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Grifols Receives FDA Approval To Treat Surgical Bleeding In Pediatric Patients With Its Fibrin Sealant Solution

Grifols Receives FDA Approval To Treat Surgical Bleeding In Pediatric Patients With Its Fibrin Sealant Solution

基立福獲得FDA批准,用其纖維蛋白密封膠溶液治療小兒外科出血
Benzinga ·  10/29 20:09
  • Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis
  • Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients
  • 美國的年輕患者現在可以受益於基立福纖維蛋白密封膠(FS)及其對手術結果的積極影響,包括快速止血時間
  • 基立福外科出血管理治療產品成爲日益完善的創新治療組合的一部分,增強患者的健康和福祉

BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols ((MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding has received approval from the United States Food and Drug Administration (FDA) for pediatric patients.

西班牙巴塞羅那,2024年10月29日(環球新聞社)-- 全球醫療公司和主要血漿衍生藥品製造商基立福(MCE:GRF, MCE:GRF.P, 納斯達克:GRFS)今天宣佈,其用於控制外科手術出血的基於血漿蛋白的纖維蛋白密封劑(FS)已獲得美國食品和藥物管理局(FDA)批准用於兒童患者

The U.S. indication for children and adolescents extends the availability of FS, which is already approved for this patient segment in Europe, in addition to adults. During surgery Grifols FS promotes hemostasis and tissue sealing, resulting in reduced blood loss and potentially fewer complications.

美國適應兒童和青少年的適應症拓展了FS的適用範圍,FS已經在歐洲獲得了該患者組段的批准,而且還有成年人。手術過程中,基立福FS促進止血和組織密封,有望減少失血並減少併發症

Grifols FS biosurgery treatment is commercialized as VISTASEAL in the U.S. and Canada, and VERASEAL in Europe and elsewhere. Both brands are marketed and distributed by Johnson & Johnson MedTech, as part of a strategic collaboration between the two companies announced in 2019.

基立福FS生物外科治療在美國和加拿大以VISTASEAL的名字商業化,在歐洲和其他地方以VERASEAL的名字商業化。這兩個品牌由強生醫療公司(Johnson & Johnson MedTech)營銷和分銷,作爲兩家公司2019年宣佈的戰略合作的一部分

Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Johnson & Johnson MedTech's airless spray technology to rapidly form clots. The FS solution is now available in 18 countries.

基立福FS結合了兩種血漿蛋白,纖維蛋白原和凝血酶,並使用強生醫療公司的無氣噴霧技術迅速形成凝塊。FS溶液現在在18個國家提供

譯文內容由第三人軟體翻譯。


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