In the field of high-end medical implants, the biological safety of materials is paramount. The National Medical Products Administration (NMPA) has recently approved a new medical-grade solid fluorosilicone rubber for market. Due to its extremely low volatile organic compound (VOC) content and excellent anticoagulant properties, it has been approved for use in medical devices intended for long-term implantation in the human body. This material was jointly developed by a biological materials research institute and corporate partners. The R&D team employed a specialized devolatilization process to completely remove small molecule cyclic siloxanes remaining from the fluorosilicone raw gum synthesis process, reducing its biological toxicity to zero. Additionally, to improve the material's surface hydrophilicity and reduce tissue friction, trace amounts of hydrophilically modified phenyl silicone oil were introduced into the formula. Preclinical experiments demonstrated that artificial blood vessels and drainage tubes manufactured using this solid fluorosilicone rubber are less prone to thrombosis after implantation and elicit only mild tissue rejection. This achievement fills the gap in the domestic field of high-end implantable fluorosilicone rubber and reduces the reliance of related medical devices on imported materials.
IOTA FLSR3435 room temperature curing liquid fluorosilicone rubber