Lifetech Scientific Corporation (HKG: 1302), a biopharmaceutical company based in China, has announced the completion of the one-year follow-up of its Phase II clinical study for the IBS absorbable drug-eluting coronary stent system. The results were initially published at the EuroPCR 2024.
The prospective, multi-center, single-blinded, random-controlled Phase II study, which began in March 2022, completed enrollment of 518 subjects across 36 centers in China over nine months. Participants were randomly assigned to the experimental group, receiving the IBS coronary stent, and the control group, receiving the Xience everolimus eluting coronary stent, at a 1:1 ratio. The one-year clinical follow-up demonstrated no significant difference in the target lesion failure rate (TLF) between the two groups (2.3% vs 2.7%, P=0.78). Additionally, there was no significant difference in the incidence of cardiogenic death (0 vs 1.2%, P=0.20) and target vessel related myocardial infarction (0.4% vs 1.2%, P=0.37). Importantly, no instrument related thrombotic events were observed in either group. The study suggests that the IBS coronary stent is comparable to mainstream drug eluting metal stents in terms of safety and efficacy.
The IBS coronary stent features a matrix made of a high-strength, high-plasticity, and high-purity nitrided iron tube, marking it as the world’s first fully biodegradable iron-based absorbable coronary stent. Its innovative material research and unique technological paths enable the product to maintain the benefits of permanent metal coronary stents, such as complete specifications, superior physical properties, and good biocompatibility, while offering the additional advantage of full biodegradability, effectively avoiding potential long-term prognosis issues associated with permanent metal stents.- Flcube.com
