On May 11, 2023, the innovative product Self-expanding Radioactive Seed-Carried Biliary Stent of Rongsheng (Nanjing) Medical Technology Co., Ltd. is approved by NMPA. By far 200 innovative medical devices have been approved by NMPA.

The product consists of an internal and an external stent, each with a disposable introducer, and the external stent with a empty seed capsule. It combines radioactive seeds therapy with stent technology for the treatment of malignant biliary obstruction. The dual stent structure of the internal and external stent reduces the diameter of the external tube of the introducer, allowing for micro-invasive therapy and providing a vehicle for 3-dimensional intra-organ radiotherapy while expanding the stent.

This product is indicated for the dilation and treatment of biliary stricture or obstruction caused by malignant tumours that are inoperable or not surgically removed due to unwillingness. After implantation, the Self-expanding Radioactive Seed-Carried Biliary Stent can dilate the biliary stricture and the radioactive seeds carried on the stent can provide brachytherapy to the tumour tissue to inhibit tumour growth, which is expected to prolong the effective bile duct patency time and improve the survival time and life quality of patients. The marketing of this product will provide a new treatment option for patient.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.