Table 6: Biocompatibility Testing Performed on the P4HB Suture Fiber.

Tests For Method Results Remark Cytotoxicity MEM elution Passed No evidence of cell lysis or toxicity Cytotoxicity Agarose overlay Passed No evidence of cell lysis or toxicity Irritation and sensitization Intracutaneous reactivity with saline and sesame oil extracts Passed No evidence of significant irritation Irritation and sensitization Maximization sensitization with saline and sesame oil extracts Passed No evidence of delayed dermal sensitization Systemic toxicity Acute systemic toxicity with saline and sesame oil extracts Passed No evidence of systemic toxicity Systemic toxicity Material-mediated pyrogenicity Passed Nonpyrogenic Genotoxicity, carcinogenicity, and reproductive toxicity Bacterial reverse mutation study with saline and ethanol extracts Passed Nonmutagenic Genotoxicity, carcinogenicity, and reproductive toxicity Chromosomal aberration in CHO cells Passed Not genotoxic Genotoxicity, carcinogenicity, and reproductive toxicity Mouse micronucleus study with saline and sesame oil extracts Passed Not genotoxic. No evidence of cellular toxicity. Local effects after implantation Subchronic implantation Passed Nonirritant Local effects after implantation Chronic implantation Passed Nonirritant Interaction with blood In vitro hemolysis with saline extract Passed Nonhemolytic