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先健科技LAnavi™分段控彎導引系統中國首發 — 引領左心耳封堵術進入新時代
格隆匯 04-21 07:58

先健科技公司(01302.HK)宣佈,其自主研發的LAnavi™分段控彎導引系統已於2021年3月通過國家藥品監督管理局(NMPA)註冊批准,並於2021年4月17日在第七屆中國心電生理和起搏青年論壇召開期間成功進行產品的上市發佈。

該產品是全球首個商業化的左心耳封堵分段雙可調彎導引系統,將為先健科技自主研發的LAmbre™左心耳封堵器提供個性化輸送方案,全面引領左心耳封堵術進入新時代。通過實現術中精準導航,同軸封堵,從而便利臨牀醫生的手術操作,有助於進一步優化學習曲線,讓LAmbre™左心耳封堵更簡單、更安全可控。

LAnaviTM,總有一個角度更“貼心”

在行左心耳封堵術時,需對房間隔進行穿刺,導引系統中的鞘管與左心耳開口的“同軸性”(即“軸向”)是保證手術成功率以及降低併發症的關鍵。目前已商業化的左心耳封堵導引系統均無法實現在術中調整彎度,而患者的心臟解剖結構千差萬別,固定的鞘管彎度無法滿足所有手術的“軸向”需求,臨牀中不乏因軸向不佳而無法到達理想的封堵器釋放位置,從而導致封堵失敗的案例。

基於對醫生臨牀需求的深入洞察,先健科技LAnavi™分段控彎導引系統應運而生。該產品獨特的分段雙可調彎設計突破了心臟解剖結構的限制,降低了對房間隔穿刺的要求,可實現在左心房內多角度多平面自由調節,滿足了左心耳封堵手術中的軸向需求,在保證手術封堵效果與安全性的同時,為臨牀醫生節省手術時間。同時,該產品能夠適應各種左心耳解剖結構和心耳開口位置,尤其為複雜心耳形態的封堵提供了極大便利。

(圖:先健科技LAnavi™分段控彎導引系統)

創新搭檔 開啟左心耳封堵新紀元

2021年4月17日,於第七屆中國心電生理和起搏青年論壇召開期間,先健科技LAnavi™分段控彎導引系統上市發佈會在武漢盛大開幕。中國左心耳封堵領域頂級專家匯聚一堂,共同見證先健科技又一重大創新成果的重磅發佈。

河北醫科大學第二醫院謝瑞芹教授、中南大學湘雅二醫院劉啟明教授、武漢大學人民醫院黃鶴教授、復旦大學附屬中山醫院周達新教授、武漢大學人民醫院黃從新教授、山東大學齊魯醫院鍾敬泉教授、先健科技研發副總裁李安寧先生及先健科技營銷副總裁方宇先生上圖從左至右)共同啟動先健科技LAnavi™分段控彎導引系統上市發佈儀式。

中國房顫中心聯盟主席、武漢大學人民醫院黃從新教授表示:“我們欣喜地見證先健科技LAnavi™分段控彎導引系統的問世。它是繼LAmbre™左心耳封堵器系統之後,先健科技為我們左心耳封堵領域帶來的又一款創新良器。同時,它也是我國國產醫療器械振興之路上的又一個里程碑,將惠及更多房顫卒中患者,助力健康中國。”

先健科技作為全球首個,也是全球唯一同時擁有CE和NMPA上市許可的中國品牌的左心耳封堵器的研發及生產企業,一直致力於左心耳封堵術的推廣和普及,並積極應用多種先進技術和創新智慧讓左心耳封堵更簡單、更安全可控。

先健科技LAnavi™分段控彎導引系統的問世,將幫助臨牀醫生解決手術軸向難題,從而讓手術的成功率和患者的安全性得到更充分的保障。LAnavi™與LAmbre™的創新結合,將進一步推動LAmbre™左心耳封堵器的臨牀使用,促進中國左心耳封堵事業的發展,並讓廣大房顫卒中患者從中受益。

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