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)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