Recently, the innovative product Gastric Bypass Stent System of Hangzhou Tongee Medical Technology Co., Ltd. was approved by China NMPA.
This product consists of a delivery system and a retrieval system. The delivery system includes a delivery device, a gastric bypass stent and a guide wire, with the gastric bypass stent pre-loaded into the storage tube of the delivery device. The retrieval system includes a retrieval tube, a retrieval hook and a retrieval cap. This product isolates the contact between chyme and intestinal tract. As an assisted lifestyle product for weight management during bypass, it is used for patients with obesity associated with ineffective lifestyle modification, poor response to non-invasive treatment and drug treatment.
This product is placed in the duodenum and upper jejunum assisted by gastroscope and can achieve the effect similar to gastric bypass without changing the physiological structure of gastrointestinal tract, reducing the absorption of nutrients in food by most tissues of duodenum and jejunum to achieve the purpose of weight loss, and providing a new option for the treatment of obesity.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.