NEWS

Lifetech's Absorbable Stent Completes First Implantation in the US

Release time:

2022-04-01 15:37

Recently, Lifetech announced that its iron-based absorbable stent system IBS Angel has completed first implantation in the United States. The product was approved by the FDA in May 2021.
It is understood that IBS Angel is an absorbable stent specially designed and developed for children's pulmonary blood vessels. It is used to improve the lumen diameter of pulmonary blood vessels in children who need stent treatment. It is a fully degradable pulmonary vascular stent with iron-based as the main material. The degradability of IBS Angel can fundamentally solve a series of problems of existing treatment methods. (1) Without thoracotomy, this product implants the stent into the patient's pulmonary artery through the catheter to maintain the human pulmonary circulation. (2) Its mechanical properties and clinical manipulation properties are comparable to those of cobalt-chromium alloy permanent stents, and the diameter of the stent can cover the entire diameter range of pulmonary vessels. (3) The stent is made of high-strength and high-plasticity high-purity nitrided iron tube. The stent has a thin wall and strong supporting force, which can easily enter the small blood vessels of newborns and infants. (4) After implantation, it can maintain effective support for blood vessels during the period of vascular remodeling, prevent the elastic retraction of blood vessels, and then the stent begins to gradually degrade and absorb, which will release the radial restraint on blood vessels without affecting the normal growth of blood vessels.


It is reported that the company has started the research and development of iron-based absorbable stents since 2006, and launched clinical trials in Malaysia and Europe in 2018. It has shown good safety and efficacy in clinical practice. The data shows that IBS Angel has a 100% success rate, and the youngest patient is a 12-day-old newborn. It can palliatively maintain the blood flow of the right heart and lungs in children with complex congenital heart disease, promote the development of the right heart and lungs, prolong the time window for the second heart surgery for children, and reduce the difficulty and death of the second surgery. Rate. In some of these cases, after the IBS Angel stent was implanted, the child was exempted from a second surgical procedure. In addition, the histopathological analysis of the IBS Angel stent taken out in the second orthopedic surgery showed that the stent completes endothelialization within 90 days in the human body, and the degradation of the stent can reach 60%-70% in about 1 year. Inflammation is mild.
This time, the patient who received the IBS Angel implant was only 7 months old, had Tetralogy of Fallot and had undergone surgical revision surgery. The child developed right ventricular outflow tract obstruction not long ago, and timely surgical intervention was required. Considering the patient's medical history and age, repeat surgery would cause huge surgical trauma and extremely high surgical risk, so stent implantation was considered to be the most suitable treatment for this patient.


For young children, the normal growth of the right ventricle will be restricted after permanent stent implantation, and the potential surgical intervention in the later stage will be more difficult. The IBS Angel iron-based absorbable stent system has brought a new treatment options.