Features of technological regulation for cardiac bioimplants

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 Genom of Enteroviruses in the Blood Serum of Patients with Acute Stroke.

Objective of the study was determination of enterovirus genom presence in the blood serum of patients with acute stroke by polymerase chain reaction (PCR). The blood serum of 72 patients with acute stroke and control group of 30 patients with another vascular disease was studied to reveal genom of enteroviruses. Detection of enterovirus RNA was performed by PCR using the reverse transcription. Viruses were isolated on HeLa and HEp-2 cell lines. The enterovirus genom detected by PCR was in 17 of 72 samples of the tested serum in the research group (23,6±5,0%). In the control group only one serum was PCR-positive for enteroviruses (3,3±3,2%). Cytopathogenic agents were isolated in HEp-2 and HeLa cell lines from 11 PCR-positive samples of blood serum from the experimental group of patients. No viruses were isolated from the remaining PCR-positive and PCR-negative sera. The presence of enteroviruses in the blood of patients with acute stroke suggests etiopathogenetical link between them. The introduction of PCR to detect enteroviral agents in patients with acute stroke can complement existing methods of diagnosis