先健科技(01302.HK)IBS®冠脈支架中國確證性臨牀研究首例受試者成功入組
2022年3月10日，由先健科技(01302.HK)控股子公司元心科技(深圳)有限公司自主研發的創新產品——IBS®可吸收藥物洗脱冠脈支架系統(以下簡稱IBS®冠脈支架)在雲南省阜外心血管病醫院順利完成中國確證性臨牀研究首例受試者入組。這是先健科技在鐵基生物可吸收材料研發歷程中又一個令人欣喜的重大里程碑，進一步推動了該全球首創產品的商業化進程。
本次確證性臨牀研究以雲南省阜外心血管病醫院為組長單位，由高潤霖院士擔任主要研究者(PI)，徐波教授擔任協調研究者(CO-PI)，俞夢越教授擔任組長單位執行PI，計劃在全國40餘家中心開展臨牀驗證工作。旨在基於IBS®冠脈支架FIM臨牀(可行性臨牀研究)良好數據的基礎上，進一步評估其安全性和有效性，為其在中國註冊上市提供更為全面的臨牀依據。
IBS®冠脈支架中國確證性臨牀研究的首例受試者入組由俞夢越教授率其團隊順利開展。術中冠脈造影提示：單支血管病變，右冠中段狹窄80％，在光學相干斷層成像(OCT)指導下，成功完成靶血管的血運重建，右冠中段植入1枚支架，術中無任何併發症發生，達到預期治療效果，患者術後生命體徵平穩。
十六年潛心研發
全球首款全降解鐵基可吸收冠脈支架
IBS®冠脈支架基體由高強度和高塑性的高純滲氮鐵管加工而成，支架壁薄(支架杆總壁厚僅為70-80μm)且支撐力強。創新的材料研究和獨特的技術路徑，使IBS®冠脈支架既保留了永久金屬冠脈支架規格齊全、物理性能優越、生物相容性好、操作簡單等優點，亦兼具完全可吸收的特性。其在完成對血管的有效支撐後(即植入後3-6個月後)便開始降解，於2年左右安全進入降解尾聲，最終被人體組織所無害吸收，從而能夠有效避免植入永久支架可能帶來的一系列遠期預後問題。
此前，IBS®冠脈支架的FIM臨牀兩年期隨訪結果已初步表明其在簡單原發性冠脈病變中具有良好的中期安全有效性。 此次IBS®冠脈支架確證性臨牀研究首例患者成功入組，將為其臨牀試驗的穩步推進注入更多信心，後續將會有更多的循證醫學證據進一步證實該產品的安全性和有效性。IBS®冠脈支架在成功上市後，將為國內冠心病患者帶來前所未有的治療方式，同時也將為其進入全球市場奠定堅實基礎。
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