MonoMax Suture: A New Long-Term Absorbable Monofilament Suture Made from Poly-4-Hydroxybutyrate

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