LIFETECH SCI (01302) announces the two-year follow-up results of the Phase II clinical study and Phase III clinical study of the IBS absorbable drug-eluting coronary stent system.
Sinocare Technology (01302) announced that the group's independently developed IBS absorbable medication...
LIFETECH SCI (01302) announced that the self-developed IBS absorbable drug-eluting coronary stent system has successfully completed two-year follow-up of Phase II clinical study and Phase III clinical study. On October 26-27, 2025, local time in the United States, Professor Song Lei of Fuwai Hospital of the Chinese Academy of Medical Sciences, on behalf of Academician Gao Runlin and all researchers, announced the two-year main endpoint imaging follow-up results of the Phase II clinical study and the two-year clinical endpoint follow-up results of the Phase III clinical study of the IBS coronary stent at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2025) to the global audience.
The two-year follow-up results of the Phase II clinical study of the IBS coronary stent showed a late lumen loss in the diseased segment (0.280.52mm in the experimental group, 0.230.43mm in the control group), with the main endpoint being non-inferior. No thrombotic events occurred in the experimental group with the test stent, while one thrombotic 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 a target lesion failure rate of 5.5% after two years of stent implantation. Only five cases of stent thrombosis occurred within two years, with a thrombotic event rate of only 0.5%. Four cases occurred within one month, and three cases were clearly due to non-device-related reasons.
To the company's knowledge, the IBS coronary stent is the world's first fully bioabsorbable iron-based coronary stent. Its scaffold is made from high-strength and high-plasticity high-purity nitrogen-permeated iron tube, with a thin wall and strong support. The innovative material research and unique technological path have enabled this product to retain the advantages of permanent metal coronary stents in terms of complete specifications, superior physical performance, good biocompatibility, and simple operation, while also being completely absorbable. This can effectively avoid a series of long-term prognosis problems that may be caused by implanting permanent metal stents.
The announcement of the two-year follow-up results of the Phase II clinical study and Phase III clinical study of the IBS coronary stent further strengthens the evidence of this innovative product in evidence-based medicine. Currently, the follow-up data of the IBS coronary stent clinical study has been submitted for approval by the National Medical Products Administration and the European CE registration, and it is expected to bring unprecedented, safe and effective treatment for global coronary heart disease patients in the near future. This will also lay a solid foundation for the global development of other core products on the company's iron-based bioabsorbable material platform.
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