EndoFresh®: China's First Fully Disposable Electronic Gastroscope Pioneers a New Era in Gastrointestinal Endoscopy
On March 17, 2022, the domestically self-developed disposable electronic gastroscope product “EndoFresh”®“Obtained the medical device registration certificate issued by the Guangdong Provincial Medical Products Administration, becoming the world’s first disposable electronic gastroscope product to simultaneously hold CE, FDA, and NMPA certifications. EndoFresh”®The disposable electronic gastroscope, released by Xianzan Technology, has received approval from the National Medical Products Administration (NMPA), signaling an innovative breakthrough for domestically developed medical devices in the endoscopy field and bringing benefits to Chinese patients.
Cleaning and disinfection of traditional reusable endoscopes represent a major pain point in clinical practice. Due to their complex structure, reusable endoscopes are difficult to clean and disinfect thoroughly, posing a risk of cross-infection between patients during clinical diagnosis and treatment. The ECRI Institute has listed the infection risk associated with endoscopes among its “Top 10 Health Technology Hazards” for more than ten consecutive years. In contrast to reusable endoscopes, single-use endoscopes eliminate the need for reprocessing, thereby eradicating the risk of cross-infection. They are more suitable for use in populations at risk of infection control issues and demonstrate greater development potential in certain specialized scenarios.
Currently, a variety of single-use endoscope products have been applied in clinical practice in the fields of pulmonology and urology. Boston Scientific launched its single-use flexible ureteroscope in 2016 and its single-use duodenoscope in 2019, while Ambu introduced its single-use bronchoscope in 2013 and its single-use cystoscope in 2020. The fully disposable EndoFresh has recently obtained registration certification from the National Medical Products Administration (NMPA).®Disposable electronic gastroscope effectively fills the gap in China’s disposable endoscopy market within the gastroenterology sector.
During the 2021 Digestive Disease Week (DDW) in the United States, at an online satellite symposium themed “Clinical Application and Prospects of Single-Use Digestive Endoscopes During the Pandemic,” dozens of domestic and international experts shared their experiences with EndoFresh.®Feedback on Clinical Trials and Product Trials: Positive Endorsement of the Product, with Recognition of EndoFresh®Disposable single-use digestive endoscopes, represented by EndoFresh, can prevent iatrogenic cross-infection and meet the clinical needs of multi-scenario applications, especially in the context of the global COVID-19 pandemic.®“Fully disposable endoscopes,” represented by this model, hold broad market prospects.
In April 2020, the Chinese Society of Gastroenterology of the Chinese Medical Association released the Expert Consensus on Diagnosis and Treatment of Digestive System Involvement in COVID-19, which explicitly stated that confirmed or suspected COVID-19 patients should be scheduled for endoscopic procedures in dedicated endoscopy rooms. Capsule endoscopes or single-use endoscopes, which do not require cleaning or disinfection and thus reduce exposure to contaminants, may be selected for patients with indications for endoscopic evaluation.
EndoFresh, which has obtained the registration certificate this time®Disposable electronic gastroscope is primarily used for endoscopic examination, diagnosis, and treatment of the upper gastrointestinal tract. For patients, it ensures a one-scope-per-patient protocol, eliminating cross-infection risks, enabling immediate availability, and reducing waiting times. For physicians, the device is discarded after use, eliminating the need for reprocessing and significantly enhancing endoscopic diagnostic and therapeutic efficiency. In special scenarios such as emergency settings, intraoperative procedures, field combat readiness, and bedside care, disposable endoscopes leverage their flexibility to play a unique role.
The multicenter registration clinical trial for the fully disposable EndoFresh® electronic gastroscope is a randomized, parallel-controlled, non-inferiority clinical trial jointly led by President Zhang Shutian of Beijing Friendship Hospital, Capital Medical University (National Clinical Research Center for Digestive Diseases), and Director Wang Bangmao of the Department of Gastroenterology at Tianjin Medical University General Hospital. The trial results confirmed that EndoFresh®Disposable electronic gastroscopes are safe and effective in clinical practice, effectively meeting clinical needs (under review).
In addition, the fully disposable EndoFresh®Multiple clinical trials of disposable electronic gastroscope are being conducted in hospitals across China. The clinical trial directions include routine clinical diagnosis and treatment, emergency/bedside and other medical scenarios. Some research articles have been submitted for publication or are in the process of writing. As of February 2022, several research articles have been published in top journals such as the Chinese PLA Medical Journal and Digestive Endoscopy.
Disposable EndoFresh®The design, handling, functionality, and performance of disposable electronic gastroscope bodies are comparable to those of commonly used reusable gastroscopes, with performance parameters on par with products from the three major traditional manufacturers of reusable endoscopes. Furthermore, EndoFresh®’s product series has established a robust patent protection portfolio, currently holding nearly 200 patents.
EndoFresh®Development History of the Disposable Electronic Gastroscope System
Product Features
● High-definition images, true-to-life reproduction
● Integrates light source, auxiliary water supply, and suction functions in a single unit for easier installation
● Portable and easy to move, adaptable to more clinical scenarios (emergency, bedside, intraoperative, etc.)
● Single-patient, single-use; discard after use
● No decontamination required, no maintenance needed
● Flexible operation with a 3.0 mm instrument channel
EndoFresh®Disposable electronic gastroscope released by Huizhou Xianzan Technology Co., Ltd. Huizhou Xianzan Technology Co., Ltd. is a wholly-owned subsidiary of Shenzhen Xianzan Technology Co., Ltd. Daichuan Medical, also under the Shenzhen Xianzan umbrella, obtained EndoFresh in September 2020®FDA registration certificate for the electronic endoscope image processor. The fully disposable single-use electronic colonoscope is currently under NMPA registration review and is expected to be approved in the near future.
