歸創醫療ZYLOX® Penguin靜至髂靜脈支架系統獲NMPA批准上市
1月22日，歸創通橋(2190.HK，以下簡稱"公司")宣佈，旗下歸創醫療自主研發的ZYLOX® Penguin靜至髂靜脈支架系統獲國家藥品監督管理局(NMPA)批准上市。這標誌着歸創醫療佈局外周靜脈疾病介入治療整體解決方案再次取得里程碑式的進展，並進一步鞏固其在外周血管介入領域的市場地位和影響力。
ZYLOX® Penguin靜至髂靜脈支架系統是由歸創醫療與國內知名專家合作開發的創新醫工結合產品。該產品擁有8項發明專利，專為髂靜脈壓迫所致的下肢、盆腔靜脈迴流障礙性疾病而設計。ZYLOX® Penguin靜至髂靜脈支架系統採用斜口設計、錐形漸變、集成結構三大設計，旨在降低血栓形成的風險，同時確保順應血管的自然變徑。ZYLOX® Penguin靜至髂靜脈支架系統擁有卓越的貼壁性和漸變的慢性擴張力，近心端閉環結構提供強大的支撐力，遠心端開環結構則提供優異的順應性。
ZYLOX® Penguin靜至髂靜脈支架系統上市前臨牀註冊試驗由重慶醫科大學附屬第一醫院的趙渝教授擔任組長單位，歷時10個月共納入全國14家頂級臨牀中心的161例手術，術後12個月靶血管的通暢率達到100%。這一出色的臨牀試驗效果，充分證明了該產品的安全性和有效性。
髂靜脈壓迫綜合徵(Iliac Vein Compression Syndrome, IVCS)，是一種由髂靜脈受到壓迫導致的血液循環障礙。主要症狀包括腿部疼痛、腫脹，有時伴有深靜脈血栓形成。髂靜脈壓迫綜合徵的治療方案主要包括藥物治療、外科治療及血管介入治療。目前，利用髂靜脈支架的介入治療已經成為治療IVCS的主要方法。
根據弗若斯特沙利文預計，2030年中國IVCS的潛在發病數達到百萬級；同時預計髂靜脈支架介入手術數量2019年至2030年的年複合增長率接近50%。隨着歸創醫療ZYLOX® Penguin靜至髂靜脈支架系統的上市，相信將為中國患者帶來更高質量及可及性的國產創新髂靜脈壓迫治療方案。
截至目前，歸創通橋已有36款產品獲NMPA批准上市，8款產品取得歐盟CE認證，1款產品在巴西上市。歸創通橋已逐漸成為產品組合最全面、最具有競爭力的國產血管介入醫療器械平台公司之一。未來，公司將繼續堅持開發具有顯著臨牀價值的差異化創新產品，服務全球患者。
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