N. Shchotkina, Y. Palamarchuk, I. Skorokhod, L. Dolinchuk, A. Sokol, V. Motronenko, A. Besarab, M. Frohme, M. Herzog
{"title":"心脏生物植入物技术调控特点","authors":"N. Shchotkina, Y. Palamarchuk, I. Skorokhod, L. Dolinchuk, A. Sokol, V. Motronenko, A. Besarab, M. Frohme, M. Herzog","doi":"10.22494/cot.v11i1.147","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":36461,"journal":{"name":"Cell and Organ Transplantology","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Features of technological regulation for cardiac bioimplants\",\"authors\":\"N. Shchotkina, Y. Palamarchuk, I. Skorokhod, L. Dolinchuk, A. Sokol, V. Motronenko, A. Besarab, M. Frohme, M. Herzog\",\"doi\":\"10.22494/cot.v11i1.147\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":36461,\"journal\":{\"name\":\"Cell and Organ Transplantology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cell and Organ Transplantology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22494/cot.v11i1.147\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cell and Organ Transplantology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22494/cot.v11i1.147","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
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.