Boston Scientific and Boao Super Hospital Launch Real-World Data Study for EXALT Model D Single-Use Duodenoscope
Boston Scientific
Medical Device Manufacturer
Boao, HainanApril 10, 2020 /PRNewswire/ -- Today, Boston Scientific Corporation (NYSE: BSX) made its debut at the "Healthy Hainan - Lecheng Tour" and the "Never-Ending" International Pharmaceutical and Medical Device Exhibition (hereinafter referred to as the "Pharmaceutical and Medical Device Exhibition"), showcasing its cutting-edge solutions across seven therapeutic areas. On the same day, Boston Scientific and Boao Super Hospital jointly launched a real-world data study on the EXALT Model D* single-use duodenoscope, aiming to accelerate the adoption of this innovative sterile device in the Boao Lecheng International Medical Tourism Pilot Zone, thereby benefiting Chinese patients at an earlier date, supporting the zone’s reforms, innovations, and pioneering initiatives, and fully aligning with the national strategy for the development of the Hainan Free Trade Port.
Gu Gang, Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, stated at the pharmaceutical and medical device exhibition that this exhibition,at the critical moment of resuming work and production nationwide and in Hainan, a significant initiative launched in Hainan Province. This year also marks the inaugural year of the Hainan Free Trade Port construction. As one of the key industrial parks within this framework, Boao Lecheng aims to leverage this opportunity to demonstrate the open mindset of the Lecheng Pilot Zone and its innovative approach to institutional and mechanistic reforms.
Boston Scientific’s product undergoing real-world data studies in Boao Lecheng, the EXALT Model D, is the world’s first single-use duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP).[1], approved by the U.S. Food and Drug Administration (hereinafter referred to as the FDA) in December 2019, and granted “Breakthrough Device Designation” by the FDA”[2]This product is not yet available in mainland China. This pioneering device is designed to replace reusable duodenoscopes. By eliminating the need for reprocessing and repair of duodenoscopes, it ensures that patients receive a brand-new, sterile instrument during procedures, thereby avoiding the risk of potential iatrogenic infections. This is particularly critical for surgical operations during the novel coronavirus pandemic, marking a significant advancement in endoscopic technology.
Academician Li Zhaoshen of the Chinese Academy of Engineering stated that, in light of the severe global spread of the COVID-19 pandemic, greater attention should be paid to the issue of cross-infection in healthcare settings. The use of single-use medical devices in clinical practice will bring substantial improvements to preventing iatrogenic infections, offering new insights and approaches for endoscopic procedure protection in the post-pandemic era. It is hoped that the real-world data study currently being conducted will accelerate the regulatory approval process for this product, enabling more patients in China to benefit from it at an earlier stage.
Fang Pihua, Executive Vice President of Boao Super Hospital, stated that the hospital has assembled advanced domestic specialized technologies and expert teams. It has introduced more than ten leading innovative medical devices and pharmaceuticals from both China and abroad, completed numerous complex treatments, and pioneered many first-of-their-kind procedures. The Super Hospital looks forward to conducting real-world data studies in collaboration with Boston Scientific, thereby expanding the scope and volume of use of internationally advanced pharmaceuticals and medical devices to benefit patients in China.
At this international medical device exhibition, Boston Scientific showcased 24 innovative medical device products spanning seven key areas: interventional cardiology, structural heart disease, peripheral and oncology interventions, endoscopic interventions, urology and pelvic health, cardiac rhythm management and electrophysiology, and neuromodulation. Among these were six products that have either won or been nominated for the Galen Prize, often referred to as the "Nobel Prize of the pharmaceutical industry."
Notably, the Rezum water vapor thermal therapy* device for treating benign prostatic hyperplasia (BPH), which has not yet been launched in mainland China, has attracted significant attention from industry professionals. Data shows that over 50% of men aged 60 and above worldwide suffer from benign prostatic hyperplasia.[3], Rezum water vapor thermal therapy utilizes the heat from water vapor to rapidly reduce prostate volume, improving symptoms such as difficulty in urination, with an average procedure time of 8 minutes.[4], day-case surgeries suitable for implementation in outpatient clinics and community hospitals. Leveraging advantages such as short operative time, rapid recovery, and high safety profile, this technique not only alleviates the disease burden among the vast population of middle-aged and elderly patients with benign prostatic hyperplasia (BPH), but also fully enhances the utilization efficiency of primary healthcare resources, facilitates the decentralization of medical services, and supports the advancement of the tiered diagnosis and treatment system.
Ms. Zhang Jun, President of Boston Scientific’s Greater China region, stated that as a company committed to “innovating for life,” Boston Scientific not only focuses on deepening technological innovation but also strives to explore model innovations in collaboration with the Chinese government and local ecosystem partners, thereby contributing to the “Healthy China” initiative. With the implementation of several significant policies, the Hainan Free Trade Port is emerging as a new highland for medical innovation practices. Boston Scientific will continue to work hand in hand with the Boao Lecheng International Medical Tourism Pilot Zone, introducing more world-leading minimally invasive interventional products while promoting the transformation, upgrading, and coordinated development of the healthcare industry, thus supporting the robust growth of China’s broader health sector.
*This product is not yet available in mainland China
[3] Bin LK. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. Elsevier Ltd. 2017;4(3):148–51.
[4] Zachary Green. What’s New in Rezum: a Transurethral Water Vapour Therapy for BPH. Current Urology Reports (2019) 20:39.
About Boston Scientific
Boston Scientific Corporation is committed to innovating for life. We are dedicated to developing innovative medical solutions that improve the lives of patients worldwide. For more than 40 years, Boston Scientific has been a leader in the global medical technology industry, offering a broad portfolio of high-performance medical solutions to meet the urgent therapeutic needs of patients and reduce healthcare costs. For more 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 maintains 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 interventions, peripheral and oncology interventions, urology and pelvic health, and respiratory products. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a patient- and physician-centric, innovative, and respected medical technology company by providing high-quality medical products and services for prevention, diagnosis, and treatment. For more information, please visit the company’s website:www.bostonscientific.cn