LIFETECH SCI (01302.HK): IBS coronary stent wins EU CE MDR, world first iron-based scaffold

On October 30, LifeTech Scientific (01302.HK) said its IBS coronary stent won EU CE MDR certification, the world's first iron-based scaffold.

NewTimeSpace News: According to the HKEX on October 30, LifeTech Scientific Corporation ("LifeTech", 01302.HK) announced that on October 29, 2026, the IBS absorbable drug-eluting coronary stent system independently developed by its subsidiary Yuanxin Technology (Shenzhen) Co., Ltd. obtained EU CE MDR certification, becoming the world's first iron-based coronary stent system to receive marketing approval.

According to the announcement, the IBS coronary stent is the world's first fully degradable iron-based absorbable coronary stent, with an iron-nitrogen alloy matrix offering strength, plasticity and elasticity comparable to cobalt-chromium alloys, with a thin strut (55-65μm) and stronger radial support. Through precise control of the degradation cycle, the iron scaffold basically does not degrade in the first three months, disintegrates in six months and is fully absorbed in three years.

The company said the Phase III clinical study enrolled 1,060 patients, with a one-year target lesion failure (TLF) rate of 2.7%, meeting the non-inferiority target, and a two-year cardiac death rate of 0.1% (versus 1.2% in the control group). After CE approval, the product will begin a large randomized controlled post-marketing study in Europe, and it has obtained clear cooperation intention from distributors in 60 overseas countries or regions.

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