[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].

Jing Liu, Jiaying Guo
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引用次数: 0

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.

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【栓塞微球的临床应用及临床评价问题】。
栓塞微球可用于实质器官高血管恶性肿瘤的栓塞。它们也可以作为手术的辅助治疗,通过术前血管内栓塞肿瘤来减少围手术期出血。本研究总结了微球栓塞的临床指南和共识,并介绍了美国食品药品监督管理局(FDA)发布的微球栓塞指导文件。此外,本研究还提出了作者对栓塞微球临床评价的思考,旨在为此类产品的临床评价和技术评价提供见解。
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来源期刊
中国医疗器械杂志
中国医疗器械杂志 Medicine-Medicine (all)
CiteScore
0.40
自引率
0.00%
发文量
8086
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.
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