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Hangzhou, China --- With Toumai^® Laparoscopic Surgical Robot (hereinafter referred to as “Toumai^®") independently developed by MicroPort^® Medbot, a robotics-specialized subsidiary of Shanghai MicroPort^® Medical (Group) Co., Ltd. (hereinafter referred to as "Microport^®"), the laparoscopic cholecystectomy was completed in Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine on October 21, 2019. This is the first operation completed by China's independently developed 3D electronic laparoscope, and it also marks that a prospective, multi-center, randomized controlled registered clinical trial to evaluate the clinical safety and effectiveness of DFVision^® 3D electronic laparoscope has been officially launched in China.

The registered clinical trial of DFVision^® was jointly implemented by Professor Zheng Minhua of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine and Professor Jiang Jianshuai of Ningbo First Hospital, with Professor Cai Xiujun of Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine as the main investigator. The surgery was performed by Liang Yuelong, associate chief physician of General Surgery Department of Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine. The patient, a 69-year-old male, was diagnosed as having developed gallstones when admitted to hospital. After discussion, the treatment team led by Dr. Liang Yuelong decided to perform laparoscopic cholecystectomy during the day. The patient was randomly assigned to the experimental group before operation, and the surgery was completed by DFVision^®, with a smooth process. The patient was in stable condition after surgery and was discharged from hospital on the same day.

After the operation, Dr. Liang Yuelong commented on the DFVision^®: "The 3D imaging effect and image quality of DFVision^® have reached the international leading level, and the optimized design of its scope has significantly improved the operating experience of operating surgeon. From the viewpoint of operating experience and surgical effect, it reveals the first-class standard, and will bring more choices to Chinese doctors and patients.

Since Mouret, a French doctor, completed the first laparoscopic cholecystectomy in 1987 and started the era of modern laparoscopic surgery [1], the concept of minimally invasive treatment represented by laparoscopic technology has spread rapidly around the world. It uses electronic and optical equipment to complete complex surgery through small holes. Compared with the traditional open surgery, it is superior in safety, efficiency, faster recovery, less complications during and after operation, and beautiful wound. The visual field of traditional 2D laparoscopic surgery is a plane image. Because of the lack of perception of depth, the surgeon can only judge the depth of field according to such perception factors as laparoscopic movement, anatomical structure size, texture gradient, line perspective, defocus blur, etc. Thus, the surgeon is required to have rich surgical experience and skillful operation skills and needs a long learning curve to master the device skillfully. The rapid development of three-dimensional laparoscopy in recent years has effectively solved the above problems.

At present, the 3D optical laparoscopic system is still the international mainstream product, and only a few laparoscopic manufacturers can provide such products. There is no domestic 3D electronic laparoscopic product in the market of China. The DFVision® 3D Electronic Laparoscopic System, which was used for completing the first clinical surgery, was independently designed and developed by Microport^® Medbot, and is expected to become the first domestic 3D electronic laparoscopic system that has been certified and marketized in China. Compared with the traditional 2D laparoscopy, it provides the operator with a 3D sense of the surgical field and a sense of the depth of the surgical operation by means of two-way image acquisition, which is very important for the operator to complete fine directional operations through the laparoscopic system, such as manual suture operation, fine anastomosis operation and functional reconstruction, as well as hand-changing and knotting operations of needle-holding instruments. The view closer to stereoscopic vision brings the surgeon more surgical convenience, shorter learning curve, and easier command of the device, especially for those who have no experience in laparoscopic surgery [2]. Microport^® Medbot has focused on the clinical needs during the R&D process. In the application of the high resolution structural program of high-resolution imaging objective lens and electronic mirror, while ensuring the full HD rendering of dual-channel images, it abandons the huge optical mechanism of traditional laparoscope with the lens body weight significantly reduced, which not only perfectly presents the anatomical level of human organs to meet the operator's demand for accurate identification of tissue details, but also significantly optimizes the operator's operating experience.

DFVision^® 3D Electronic Laparoscopic System officially entered the "Special Procedure for Review of Innovative Medical Devices" of the National Medical Products Administration on April 16, 2019. The successful completion of the first operation in the registered clinical trial will speed up the process of its marketization in China, which is expected to benefit more patients in the near future. Dr He Chao, General Manager of Microport^® Medbot, said: "At present, there are no domestic 3D electronic laparoscopic products on the market, and the domestic market is monopolized by foreign manufacturers. I believe that in the near future, with the certification and marketization of domestic 3D electronic laparoscopic products, while popularizing the international cutting-edge clinical technology and promoting the development of domestic related industries, the national medical expenditure and the economic burden of patients will be reduced significantly. As a leader of high-end innovative medical solutions, we will continue to develop and provide benefit-all integrated solutions to patients and doctors in China and even the world in the field of microtrauma treatment."

References:
[1]Wu Mengchao et al. Huang Jiasi Surgery (7th Edition), People's Medical Publishing House, 2008
[2]Laparoscopic and Endoscopic Surgery Group, Surgical Society of Chinese Medical Association. Expert Consensus on 3D Laparoscopic Surgery Technology (2015). Chinese Journal of Practical Surgery, 2015,35(9):967-969