Patients with congenital heart defects and cardiovascular diseases are required new approaches to surgical intervention. The use of biological cardiac implants, which are made from the extracellular matrix, is a promising trend in modern regenerative medicine. These bioimplants can completely replace defective tissue or organs, and when manufactured with strict protocols and quality control measures, can be safe and effective for therapeutic applications. The process of manufacturing bioimplants involves various risks that need to be assessed and mitigated with ongoing monitoring and evaluation necessary to ensure the highest standards of quality. Overall, this study was successfully evaluated the requirements for introducing a new medical device into practice and created a technical file that meets all necessary documentation for certification.

The use of xenotissue for the needs of regenerative and cardiovasculare medicine is a promising area of tissue engineering. The decellularization process provides complete purification of the elastin-collagen matrix of the bovine pericardium from cells and their components. The use of high concentrations of sodium dodecyl sulfate and glutaraldehyde can lead to a damage of the extracellular matrix. Therefore, the purpose of this study was to study the microarchitectonics of the decellularized matrix using a low concentration of sodium dodecyl sulfate (0.1% solution) and avoiding glutaraldehyde. Further stabilization and fixation of the matrix was carried out using 10 mM 1- carbodiimide hydrochloride and 10 mM N-Hydroxysuccinimide. The effect of decellularization was assessed by staining the samples with hematoxylin-eosin and by scanning electron microscopy. Also the research results confirmed the absence of structural changes in the collagenelastin fibers of the matrix after sterilization dose of 10 kGy. Thus, it can be assumed that the radiation method of sterilization may be safe in use for sterilization of bioimplants.

The use of xenotissue for the needs of regenerative and cardiac medicine is a promising area of tissue engineering. The decellularization process provides complete purification of the elastin-collagen matrix of the bovine pericardium from cells and their components. The use of high concentrations of sodium dodecyl sulfate and glutaraldehyde can lead to a damage of the matrix architectonics. Therefore, the purpose of this study was to study the microarchitectonics of the decellularized matrix using a low concentration of sodium dodecyl sulfate (0.1% solution) and avoiding glutaraldehyde. Further stabilization and fixation of the matrix was carried out using 10 mM 1-Ethyl-3 (3-dimethylaminopropyl) carbodiimide hydrochloride and 10 mM N-Hydroxysuccinimide. The effect of decellularization was assessed by staining the samples with hematoxylin-eosin and by scanning electron microscopy. The research results confirmed the absence of structural changes in the collagen-elastin fibers of the matrix. Thus, the efficiency of using the proposed technology for obtaining a decellularized matrix based on the bovine pericardium was confirmed.