Boston Scientific's SpyGlass Retrieval Basket Receives NMPA Approval in China, Introducing a Novel ERCP Solution for Biliary and Pancreatic Stone Removal

ShanghaiDecember 14, 2023PR Newswire -- Boston Scientific announces the launch of its SpyGlass Retrieval Basket, a disposable stone retrieval basket.^[1]Approved by the National Medical Products Administration in China. This product can be used to remove stones, stone fragments, or foreign objects from the pancreaticobiliary system under endoscopy, providing high-quality endoscopic diagnosis and treatment solutions for a large number of patients with pancreaticobiliary stones in China. The approval of the SpyGlass Retrieval Basket, a disposable stone retrieval basket as the latest addition to the full range of consumables in the SpyGlass DS system, marks the expansion of the SpyGlass series from diagnostic tools into the therapeutic field. It also signifies the further enrichment of Boston Scientific's product portfolio in the field of endoscopic interventions.

Hepatobiliary duct stone disease is a common biliary condition in China, characterized not only by complex conditions, treatment difficulties, and multiple complications, but also by a high rate of residual and recurrent stones post-surgery. Some patients even require multiple surgical interventions.^[2]Endoscopic Retrograde Cholangiopancreatography (ERCP) is a highly advanced minimally invasive endoscopic procedure that has been available for over 50 years, and has become an essential method for the diagnosis and treatment of biliary and pancreatic diseases. ERCP uses a duodenoscope to deliver instruments to the site of the lesion and performs diagnosis and treatment with the assistance of X-rays. Compared with traditional open surgery for stone removal, ERCP stone extraction does not require incisions, causes less trauma, and allows for quicker recovery, making it the first-line treatment for bile duct stones.^[3], and can also be used for pancreatic duct stone treatment.

However, approximately 10-15% of bile duct stones cannot be successfully removed using conventional ERCP techniques and are considered difficult bile duct stones.^[4], including excessively large stones, impacted stones, stones in special locations, postoperative residuals, and distal bile duct strictures^[2]Such conditions. The introduction of the SpyGlass Retrieval Basket, a disposable stone retrieval basket, has made it possible to remove refractory stones through ERCP. During application, this product can assist in clearing stones located in difficult positions such as intrahepatic bile ducts and pancreatic ducts, as well as small stone fragments after lithotripsy, thereby helping patients achieve single-session stone clearance and reducing the probability of repeat surgeries. Additionally, the basket surface features a Mediglide coating, which helps reduce friction and the force required for basket deployment and retrieval, thereby lowering the risk of complications.

Gong Wenhao, Senior Director of Boston Scientific China's Digestive and Respiratory Endoscopy Intervention Division and Technology Exploration, stated: "We are delighted to welcome another ‘valuable addition’ to our SpyGlass family, which is expected to bring good news to 4 million patients with biliary and pancreatic diseases in China."^[5]Previously, the SpyGlass DS Direct Visualization System has been nominated for the Galien Award, known as the "Nobel Prize of the pharmaceutical industry," and has already been launched in China for clinical use. The launch of the stone retrieval basket in China this time provides a new 'tool' for ERCP practitioners to improve surgical efficiency and enhance prognosis. Boston Scientific has long been committed to promoting the application and popularization of ERCP technology in China. In the future, we will continue to benefit primary healthcare through professional education, ensuring standardized ERCP techniques.

Note: The law requires that these devices be sold by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found on the product label or in the package insert. Products are for reference only and are not approved for sale in certain countries.
Product Name: SpyGlass Retrieval Basket Disposable Stone Retrieval Basket
Registrant/Manufacturer Name: Boston Scientific Corporation
Registration Certificate No.:CN Medical Device Registration Import 20232020565
EXP-PR-202312-0027/Version A/Effective Date: December 14, 2023, Expiration Date: December 14, 2025
© 2023 Boston Scientific or its subsidiaries. All rights reserved.

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About Boston Scientific Greater China

Boston Scientific set up its China headquarters in Shanghai in 1997 and currently has branches in Beijing, Guangzhou, Chengdu, Hong Kong, and Taipei. The company's core business areas cover cardiac intervention, structural heart disease, cardiac rhythm management, electrophysiology, endoscopic intervention, oncology intervention, peripheral intervention, urology, respiratory intervention, otolaryngology, and neuromodulation. Upholding the tradition of being an innovation leader, Boston Scientific is committed to becoming a medical technology company that meets the needs of doctors and patients, demonstrates innovative vitality, and commands respect by providing high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company’s website:www.bostonscientific.cn

[1] Registration Certificate Number:China Medical Device Registration No. 20232020565

[2] Biliary Surgery Group of Surgery Branch of Chinese Medical Association, Biliary Surgeons Committee of Surgery Branch of Chinese Medical Doctor Association. Expert consensus on the application of choledochoscopy in the diagnosis and treatment of hepatobiliary duct stones (2019 edition). Chinese Journal of Digestive Surgery, 2019, 18(7): 611-615.

[3] Endoscopy Branch of Chinese Medical Association. Consensus on Super-Minimally Invasive Diagnosis and Treatment Techniques for Chinese Oral Cholangiopancreatoscopy (2023, Beijing). Chinese Journal of Gastrointestinal Endoscopy Electronics, 2023, (4): 217-239.

[4] Parsi et al. Endoscopic management of difficult common bile duct stones. World J Gastroenterol 2013; 19(2): 165-173

[5] National Health Commission of the People's Republic of China. 2019 China Health Statistics Yearbook, Peking Union Medical College Press, 2019