Approval Granted For Stomach Bypass Stent System To Hit The Market

On January 17th, the NMPA approved the innovative product registration application for the Stomach Bypass Stent System

The product consists of a delivery system and a retrieval system. The delivery system comprises a delivery device, stomach bypass stent, and guide wire, with the stomach bypass stent pre-loaded into the delivery device’s storage tube. The retrieval system consists of a retrieval tube, retrieval hook, and retrieval cap. This product acts as an auxiliary lifestyle management tool during the bypass period, isolating food from contact with the intestines. It is designed for patients with obesity for whom lifestyle adjustments, non-invasive treatments, and inadequate results from drug therapies have proven ineffective.

Implanted with the assistance of a gastroscope in the duodenum and upper jejunum, the product achieves effects similar to gastric bypass surgery without altering the physiological structure of the gastrointestinal tract. By reducing the absorption of nutrients in the duodenum and upper jejunum, it aims to facilitate weight loss, offering a new option for the treatment of obesity.

The regulatory authorities will enhance post-market supervision of this product to ensure patient device safety.

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