.
- Medical device testing and clinical new technology training based on ex vivo organs.
- Joint application for medical device R&D innovation projects at the national, provincial, and park levels.
- Physician-led innovative design and industrialization services for patent commercialization.
- Product R&D Evaluation and Improvement & Optimization Report Based on Large Animal Studies.
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