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沛嘉醫療-B(09996.HK)發佈HighLife SAS經導管二尖瓣置換系統的可行性研究部分臨牀數據
格隆匯 04-19 06:14

格隆匯4月19日丨沛嘉醫療-B(09996.HK)發佈公吿,HighLife SAS經導管二尖瓣置換術(“TMVR”)系統(公司經許可利用經房間隔路徑治療二尖瓣返流患者的TMVR產品)的兩項可行性研究的部分臨牀數據,已在於2021年4月15日至17日召開的第三屆中國結構性心臟病大會上發佈。

這兩項可行性研究的前18位連續接受治療的患者數據報道了技術成功性,安全性事件和血流動力學表現。前18位患者,16位患者成功植入瓣膜,並進入隨訪階段。這18位患者概無轉外科手術或再次干預。在成功植入瓣膜的16位患者中,有1位患者身故,其餘15位患者至今仍然在生,未發生致殘性卒中、心肌梗死、左心室流出道梗阻、器械移位、血栓或斷裂,亦無轉外科手術病例。這15位患者的血液動力學表現從3+/4+級二尖瓣返流改善為無╱少量╱1+級。

公司股東及潛在投資者可參考Ruediger Lange教授在第三屆中國結構性心臟病大會上的演講,以獲取更多有關該產品及臨牀研究的資訊。

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