After three years of clinical trials, the "Anticoagulant Phenyl-Fluorosilicone Composite Artificial Blood Vessel," jointly developed by Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine and a leading domestic material enterprise, has officially passed the innovative medical device special approval by the National Medical Products Administration (NMPA). This artificial vessel uses unique phenyl-fluorosilicone rubber (P-FVMQ) as the base material and simulates the human vascular endothelial cell environment through surface grafting technology. It successfully solves the thrombus problem that easily forms in small-diameter artificial blood vessels, achieving a patency rate of 96%, reaching an international leading level. Traditional artificial blood vessels mostly use expanded polytetrafluoroethylene (ePTFE) or polyester materials, but the thrombosis rate is extremely high in vessels with diameters smaller than 6mm. The new phenyl-fluorosilicone material utilizes the hydrophobicity of phenyl groups and the low surface energy characteristics of fluorosilicone chains to greatly reduce platelet adhesion and activation. Furthermore, the material possesses excellent compliance, with an elastic modulus highly matching that of real human blood vessels, avoiding intimal hyperplasia caused by "vascular mismatch." The project leader stated that the advent of this material will save the lives of countless patients with cardiovascular diseases and plans to launch it in the second half of 2026 at only 60% of the price of imported counterparts.
IOTA FLSR3400 addition-type liquid fluorosilicone rubber