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Aneurysm morphology matters: Fusiform vs. saccular

机译:动脉瘤形态很重要:梭形与囊状

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摘要

Approved indications for commercially available thoracic stent-graft devices are delineated with clarity in the Instructions for Use (IFU) and include all forms of true aortic aneu-rysms, both fusiform and saccular, as well as penetrating aortic ulcers (PAU). These lesions were defined as the appropriate targets for endovascular treatment in the investigational protocols anchoring the various clinical trials that tested device safety and efficacy before approval could be granted by the US Food and Drug Administration and regulatory agencies around the world.
机译:使用说明书(IFU)中清楚地标出了市售的胸腔支架植入装置的批准适应症,包括所有形式的真正的主动脉瘤,梭形和囊状以及穿透性主动脉溃疡(PAU)。这些病变在研究方案中被定义为血管内治疗的适当靶点,这些方案锚定了各种临床试验,这些试验对装置的安全性和功效进行了测试,然后才获得美国食品药品监督管理局和全球监管机构的批准。

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