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心通醫療(02160.HK)獲批VITAFLOW LIBERTYTM註冊申請
阿思達克 08-31 20:19
心通醫療(02160.HK)公布,於2021年8月30日,獲得國家藥監局批准第二代經導管主動脈瓣植入(TAVI)產品,即VitaFlow LibertyTM經導管主動脈瓣植入系統(VitaFlow LibertyTM)的註冊申請。 VitaFlow LibertyTM由PAV(人工主動脈瓣)、電動輸送系統及若干手術配套產品組成。與其第一代TAVI產品相比,關鍵升級在於輸送系統的獨家創新結構,保證其在實現PAV可回收功能的同時,提供優異的通過性能,從而有助於通過嚴苛的解剖結構。 和VitaFlow LibertyTM一起獲證的還有公司的第一代尖端預塑型超硬導絲Angelguide,尖端預塑型超硬導絲具有高導絲導軌支撐和平滑過渡的特點,以減少血管損傷及提升釋放精准性。此外,VitaFlow LibertyTM創新性地引入內聯導管鞘設計,以擴大血管適配範圍。
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