Shanghai, China – On April 16, 2019, MicroPort MedBot (Shanghai) Co., Ltd. (“MicroPort® MedBot”), which is a subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”), successfully applied for the entry of its independently developed 3D electronic laparoscope into the Special Review and Approval Procedure for Innovative Medical Devices (“Green Path”) with National Medical Products Administration of China (NMPA). By far, a total of 16 products of the subsidiaries of MicroPort® or its related companies have been granted entries into the Green Path.
Currently, 3D optical laparoscopes are mainstream internationally, with only a fraction of the laparoscope producers marketing 3D electronic laparoscopes. There is no 3D optical laparoscopes of domestic brands in the Chinese market, let alone 3D electronic ones. The 3D electronic laparoscope approved to enter the Green Path is independently designed and developed by MicroPort® MedBot, with the prospect of becoming the first Chinese-made 3D electronic laparoscope to obtain registration certificate. Compared to conventional 2D laparoscope, it uses dual image acquisition to provide surgeons with a three-dimensional vision and perception of depth during operations, which plays a highly important part in helping with the fine operations under laparoscope, such as hand-sewn operations, fine anastomosis and function reconstruction, in addition to hand switch of needle instrument and knotting. Meanwhile, by taking advantage of a vision closer to three-dimensional real situation, surgeons have more convenience in operations and shorter learning curves, which makes the 3D electronic laparoscope easier to master for the surgeons without any previous experience with laparoscopes [1]. MicroPort® MedBot closely pursues clinical needs during R&D, in that the application of an independently designed solution of high-definition objective lens and chip-on-tip structure ensures full high-definition output of dual image and gets rid of the huge optical structure of conventional laparoscopes to substantially reduce lens weight at the same time. As a result, not only surgeons’ needs for precious identification of tissue details are satisfied, but the intraoperative grip experience is also optimized significantly.
A prospective, multi-centered and randomized controlled registration trial will kick off shortly in China to evaluate the safety and efficacy of the 3D electronic laparoscope. As there is no Chinese-made 3D laparoscopes for sales in China, the entry of MicroPort® MedBot’ 3D electronic laparoscope into the Green Path is set to speed up its progress to launch in China. Also, it will play a positive part to bring internationally cutting-edge technologies to clinicians and promote the development of relevant industries in China, with more patients expected to be benefitted in the near future.
Reference:
[1] Laparoscopic and Endoscopic Surgery Group of Chinese Society of Surgery, 3D Laparoscopic Skills Expert Consensus (2015). Chinese Journal of Practical Surgery, 2015,35(9):967-969