Minocha Dr. Pramodkumar
The Biopist™ is a thermally activated endoscopic device that allows for simultaneous tissue sample and electrocoagulation. It allows for controlled biopsy collection while cauterizing the tissue to prevent bleeding and is introduced using an endoscope's operating channel. The device is intended for tissue coagulation and histological sample in the bronchial and gastrointestinal tracts. A crucial component of preclinical safety examine is establishing the suitability of medical devices for interaction with biological systems prior to clinical usage, a process known as biocompatibility assessment. The aim of this study was to evaluate the biocompatibility of the Biopist™ by assessing it’s in vitro cytotoxicity, in vivo skin sensitization and in vivo acute systemic toxicity. Each study was done in accordance with both the ISO 10993 standards and the OECD GLP Guidelines. The L929 cell line was used for in vitro cytotoxicity testing, according to ISO 10993-5. There were no undesirable effects on cell morphology or viability based on the cell studies performed. The Maximum Sensitivity Test (as defined in ISO 10993-10) for sensitivity to skin was performed on a group of guinea pigs. All guinea pigs exhibited no evidence of edema, erythema, or delayed hypersensitivity to the test device. The evaluation of acute systemic toxicity involved the assessment on the Swiss albino mice and consisted of the administration of polar and non-polar extracts made in compliance with ISO 10993-11 and also ISO 10993-12. No gross pathology, aberrant clinical symptoms, death, or morbidity were noted during observation period. Based on the research, it was determined that the BiopistTM fulfilled ISO 10993's biological safety requirements. The findings shown that the device had no cytotoxic, sensitizing, or acute systemic toxic effects for the particular endpoints assessed. Keyword: Biocompatibility, Cytotoxicity, Skin sensitization, Acute systemic toxicity, Biopist™, and Preclinical evaluation