China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received CE MDR certification in the European Union (EU) for its in-house developed IBS Angel iron-based absorbable stent system. This marks the world’s first commercialization of such a stent system in the EU, targeting the minimally invasive surgical treatment of congenital heart disease, specifically cyanotic congenital heart disease.
Significance of the Certification
Cyanotic congenital heart disease is a serious heart and lung system disease that poses a significant threat to children’s life and health, often leading to death without timely intervention. Current palliative treatments primarily involve surgical procedures like the B-T shunt, with more extensive surgical heart repairs conducted once the child reaches a certain age. The introduction of the IBS Angel stent system addresses these challenges by offering a degradable solution.
Innovative Features of IBS Angel
The IBS Angel stent’s degradability is a fundamental innovation in the field. Constructed from a high-purity nitrided iron pipe, the stent boasts high strength and plasticity, allowing for a thin support wall and strong support force. It is compatible with a 4F sheath (with an inner diameter of about 1.35mm), making it particularly suitable for the small blood vessels of newborns and infants. A key advantage is that it does not need to be removed during later surgical repair procedures. Clinical trials have demonstrated that some children experience improved right heart development post-implantation, and the arterial duct closes automatically as the stent degrades, potentially eliminating the need for subsequent cardiac surgical repair.
