医学
动脉导管
穿孔
食品药品监督管理局
临床试验
心脏病
经皮
内科学
心脏病学
外科
药理学
冶金
材料科学
冲孔
标识
DOI:10.3760/cma.j.issn.2095-428x.2020.01.002
摘要
Percutaneous intervention with occluder has become the preferred radical therapy for most of common congenital heart diseases, such as atrial septal defect (ASD), ventricular septal defect and patent ductus arteriosus.At present, most occluders for clinical use are made of nitinol, which will permanently exist in human body after implantation, and lead to the risk of severe complications such as chronic inflammation, cardiac perforation and high-grade atrioventricular block.Biodegradable occluder will be gradually replaced by body tissues after implantation.Investigators are exploring to develop biodegradable occluder with different biodegradable materials.In particular, a completely biodegradable atrial septum occlusion system (Absnow™) developed by the team of professor Zhang Zhiwei has been approved for clinical trial by China Food and Drug Administration (CFDA) in 2018, which is the first completely biodegradable atrial septal defect occluder entered the clinical trial phase in the world.The results of human trial test demonstrated the initial safety and effectiveness of this occluder.However, multi-center clinical trials are needed for evaluation and verification.Currently, selecting suitable materials for developing new biodegradable occluders, and the effectiveness and safety of occluders are the focuses and development trend of studies on biodegradable occluders in the treatment of congenital heart diseases.
Key words:
Congenital heart disease; Biodegradable/Bioabsorbable; Occluder
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