Anastomotic Reinforcement Patch Approved for Marketing

  • 2022-09-02


Recently, the National Medical Products Administration has approved the registration of Anastomotic Reinforcement Patch, the innovative product manufactured by Beijing Biosis Healing Biological Technology Co., Ltd.

The anastomotic reinforcement patch includes tubular, flat and circular model. The tubular and the circular are composed of three parts, namely the patch, the backing and the traction stitch; the flat has only the patch. The patch is made of decellularized porcine intestinal submucosa, and is sutured and fixed to the backing with traction stitch. The flat patch has neither backing nor traction stitch.

This product is a degradable anastomotic reinforcement product. Its manufacturing process can remove the immunogenicity of animal tissue, while retaining the structure and bioactivity of the natural extracellular matrix; its structural design enables the product to be matched and connected to various models of staplers and improve operation safety. This product is, in combination with staplers, applied for reinforcement of anastomosis in distal gastrectomy, proximal gastrectomy, sleeve gastrectomy, gastrointestinal anastomosis. It is able to reduce anastomotic leakage, bleeding and other related complications after gastroenterectomy and bring the benefits to the patients.

The drug regulatory department will strengthen the post-marketing supervision of the product to protect the safety of medical device for the patients.