Basic information

 Recently, after review by the State Food and Drug Administration, the outflow tract single-valve patch, an innovative product independently developed by Beijing Bairen Medical Technology Co., Ltd., was approved for registration. This product uses bovine pericardial tissue as raw material and removes cells from the tissue. The ingredients, removal of tissue immunogenicity, and series of tissue cross-linking and anti-calcification modification processes are part of the manufacturing process of the company's bovine pericardial bioprosthetic valve, based on the pathological characteristics and birth defects of the right ventricular outflow tract and pulmonary valve in children with complex congenital heart disease. The right ventricle connects the left and right pulmonary arteries with an anatomical structure of approximately 45 degrees. Combined with the clinical practice of authoritative domestic experts in complex congenital heart surgery, and with unique structural design and sewing technology, a transspan with a stent-free bovine pericardial single valve was finally developed. Valve annulus patch - outflow tract single valve patch (10-26mm), the product is suitable for patients with complex congenital heart disease who need right ventricular outflow tract repair from infants to adults. As the world's first single-valve implantable device for right ventricular outflow tract repair in complex congenital heart disease, the registration of this product fills the gap in the field of artificial transvalvular annulus widening to repair the main pulmonary artery and pulmonary valve.

Structure and composition

This product uses bovine pericardium as the main raw material and is chemically modified to make an artificial biological patch material with a single valve. The single valve is built into the patch and looks like a natural pulmonary valve structure. This product is implanted through cardiac surgery to treat patients with various right ventricular outflow tract stenosis or congenital malformations or lesions of the pulmonary artery. The product consists of chemically modified bovine pericardium tissue, PET polyester thread and PET polyester film components, and is liquid chemical sterilized.

Performance advantages

• The biggest advantage of the product is that it retains part of the autologous tissue and can grow to adapt to the age of the child after surgery;
• The product has good hemodynamic properties and can effectively ensure that blood flowing to both lungs does not reflux. Surgical implantation can both widen the right ventricular outflow tract and have a good anti-reflux effect;
• Better durability is expected for anatomical and physiological reasons;
• It has complete product models, standardized production, good quality control, high surgical success rate, easy cutting and suturing during surgery, quick postoperative recovery without anticoagulation, less prone to thrombosis, and fewer complications.

Scope of application

This product is used for the surgical correction of patients with complex congenital heart disease and right ventricular outflow tract birth defects in cardiac surgery.