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Omrix公司推出新型外科密封劑

【?2005-06-18 發(fā)布?】 美迪醫(yī)訊
美迪網(wǎng)領(lǐng)先的醫(yī)療器械電子商務(wù)平臺(tái)

2005年1月公布的新纖維蛋白密封劑使用指南中,在標(biāo)準(zhǔn)手術(shù)方案效果不佳的時(shí)候,一種人體外科密封劑被批準(zhǔn)用于提高止血效果。

這種密封劑叫做Quixil,以前只在肝臟手術(shù)和大關(guān)節(jié)置換的時(shí)候使用,因?yàn)槠渥饔眯Ч玫搅俗C實(shí)。在傳統(tǒng)的纖維蛋白密封劑中,使用了來(lái)自牛的蛋白質(zhì)。 但是,Quixil是唯一的沒(méi)有動(dòng)物來(lái)源成份的密封劑。這種密封劑在融化后1分鐘之內(nèi)就可以使用,比傳統(tǒng)的纖維蛋白黏附性更強(qiáng)更柔軟,即使在低溫條件下也是如此,并能夠降低敗血癥的發(fā)生率。

這種兩種成分的密封劑包含兩種生物活性成份(BAC)--人凝結(jié)蛋白和tranexamic酸--和凝血酶。每一種成份在制造過(guò)程中都有兩種獨(dú)立的和不同的病毒激活和清除步驟,以減少非包膜病毒傳播的危險(xiǎn)。這也增加了滅活尚未被鑒別病原的幾率。

Quixil是Omrix生物制藥公司的注冊(cè)商標(biāo),在英國(guó)是由Johnson & Johnson公司推向市場(chǎng)的。
 
Extended Indications for Surgical Sealant

Following the publication of new fibrin sealant guidelines in January 2005, a human surgical sealant is now approved for use in improving hemostasis, where standard surgical techniques are insufficient.

Called Quixil, the sealant was previously only indicated for liver surgery and large-joint replacement where efficacy has been proven. In traditional fibrin sealants, bovine sourced proteins are present. Quixil, however, is the only sealant that is completely free of animal-sourced components. The sealant is ready for application in less than one minute after thawing and is more adherent and flexible than traditional fibrin sealants, even at low temperatures, potentially lowering sepsis rates.

The two-component sealant consists of a biologic active component (BAC)--human clottable protein and tranexamic acid--and thrombin. Each of the components undergoes two separate and different virus activation and removal steps during manufacturing to reduce the risk of transmission of non-enveloped viruses. This also increases the probability of inactivating unidentified pathogens.

Quixil is a registered trademark of Omrix Biopharmaceuticals, S.A. (Brussels, Belgium) and is marketed in the United Kingdom by Johnson & Johnson Wound Management (New Brunswick, NJ, USA).

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