沛嘉醫療-B(09996.HK):HighLife經房間隔二尖瓣置換系統科研臨牀試驗於中國完成首例患者植入
格隆匯12月28日丨沛嘉醫療-B(09996.HK)發佈公吿,沛嘉的HighLife經房間隔二尖瓣置換(“TSMVR”)系統科研臨牀試驗已於中國招募首名患者。2021年12月22日,中國四川大學華西醫院的陳茂教授及其團隊成功完成首例植入。公司的外部顧問加拿大蒙特利爾麥吉爾大學心臟病介入專家Nicolo Piazza醫生通過遠程視頻在線指導手術過程。這是亞洲完成的首例TSMVR系統植入。
該系統基於HighLife SAS開發及轉讓的技術,並由公司於中國製造。採用獨特的“Valve-in-Ring”理念,使該系統能夠自同軸和自適應。適用二尖瓣解剖結構的雙元件設計可適用於絕大多數患者。該系統設計可降低瓣周漏風險並有效減小輸送器尺寸。
2020年12月18日,公司與法國醫療器械公司HighLife SAS訂立許可協議,據此,HighLife SAS已就大中華地區的若干專有經導管二尖瓣置換術(“TMVR”)產品向公司授出獨家許可。技術轉讓已於2021年第三季度完成,並已建立中國本土製造設施。是次首次成功植入案例標誌着公司在中國TMVR領域取得重要進展。
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