LIFETECH SCI announced the two-year follow-up results of the Phase II and Phase III clinical studies of the IBS® absorbable drug-eluting coronary stent system
LIFETECH SCI announced the two-year follow-up results of its IBS® absorbable drug-eluting coronary stent system from the Phase II and III clinical studies. The study showed that the late lumen loss in the Phase II trial group was 0.28mm, compared to 0.23mm in the control group, achieving non-inferiority for the primary endpoint. In the Phase III study, the two-year target lesion failure (TLF) rate post-implantation was 5.5%, with only 5 cases of stent thrombosis occurring, resulting in a thrombosis event rate of 0.5%. This stent is the world's first fully biodegradable iron-based absorbable coronary stent, featuring good biocompatibility and ease of operation
According to the Zhitong Finance APP, LIFETECH SCI (01302) announced that the group's independently developed IBS® absorbable drug-eluting coronary stent system has successfully completed two years of follow-up for both Phase II and Phase III clinical studies. On October 26-27, 2025, local time in the United States, Professor Song Lei from Fuwai Hospital of the Chinese Academy of Medical Sciences, representing Academician Gao Runlin and all researchers, will present the two-year primary endpoint imaging follow-up results of the IBS® coronary stent Phase II clinical study and the two-year clinical endpoint follow-up results of the Phase III clinical study at the Transcatheter Cardiovascular Therapeutics Annual Meeting (TCT 2025).
The two-year follow-up results of the Phase II clinical study of the IBS® coronary stent showed that the late lumen loss in the lesion segment (experimental group: 0.28±0.52mm, control group: 0.23±0.43mm) achieved non-inferiority for the primary endpoint. No stent thrombosis events occurred in the experimental group, while one stent thrombosis event occurred in the control group.
The two-year clinical follow-up results of the Phase III clinical study of the IBS® coronary stent showed that the target lesion failure (TLF) rate was 5.5% two years after the implantation of the IBS® coronary stent. Only five stent thrombosis events occurred within two years, with an event rate of only 0.5%. Among these, four occurred within one month, and three were clearly due to non-device-related reasons.
To the company's knowledge, the IBS® coronary stent is the world's first fully biodegradable iron-based absorbable coronary stent. Its matrix is made from high-purity nitrogen-doped iron tubes with high strength and high plasticity, resulting in a thin-walled stent with strong support. Innovative material research and a unique technical pathway allow this product to retain the advantages of permanent metal coronary stents, such as a complete range of specifications, superior physical properties, good biocompatibility, and ease of operation, while also possessing the characteristic of complete absorbability, effectively avoiding a series of long-term prognostic issues that may arise from the implantation of permanent metal stents.
The announcement of the two-year follow-up results of the Phase II and Phase III clinical studies of the IBS® coronary stent further strengthens the evidence-based medical evidence for this innovative product. Currently, the clinical study follow-up data of the IBS® coronary stent has been submitted to the National Medical Products Administration and EU CE registration approval, and it is expected to bring an unprecedented, safe, and effective treatment method for global coronary heart disease patients in the near future, laying a solid foundation for the global development of other core products on the company's iron-based biodegradable materials platform
