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 product in the EU. The first-in-class product is designed for minimally invasive surgical treatment of congenital heart disease, specifically cyanotic congenital heart disease.
Disease Context and Current Treatments
Cyanotic congenital heart disease is a serious condition affecting the heart and lung system, posing a significant threat to children’s health and life. Without timely intervention, it can lead to death. Current palliative treatments primarily involve surgery (B-T shunt), with surgical heart repair conducted once the child reaches a certain age.
Innovative Features of IBS Angel
The degradability of the IBS Angel fundamentally addresses the challenges associated with traditional treatments. Made from a high-purity nitrided iron pipe, the stent offers high strength and plasticity, with a thin support wall and strong support force. It is compatible with a 4F sheath (inner diameter of about 1.35mm), making it particularly suitable for small blood vessels in newborns and infants. Importantly, there is no need to remove the stent during later surgical repair procedures.
Clinical Trial Results
Clinical trials have shown that some children exhibit good right heart development after the implantation of IBS Angel. The arterial catheter automatically closes as the stent degrades, rendering subsequent cardiac surgical repair unnecessary. This innovative approach has the potential to significantly improve outcomes and reduce the need for multiple surgeries in patients with cyanotic congenital heart disease.
Significance of the Certification
The CE MDR certification underscores the innovative nature of the IBS Angel stent and its potential to revolutionize the treatment of congenital heart disease in Europe. Lifetech Scientific’s achievement highlights the company’s commitment to advancing medical technologies and improving patient care.-Fineline Info & Tech
