Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres
10.12455/j.issn.1671-7104.240205
- VernacularTitle:栓塞微球的临床应用和临床评价相关思考
- Author:
Jing LIU
1
;
Jiaying GUO
Author Information
1. 国家药品监督管理局医疗器械技术审评检查长三角分中心,上海市,201210
- Keywords:
embolization microspheres;
clinical application;
clinical evaluation
- From:
Chinese Journal of Medical Instrumentation
2024;48(6):694-698
- CountryChina
- Language:Chinese
-
Abstract:
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.
