Core Insights - 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 TCT2025 conference [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 for the experimental group and 0.23±0.43mm for 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 events occurring, resulting in a thrombosis event rate of 0.5% [1] Group 2: Product Innovation and Regulatory Progress - 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 clinical study follow-up data for the IBS coronary stent has been submitted for approval to the National Medical Products Administration and EU CE registration, potentially providing a groundbreaking and safe treatment option for coronary heart disease patients globally [2]
先健科技公布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