LifeTech Scientific Corporation (1302) has published comprehensive two-year follow-up findings from its Phase II and Phase III clinical studies evaluating the self-developed IBS® Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS® Coronary Scaffold). The results were presented at Transcatheter Cardiovascular Therapeutics 2025 (TCT 2025) on 26 and 27 October 2025 in the United States.

The Phase II study enrolled 518 subjects at 36 domestic sites, with a 1:1 random allocation to IBS® Coronary Scaffold or a control drug-eluting stent group. Two-year follow-up interpreted an in-segment late lumen loss of 0.28 ± 0.52 mm for the IBS® group versus 0.23 ± 0.43 mm for the control, meeting the non-inferiority endpoint. No experimental scaffold thrombosis was reported among patients receiving the IBS® device.

The Phase III study enrolled a total of 1,060 patients, including more than 200 from Phase II. The latest data show a two-year target lesion failure rate of 5.5% among the 1,051 patients completing clinical follow-up, with a 0.5% incidence of scaffold thrombosis. The iron-based design is highlighted as the first of its kind globally, demonstrating a combination of high radial strength and complete biodegradability. The collective data have been submitted to regulatory authorities in China and the European Union to support approvals, marking a milestone for the platform’s broader use in treating coronary heart disease.