先健科技(01302.HK)左心耳封堵器系統獲美國FDA批准研究者發起的臨牀應用
2020年12月24日，先健科技(01302.HK)自主研發的LAmbre™左心耳封堵器系統獲美國食品藥品監督管理局(“FDA”)批准開展由美國當地專業醫療機構研究者發起的臨牀應用，旨在評估LAmbre™左心耳封堵器系統對具有不規則形態的心耳及\或大尺寸心耳的非瓣膜性房顫患者進行手術封堵的安全性和有效性。其手術用器械均由先健科技有償提供，將為LAmbre™左心耳封堵器系統在美國的市場準入提供支持。
LAmbre™左心耳封堵器系統由先健科技公司歷經十餘年自主研發。該產品通過經皮微創介入手術對患者左心耳進行封堵，避免血栓從左心耳中脱落後導致中風，其在產品設計和技術上均具行業先進性，擁有嚴密的全球專利佈局，並採用與國際接軌的質量標準嚴控產品品質。LAmbre™左心耳封堵器系統以“雙盤設計”、“便於操作”、“植入釋放穩定”、“型號規格齊全”、“能夠適用於各種左心耳解剖結構”、“無需深入左心耳內進行釋放”、“配適最小輸送鞘”、“併發症更少”等獨特優勢受到了業界高度認可，其已在中國、歐洲等各大中心得到廣泛應用，並已順利進入東南亞、拉美、中東非等核心市場。
本次LAmbre™左心耳封堵器系統經美國FDA批准由當地研究者牽頭開展臨牀應用，標誌着先健科技在國際化發展上邁出了更大一步，體現了北美核心市場臨牀專家對該創新產品的卓越性能和技術優勢的充分認可，將進一步為LAmbre™左心耳封堵器系統的安全性和有效性提供數據支持，併為北美具有特殊心耳形態的非瓣膜性房顫患者提供一種全新的、安全有效的中風防治方案。
從1999年成立至今，先健科技已成功築建連接其創新產品與全球市場的重要橋樑，現已在包括美國在內的6個國家設有子公司和辦事處，銷售網絡覆蓋全球100多個國家和地區，並將繼續拓展和持續深入，通過前瞻性的國際化戰略佈局，不斷深化其於全球市場的參與度，為各國醫生和患者提供安全有效的創新介入醫療器械解決方案。
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