abstract

Background: Mesire™ BRS is an innovative sinus scaffold system designed for use as a temporary implant to ensure the maintenance of patency of the Ostia of the sinuses and to provide localized administration of corticosteroids following FESS procedures.

Objectives: To conduct the biological evaluation of Mesire™ BRS in accordance with ISO 10993 standards.

Methods: A comprehensive biological assessment was performed, including in vitro assessment procedures like cytotoxicity in L-929 mouse fibroblasts. Other methods include in vivo assessment procedures such as skin sensitization in guinea pigs (Maximization Test), intracutaneous irritation in rabbits, acute systemic toxicity in mice, and 28 days sub-chronic toxicity in Sprague Dawley rats. Other procedures include the Genotoxicity test and the Pyrogenicity test, which are used to determine whether the material is capable of causing genetic toxicity and fever. Extraction of the samples was done by using polar and non-polar solvents.

Results: Mesire™ BRS had no cytotoxicity (grade 0 reactivity). Neither dermal sensitization nor intracutaneous irritation was observed from the reaction of the animals. There were no adverse effects, deaths, or changes in body weight, hematology, clinical chemistry, and histopathology in acute and sub-chronic systemic toxicity tests. In addition, the device was not Genotoxic and pyrogenic.

Conclusion: From the results obtained, it is proven that Mesire™ BRS is biocompatible and safe for its intended purpose.