LifeTech's IBS coronary scaffold shows promising trial results

LifeTech Scientific Corporation revealed the successful completion of two-year follow-up for its Phase II and Phase III clinical studies of the IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System. The results, announced at TCT 2025, showed the Phase II study met its primary endpoint of non-inferiority for in-segment late lumen loss, with experimental group results of 0.28 ± 0.52 mm compared to the control group's 0.23 ± 0.43 mm, and no experimental stent thrombosis.

The Phase III study, which enrolled 1,060 patients, reported a Target Lesion Failure (TLF) of 5.5% two years post-implantation, with a 99% follow-up rate. Only five cases of experimental stent thrombosis occurred, with an incidence of 0.5%, and three of these were non-device related. The IBS Coronary Scaffold, the world's first iron-based bioresorbable coronary scaffold, demonstrated excellent results compared to other scaffolds and permanent metal stents, with TLF levels at an ideal range.

The data supports the scaffold's safety and effectiveness, having achieved non-inferiority to mainstream drug-eluting metal stents during the two-year follow-up. Clinical study data has been submitted to the NMPA and European Union for CE registration, anticipating global availability for coronary heart disease treatment.