CorFlow Therapeutics宣布MOCA-II IDE關鍵性試驗獲得FDA核准，旨在驗證新型心臟病發作治療技術
這項名為MOCA-II的IDE關鍵性試驗旨在前瞻性驗證專有CorFlow CoFl系統在原發性經皮冠狀動脈介入治療(PCI)過程中診斷微血管阻塞(MVO)存在與否的準確性。主要終點是將CoFI診斷結果與心臟磁振造影(MRI)掃描的診斷參考標準進行對比。該試驗已獲准在美國和歐洲的知名研究機構招募200多名ST段上升型心肌梗塞(STEMI)病患。
在2024年成功完成MOCA-I首次人體試驗後，MOCA-II研究成為將這一獨特技術推向全球介入心臟病學家的關鍵一步，協助其快速診斷心臟病發作病患的MVO問題。這進而可望為大量MVO病患帶來新的治療方法和護理路徑——目前這類病患的臨床不良結局發生率較高。CorFlow技術不僅旨在診斷MVO，還能做為局部藥物遞送系統，用於輸送診斷劑和治療劑，相關研究正在獨立進行中。
美國政府疾病控制與預防中心的資料顯示，美國每30秒就有一人突發心臟病，每年報告病例約80萬例。歐洲的發病率和患病率也處於類似高位。超過一半的STEMI心臟病發作病患被證實存在MVO，且既往研究顯示，MVO的存在是導致不良事件的主要因素。目前，在歐美地區，尚無獲准可在急性冠狀動脈介入治療期間診斷MVO的技術，也沒有專門針對MVO的獲准治療器材。心臟病發作及相關心臟疾病仍是全球導致死亡和身心障礙的主要原因之一。
CorFlow執行長Paul Mead表示：「介入心臟病學和心臟病發作護理領域的突破可追溯至100多年前，這是醫療護理進步的重大成功案例之一，但該領域的先驅和傑出人士都認同，這項工作尚未完成。大多數急性STEMI倖存者存在MVO問題，而目前這些病患的預後差得驚人。我們旨在揭露這一問題，並證明人們能夠為此採取行動。這一里程碑讓我們向兌現改善這些病患護理的承諾又邁進了一步——我們深知在這方面我們能做得更好。」
MOCA-II試驗由心臟病發作護理領域的世界知名專家主導，分別是美國俄亥俄州辛辛那提市基督醫院的Timothy Henry博士，以及瑞士盧加諾市提契諾心臟中心研究所的Marco Valgimigli教授。兩人在心血管研究領域共發表了超過1000篇經同儕審查的論文。
Tim Henry博士表示：「身為一名從事STEMI病患治療和研究數十年的介入心臟病學家，我對這項關鍵性試驗的啟動感到振奮不已——相關技術可望對病患的預後產生重大影響。我堅信，在原發性PCI過程中，在護理現場高度確信哪些病患存在MVO，能立即改變我們對病患的治療方式。」Valgimigli教授補充說道：「我是MOCA-I首次人體試驗的重要參與者，如今看到第二代技術可用於關鍵性試驗，我感到非常激動，並期待能進一步協助對MVO的即時科學理解。儘管醫學界對於如何治療這類病患存在不同觀點，但毫無疑問，準確診斷是我們需要邁出的第一步。我樂觀地認為，CorFlow技術獲准供同行介入心臟病學家日常使用後，將有助於推動該領域的發展。」
關於CorFlow Therapeutics：公司總部位於瑞士巴爾，在義大利和美國設有子公司。CorFlow由國際創投公司共同投資，最近一輪融資是2024年9月宣布的B輪融資。CorFlow立志成為診斷和治療解決方案領域的領導者，以恢復存在關鍵需求的人體任何部位的健康微血管血流。在瑞士創新署(Innosuisse)的資助下，CorFlow與伯恩大學、蘇黎世聯邦理工學院和蘇黎世大學醫院的科學家密切合作，持續探索這項獨特專利技術的應用場景。
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