IBS®可吸收药物洗脱冠脉支架系统
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先健科技(01302)公布IBS®可吸收药物洗脱冠脉支架系统II期临床研究及III期临床研究两年随访结果
智通财经网· 2025-10-29 11:40
Core Viewpoint - The company has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS absorbable drug-eluting coronary stent system, with results to be presented at the TCT 2025 conference in the U.S. [1][2] Group 1: Clinical Study Results - The two-year follow-up results of the Phase II clinical study showed that the late lumen loss in the lesion segment was 0.28±0.52mm in the experimental group and 0.23±0.43mm in the control group, achieving non-inferiority for the primary endpoint [1] - No stent thrombosis events occurred in the experimental group, while one event was reported in the control group [1] - The two-year clinical follow-up results of the Phase III clinical study indicated a target lesion failure (TLF) rate of 5.5%, with only five stent thrombosis cases reported, resulting in a thrombosis event rate of 0.5% [1] Group 2: Product Innovation and Market Potential - The IBS coronary stent is the world's first fully biodegradable iron-based absorbable coronary stent, made from high-strength and high-plasticity high-purity nitrided iron tubing, featuring a thin wall and strong support [2] - The innovative material research and unique technical approach allow the product to retain the advantages of permanent metal stents while also being fully absorbable, effectively avoiding long-term prognosis issues associated with permanent metal stents [2] - The publication of the two-year follow-up results for the Phase II and Phase III clinical studies enhances the evidence base for this innovative product, with data submitted for regulatory approval in China and the EU, potentially providing a safe and effective treatment for coronary heart disease patients globally [2]
先健科技(01302.HK):IBS可吸收药物洗脱冠脉支架系统公布II期临床研究及III期临床研究两年随访结果
Ge Long Hui A P P· 2025-10-29 11:25
Core Viewpoint - The company, Xianjian Technology (01302.HK), has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS® absorbable drug-eluting coronary stent system, with results to be presented at the TCT 2025 conference [1] Group 1 - The IBS® coronary stent has completed two-year follow-ups for both Phase II and Phase III clinical studies [1] - The results will be presented by Professor Song Lei from the Chinese Academy of Medical Sciences at the TCT 2025 conference held on October 26-27, 2025 [1] - The studies include major endpoint imaging follow-up results from the Phase II clinical study and clinical endpoint follow-up results from the Phase III clinical study [1]
先健科技(01302) - 自愿公告 - IBS可吸收药物洗脱冠脉支架系统公布II期临床研究及III...
2025-10-29 11:05
先健科技公司 (在開曼群島註冊成立的有限公司) 香港交易及結算所有限公司與香港聯合交易所有限公司對本公佈的內容概不負責,對其準確性或完 整性亦不發表任何聲明,並明確表示概不就因本公佈全部或任何部份內容而產生或因依賴該等內容 而引致的任何損失承擔任何責任。 LifeTech Scientific Corporation (股份代號:1302) 自願公告 本公司董事(「董事」)會(「董事會」)欣然宣佈,本集團自主研發的IBS®可吸收藥物洗 脫冠脈支架系統(「IBS®冠脈支架」或「本產品」)已順利完成II期臨床研究(「II期臨床 研究」)和III期臨床研究(「III期臨床研究」)兩年隨訪,並於美國當地時間二零二五 年十月二十六至二十七日,由中國醫學科學院阜外醫院宋雷教授代表高潤霖院士和 全體研究者於二零二五年經導管心血管治療年會(「TCT 2025」)向全球公佈IBS®冠 脈支架II期臨床研究的兩年主要終點影像隨訪結果和III期臨床研究的兩年臨床終點 隨訪結果。 IBS®冠脈支架II期臨床研究是一項前瞻性、多中心、單盲、隨機對照臨床研究, 主要研究終點為冠脈支架植入術後兩年病變節段內晚期管腔丟失。II期臨床研究於 ...