沛嘉醫療-B(09996.HK):國家藥監局批准Tethys AS® 血栓抽吸導管註冊申請
格隆匯5月22日丨沛嘉醫療-B(09996.HK)發佈公吿,2022年5月20日,集團收到國家藥品監督管理局對Tethys AS®血栓抽吸導管註冊申請的批准,使其成為集團第12個獲國家藥監局批准的神經介入產品。
Tethys AS®血栓抽吸導管是由加奇生物有限公司(公司全資附屬公司)所開發的一款大內腔、高到位、具有抽吸適應證特點的急性缺血性卒中產品。Tethys AS®血栓抽吸導管的0.071英寸大內腔可以提高血栓抽吸能力,縮短手術時間。產品擁有更長的遠端柔軟段,能夠順應迂曲血管,提高遠端血管到位性。其優化的過渡段設計提高了跟蹤性,易於推送至目標血管。產品採用全程“線圈+編織”複合結構,抗負壓能力強,擁有良好的管腔保持能力。Tethys AS®血栓抽吸導管提供2款內徑、4種有效長度,共14個型號。術者可根據操作習慣和患者情況進行選擇,以滿足不同的臨牀使用需求。
根據多項高質量的臨牀研究表明,抽吸取栓已成為急性缺血性卒中患者血管內介入治療的一線治療方法。至此,針對急性缺血性卒中患者,加奇生物已能提供包括支架取栓術式和抽吸取栓術式在內的多種治療方案,產品系列涵蓋 Tethys AS®血栓抽吸導管、Syphonet®取栓支架、Tethys®中間導引導管、Presgo®微導絲、Presgo®微導管和即將獲批的Fluxcap®球囊導引導管等多款器械,以滿足機械取栓術式的臨牀需求。加奇生物將繼續豐富缺血性卒中領域的產品佈局,持續助力國內卒中中心的建設,推動急性缺血性卒中患者的救治工作。
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