新招! FDA紧急授权血液净化装置应对新冠-奥咨达

新招! FDA紧急授权血液净化装置应对新冠

2020-04-14 09:57  阅读数:44 标签:

FDA官网新闻发布:

2020年4月10日,美国食品和药物管理局发布了一项血液净化系统的EUA(应急使用授权),用于治疗已确诊患有2019冠状病毒(COVID-19)的18岁或18岁以上的患者,该病人是已确诊或即将出现呼吸衰竭,被送往重症监护病房(ICU)的患者。


该授权产品通过减少细胞因子和其他炎症介质的数量起作用,即血液中控制细胞免疫反应的小分子活性蛋白,通过过滤血液并将过滤后的血液返回给病人。被移除的蛋白质通常在感染期间升高,可能与在某些COVID-19患者身上出现的“细胞因子风暴”有关,导致严重炎症,迅速进展性休克,呼吸衰竭,器官衰竭和死亡。


FDA专员斯蒂芬·M·哈恩(Stephen M。Hahn)说:“我们继续在各个部门开展工作,加快开发许多具有创新潜力的预防措施和治疗方法,通过这两项紧急促进措施,为病人紧急治疗提供便利,在我们力所能及的范围内,支持对潜在疗法的评估。随着今天血液净化设备的授权,我们正在加快为重症监护病房的病人提供治疗方案,以帮助减轻疾病的严重程度。我们的工作人员将继续对所有医疗产品进行全天候的审查,加快提供治疗,帮助抗击这一毁灭性疾病。”


Terumo BCT公司的Spectra Optia单采血液分离系统与Marker Therapeutics公司生产的Depuro D2000吸附盒配合使用,获得该项FDA的紧急使用授权。



原文译自FDA:


The U。S。 Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure。

The authorized product works by reducing the amount of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M。 Hahn, M。D。 “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease。 Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease。”

The FDA issued this emergency use authorization to Terumo BCT Inc。 and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices。


Hi,are you ready?

准备好开始了吗?
那就与我们取得联系吧

有一个医疗器械项目想和我们谈谈吗?您可以填写右边的表格,让我们了解您的项目需求,这是一个良好的开始,我们将会尽快与你取得联系。当然也欢迎您给我们写信或是打电话,让我们听到你的声音!

奥咨达 | 高端医疗器械临床注册专家

24小时免费咨询热线:

400-6768632

填写您的项目信息

填写完表单后,请点击以下任意一种沟通方式: