心通醫療-B(02160.HK):國家藥監局批准Alwide®Plus心臟瓣膜球囊擴張導管的註冊申請
格隆匯8月4日丨心通醫療-B(02160.HK)宣佈,於2021年7月29日,公司獲得中國國家藥品監督管理局("國家藥監局")批准Alwide®Plus心臟瓣膜球囊擴張導管("Alwide®Plus")的註冊申請。
公司自主研發的Alwide®Plus為公司於2019年獲批上市的Alwide®心臟瓣膜球囊擴張導管的第二代升級產品,其主要特點包括(i)低順應性能夠實現更準確的球囊擴張尺寸;(ii)高爆破壓力適合嚴重鈣化的病變;(iii)快速充盈╱回抽可最大限度地減少起搏時間。與第一代產品相比,Alwide®Plus旨在改善爆破壓力。公司認為Alwide®Plus可降低在TAVI(經導管主動脈瓣植入)手術中進行瓣膜成形術的挑戰性。
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