{"title":"【栓塞微球的临床应用及临床评价问题】。","authors":"Jing Liu, Jiaying Guo","doi":"10.12455/j.issn.1671-7104.240205","DOIUrl":null,"url":null,"abstract":"<p><p>Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs. They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors. This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration (FDA). Additionally, this study presents the authors' thoughts on clinical review of embolization microspheres, aiming to provide insights for the clinical evaluation and technical review of such products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"694-698"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].\",\"authors\":\"Jing Liu, Jiaying Guo\",\"doi\":\"10.12455/j.issn.1671-7104.240205\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs. They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors. This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration (FDA). Additionally, this study presents the authors' thoughts on clinical review of embolization microspheres, aiming to provide insights for the clinical evaluation and technical review of such products.</p>\",\"PeriodicalId\":52535,\"journal\":{\"name\":\"中国医疗器械杂志\",\"volume\":\"48 6\",\"pages\":\"694-698\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-11-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国医疗器械杂志\",\"FirstCategoryId\":\"1087\",\"ListUrlMain\":\"https://doi.org/10.12455/j.issn.1671-7104.240205\",\"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":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.240205","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].
Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs. They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors. This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration (FDA). Additionally, this study presents the authors' thoughts on clinical review of embolization microspheres, aiming to provide insights for the clinical evaluation and technical review of such products.
期刊介绍:
Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.