Biocompatibility assessment of experimental prototypes of russian endovascular embolization coils made of stainless steel with polymer fibers

Endovascular embolization coils are a key tool for minimally invasive vessel occlusion; however, their widespread use in Russian practice is limited by high cost and dependence on imported supplies. The development of Russian analogues requires a comprehensive assessment of the biocompatibility of designs that combine a metal frame with polymer fibers.

Aim. To evaluate the biocompatibility of experimental prototypes of embolization coils made of stainless steel with polymer fibers (silk, poly(glycolide-co-lactide), polypropylene, polyethylene terephthalate, polyvinyl chloride with barium sulfate).

Materials and Methods. Coil samples were fabricated by mechanical winding of stainless steel wire followed by manual fixation of polymer fibers in the inter-coil spaces. Hemolytic activity was assessed by the degree of hemolysis of human red blood cells upon contact with sample extracts. Cytotoxicity of the experimental coil samples with fibers was evaluated using human fibroblasts of the FEC-16-2 line by direct (co-culture) and indirect (cultivation in material extracts) methods.

Results. All studied samples met standard biocompatibility criteria: the hemolysis level did not exceed acceptable values (less than 2 %), and no cytotoxic effect was detected. The lowest hemolysis values were recorded for coils with silk fibers (0.005 ± 0.004 %). Samples with poly(glycolide-co-lactide) showed a somewhat higher hemolysis level (1.184 ± 0.212 %), which may be attributed to hydrolytic degradation of the polymer with a local decrease in pH.

Conclusion. Silk, polypropylene, polyethylene terephthalate, and radiopaque fibers based on polyvinyl chloride with barium sulfate are promising materials for the development of Russian embolization coils, offering a combination of hemocompatibility and functionality. The use of poly(glycolide-co-lactide) requires additional evaluation of long-term safety. The obtained results justify further preclinical studies, including the assessment of thrombogenicity and stability of fiber fixation under simulated blood flow conditions.

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