Xianjian Technology (01302) issued an announcement that IBS independently developed by the group can absorb...
Zhitong Finance App News, Xianjian Technology (01302) issued an announcement. IBS independently developed by the Groupabsorbable drug-eluting coronary stent system (IBS)(Coronary stent) has successfully completed a one-year follow-up of the Phase II clinical study, and was first announced globally on May 14, 2024 by Director Song Lei of Fuwai Hospital of the Chinese Academy of Medical Sciences on behalf of Academician Gao Runlin and all researchers at the 2024 European Interventional Cardiology Conference (EuroPCR 2024).
IBSThe coronary stenting 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 (Xienceeverolimus 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. Available data provides preliminary evidence of IBSCoronary stents are not inferior to mainstream drug-eluting metal stents in the current market, showing ideal safety and efficacy.
As stated by the company, IBSThe 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.
IBS this timeThe one-year follow-up results of the coronary stent phase II clinical study were announced, further strengthening the evidence-based medical evidence for this innovative product and laying a solid foundation for the global development of this product and other core products on the company's iron-based bioabsorbable materials platform. Currently, IBSThe coronary stent has successfully submitted an application for CE registration and is expected to succeed IBS AngelTMAfter the iron-based absorbable scaffold system, it is the second iron-based absorbable scaffold product successfully commercialized in the EU. As subsequent clinical trials progress steadily, it is expected that more evidence-based medical evidence will further confirm the safety and efficacy of this product. The company believes that after a successful listing, IBSCoronary stents will bring unprecedented treatment to patients with coronary heart disease around the world.