Confluent公司推出頭顱手術的密封系統

Confluent公司推出頭顱手術的密封系統
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一種新型系統設計用于在頭顱手術中輔助進行雙重修補獲得防水閉合。該套系統已經獲得美國食品藥品管理局的許可，進行批準后的臨床試驗。

DuraSeal是獲得專利保護的、合成的、可吸收的水凝膠，通過雙重注射涂藥器給藥。這套設備儲存于室溫之下，能夠在2分鐘內完成準備工作。當噴射到硬腦膜之上的時候，可以產生強大的黏附密封層，能夠在幾秒鐘之內有效地封閉縫合口。其獨特的特征是其藍色著色劑，能夠讓外科醫生方便地觀察硬腦膜上面的涂層以及厚度。

在手術之后，密封層能夠持續密封膠下面的縫合線。在數周之后，水凝膠分解成為水溶性分子，被腎臟吸收清除出體外。臨床試驗顯示：密封系統能夠在98％的患者之中產生防水密封效果，在95％患者之中第一次應用即可獲得密封效果。使用這種產品的神經外科醫生將95％的應用過程評價為“容易～非常容易。”

這項多中心臨床試驗的首席研究員、南佛羅里達大學神經外科主席Harry van Loveren指出：“迄今為止，硬腦膜的防水閉合一直是很難達到的目標。我很有信心這種產品能夠對我的頭顱手術產生深刻影響。”

DuraSeal是Confluent外科手術公司的產品，該公司是一家私人醫療設備公司，致力于安全的使用簡便的原位聚合生物物質的研發，允許在疾病部位形成定制移植物。

Sealant System for Cranial Surgery

A new system is designed as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure. The system has been cleared by the U.S. Food and Drug Administration (FDA) with a condition to conduct a post-approval study.

DuraSeal is a patented, synthetic, absorbable hydrogel that is delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes.

When sprayed onto the dura, it produces a strong adherent sealing layer that effectively seals the suture line within seconds. A unique feature is the blue colorant that gives the surgeon excellent visualization of coverage and thickness of the material upon application to the dura.

Postoperatively, the sealant continues to seal the suture line as healing progresses under the gel. After several weeks, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys. Clinical studies show that the sealant can achieve watertight closure in 98% of cases, with immediate sealing obtained on the first application in 95% of cases. Neurosurgeons using the product rated 95% of applications as “easy” to “very easy.”

“Watertight closure of the dura has to date been an elusive goal,” noted Harry van Loveren, M.D., chairman of the department of neurosurgery, University of South Florida (St. Petersburg, USA) and principal investigator in a multi-center study. “I’m confident it will have a profound effect on my cranial procedures.”

DuraSeal is the product of Confluent Surgical (Waltham, MA, USA), a private medical device company pioneering the development of in-situ polymerized biomaterials that are safe, simple to use, and allow the formation of customized implants at the disease site.


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