News-MD
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.
吻合口加固修补片获批上市
双语新闻
近日，国家药品监督管理局经审查，批准了北京博辉瑞进生物科技有限公司生产的创新产品“吻合口加固修补片”注册。
吻合口加固修补片共包含管状型、平片型、圆型。管状型和圆型由修补片、背衬、牵引线三部分构成，平片型只有修补片。修补片由脱细胞猪小肠粘膜下层材料制备而成，与背衬用牵引线进行缝合固定。平片型无背衬和牵引线。
该产品是可降解吻合口加固产品，其采用的生产工艺实现了去除动物组织免疫原性的同时，保留质天然细胞外基的结构和生物活性；其结构设计使产品能配套连接各种型号吻合器并提高手术安全性。该产品配合吻合器用于吻合部位的加固，适用于远端胃切除术、近端胃切除术、袖状胃切除术、胃肠吻合术，能够降低胃肠切除手术术后发生吻合口漏、出血等相关并发症，为患者带来受益。
药品监督管理部门将加强该产品上市后监管，保护患者用械安全。
信息来源：CCFDIE平台