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Cardinal公司生產的脊柱骨骼粘合劑獲得FDA批準


 

一種新型骨骼粘合劑被設計給醫生用于固定脊椎骨折。這種粘合劑已經獲得了美國食品藥品管理局的批準。

這種粘合劑通常用于脊柱外科手術。在手術中,醫生在影象學檢查的引導之下,從后背向發生骨折的脊柱插入一根很長的針,通過這根針注射骨骼粘合劑。骨骼內粘合劑變硬從而填充骨折導致的縫隙,加強被破壞的脊椎,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,給醫生提供的注射時間較長,設計可以用于熒光成像掃描檢查。這種新型骨骼粘合劑是Cardinal公司的產品,并且獲得了CE標志。

“醫生一直需要一種設計用于治療脊椎骨折的黏合劑,既然我們已經獲得FDA的批準,我們十分高興能夠提供這種產品。”Cardinal公司的副總裁、特殊手術部總經理Tom Daulton如此評論說。Ava-Tex的注射時間得到了延長,這就為在手術中安全注射這種骨骼黏合劑提供了充足的時間。

Bone Cement for Vertebroplasty

A new bone cement is designed for use by doctors to fix fractures of the spine. The cement has been cleared by the U.S. Food and Drug Administration (FDA).

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.

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