On February 23, 2023, the IBS Angel™™ Iron Bioresorbable Scaffold System independently developed by Biotyx Medical (Shenzhen) Co., Ltd. obtained the EU CE MDR certification , becoming the world's first Iron-based Bioresorbable Scaffold System to obtain CE certification. This innovative product is used for minimally invasive surgical treatment of congenital heart disease.
Technological innovation benefits children
Cyanotic congenital heart disease is a cardiopulmonary disease that seriously threatens the life and health of children. If not intervened in time, the child will soon face a life-threatening situation. Currently, palliative treatment is carried out clinically through drugs and surgery (BT shunt). After the child's body grows to a certain extent, surgical heart repair is performed. Compared with traditional surgery, arterial catheter stenting has the advantages of fewer side effects, higher effectiveness, shorter operation cycle, relatively less trauma to patients, and simpler repair surgery. It is the only life-saving opportunity for children who cannot tolerate surgery. However, the stents currently used in clinical practice are all permanent stents off-label-use. During secondary heart correction surgery, it takes time to remove the stent covered by the endothelium, which will damage the child's pulmonary artery and aorta.
IBS Angel™ Iron Bioresorbable Scaffold System is compatible with a minimum of 4F sheath (inner diameter of about 1.35 mm), and is particularly suitable for the small blood vessels of newborns and infants, and does not need to be removed during secondary surgical repair. After implantation of IBS Angel™, some children have good right heart development, and the arterial ductus automatically closes as the stent degrades, so there is no need for cardiac surgical repair . This is equivalent to a minimally invasive stent procedure replacing two surgical operations!
The IBS Angel™Iron Bioresorbable Scaffold System was successfully used to open the ductus arteriosus. The immediate follow-up results after the operation showed that the stent had a good morphology and structure, and the blood flow in the ductus arteriosus was smooth.
The IBS Angel™Iron Bioresorbable Scaffold System has obtained the EU CE MDR certification, which not only provides a new, safer and more effective minimally invasive surgical treatment option for children with congenital heart disease, but also further confirms the feasibility of Biotyx Medical Iron Bioresorbable Scaffold System design concept and the safety of its iron-based bioresorbable scaffold series products.
