Xianjian Technology (01302) announced that the IBS absorbable drug-eluting coronary stent system (IBS coronary stent) independently developed by the group has successfully completed a one-year follow-up phase II clinical study, and on May 14, 2024, Director Song Lei of Fuwai Hospital of the Chinese Academy of Medical Sciences represented Academician Gao Runlin and all researchers for the first time at the 2024 European Interventional Cardiology Conference (EuroPCR 2024).
The IBS coronary stent phase II clinical study is a prospective, multicenter, single-blind, randomized controlled clinical study. The main end point of the study was advanced lumen loss within the lesion segment two years after coronary stent implantation. The Phase II clinical study was officially launched in March 2022. It took only nine months to successfully complete the enrollment of all 518 subjects at 36 domestic centers and randomly assigned 1:1 to the trial group (IBS coronary stent) and control group (Xience Everolimus drug-eluting coronary stents).
One-year clinical follow-up results showed no significant difference in target lesion failure rate (TLF) between the test group and the control group (test group: 2.3%, control group: 2.7%, P = 0.78). There was no significant difference in the incidence of cardiogenic death (test group: 0, control group: 1.2%, P = 0.20) and target vascular related heart infarction (test group: 0.4%, control group: 1.2%, P = 0.37) between the two groups of subjects, and no device-related thrombotic events occurred. The available data initially proved that IBS coronary stents are not inferior to mainstream drug-eluting metal stents in the current market, showing ideal safety and efficacy.
According to the company, the IBS coronary stent is the world's first fully degradable iron-based, absorbable coronary stent. The substrate is made of high-purity nitrided iron pipes with high strength and high plasticity, and the support is thin and the support is strong. Innovative material research and a unique technical path enable this product not only to retain the advantages of complete specifications, excellent physical properties, good biocompatibility, and easy operation, but also fully absorbable, thereby effectively avoiding a series of long-term prognostic problems that may be caused by implanting a permanent metal stent.