Good News | Clarichi’s new tool for precise embolization—Zhixiu® Balloon Microcatheter has been approved for marketing!
As the New Year in the Year of the Dragon approaches, ClariCare Medical delivers another good news! On February 5, the company's self-developed blockbuster product, Zhixiu® Balloon Microcatheter, was successfully approved for marketing by the State Food and Drug Administration, adding a new tool to the full-process solution for precise embolization.
As the New Year in the Year of the Dragon approaches, ClariCare Medical delivers another good news! On February 5, the company's self-developed blockbuster product, Zhixiu® Balloon Microcatheter, was successfully approved for marketing by the State Food and Drug Administration, adding a new tool to the full-process solution for precise embolization.
The balloon microcatheter was first used in the TACE treatment of liver cancer. By filling the balloon and blocking the blood flow of the target vessel, it prevents the reflux of embolic material, thereby achieving precise embolization. This TACE treatment is called balloon blocking TACE ( Balloon-Occluded Transarterial Chemoembolization, B-TACE). B-TACE was first reported by Irie et al. Their study pointed out that the use of balloon microcatheters for embolization therapy downstream of occluded blood supply arteries can cause local changes in hemodynamics of surrounding occluded arteries and targeted HCC nodules, and prevent embolic materials from approaching. End migration and leakage. The Chinese Clinical Practice Guidelines for Transarterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma (2023 Edition) point out that B-TACE facilitates the entry of embolic substances such as lipiodol and drug-loaded microspheres into the tumor area and avoids the reflux of embolic agents. In addition, many surgeons apply arterial embolization to bronchial artery embolization, prostatic artery embolization and other diseases.
Due to equipment limitations, balloon embolization technology has only gradually emerged in China in recent years. According to public information, the distal outer diameter of the two products currently on the market in China is around 2.7F, and their clinical application is subject to many restrictions. Zhixiu® balloon microcatheter has a distal outer diameter of only 1.9F and a diameter of 1.5F~2.0F that meets the requirements for precise embolization. It is a true balloon microcatheter. This product is the first of its kind to undergo FIM research in China. The research was led by Academician Dong Jiahong and was conducted at Beijing Tsinghua Chang Gung Memorial Hospital and Peking University First Hospital. The completed research results have preliminarily proved the efficacy of the product in chemoembolization for hepatocellular carcinoma. Safety and effectiveness. In the FIM study, the measured hemodynamic changes were consistent with literature reports, providing direct evidence for the physical targeted sedimentation and aggregation of embolic materials during surgery. In addition, the Zhixiu® balloon microcatheter has a soft and compliant balloon, which can achieve safe and efficient sealing. It has double Mark points at the head end to facilitate precise positioning during surgery, and the tube body has excellent passability and smoothness. The approval for listing this time will further improve the company's full-process solution for precision embolization, provide surgeons with new tools, and further benefit more patients.
