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首頁(yè) > 美迪醫(yī)訊 > Cardinal公司生產(chǎn)的脊柱骨骼粘合劑獲得FDA批準(zhǔn) |
Cardinal公司生產(chǎn)的脊柱骨骼粘合劑獲得FDA批準(zhǔn) 【?2005-07-02 發(fā)布?】 美迪醫(yī)訊
一種新型骨骼粘合劑被設(shè)計(jì)給醫(yī)生用于固定脊椎骨折。這種粘合劑已經(jīng)獲得了美國(guó)食品藥品管理局的批準(zhǔn)。 這種粘合劑通常用于脊柱外科手術(shù)。在手術(shù)中,醫(yī)生在影象學(xué)檢查的引導(dǎo)之下,從后背向發(fā)生骨折的脊柱插入一根很長(zhǎng)的針,通過這根針注射骨骼粘合劑。骨骼內(nèi)粘合劑變硬從而填充骨折導(dǎo)致的縫隙,加強(qiáng)被破壞的脊椎,減輕患者的疼痛以及所承受的壓力。 這種新型Ava-Tex不透輻射的骨骼粘合劑是由一種叫做聚甲基丙烯酸甲酯(PMMA)的丙烯酸(類)樹脂制作而成的。這種骨骼粘合劑在混合之后,給醫(yī)生提供的注射時(shí)間較長(zhǎng),設(shè)計(jì)可以用于熒光成像掃描檢查。這種新型骨骼粘合劑是Cardinal公司的產(chǎn)品,并且獲得了CE標(biāo)志。 “醫(yī)生一直需要一種設(shè)計(jì)用于治療脊椎骨折的黏合劑,既然我們已經(jīng)獲得FDA的批準(zhǔn),我們十分高興能夠提供這種產(chǎn)品?!盋ardinal公司的副總裁、特殊手術(shù)部總經(jīng)理Tom Daulton如此評(píng)論說。Ava-Tex的注射時(shí)間得到了延長(zhǎng),這就為在手術(shù)中安全注射這種骨骼黏合劑提供了充足的時(shí)間。 Bone Cement for Vertebroplasty The cement is commonly used in vertebroplasty. In this procedure, doctors guided by imaging insert a long needle through the back into a fractured vertebra, injecting the bone cement through the needle. The cement hardens inside the bones and fills gaps created by the fracture, strengthening collapsed vertebrae and relieving pain and pressure for the patient. The new Ava-Tex radiopaque bone cement is made from an acrylic resin called polymethylmethacrylate (PMMA). The cement offers doctors an extended injection time once the cement is mixed and is designed for visibility with fluoroscoping imaging. The new bone cement is the product of Cardinal Health (McGaw Park, IL, USA) and has received the CE Mark. “Physicians have been asking for a cement designed to treat vertebral fractures, and we are very pleased to be able to offer this product, now that we have FDA clearance,” noted Tom Daulton, vice president and general manager of special procedures at Cardinal Health. Ava-Tex has an extended injection time, which gives doctors the extra time needed during the procedure to safely inject the cement. /**/本文關(guān)鍵字:
Cardinal公司,脊柱骨骼粘合劑,FDA
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