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Bairen Medical: Innovative valved patch for complex congenital heart disease gets NMPA approval
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Bairen Medical (688198.SH) announced that its self-developed innovative product, a valved patch for complex congenital heart disease, has received approval for registration from China's National Medical Products Administration. The product is designed for surgical implantation in children under 2 years old with conditions such as pulmonary stenosis or atresia, and Tetralogy of Fallot, which require right ventricular outflow tract reconstruction. It is available in single-valve and double-valve models, intended to widen the right ventricular outflow tract and effectively prevent regurgitation, thereby protecting right heart function. The company cautioned that the actual sales performance of the product after launch is uncertain and will be influenced by market promotion and other factors, making it impossible to predict its impact on future revenue.
Source report
Shanghai, September 23 — Bairen Medical (688198.SH) announced that its independently developed innovative product, a valved patch for complex congenital heart disease, has been approved for registration by the National Medical Products Administration (NMPA).
The product is designed for surgical implantation in children under two years of age with complex congenital heart disease. It is indicated for patients requiring right ventricular outflow tract reconstruction, including those with:
- Pulmonary stenosis or atresia
- Tetralogy of Fallot
The valved patch is available in two models:
- Single-valve type
- Double-valve type
The device is intended to widen the right ventricular outflow tract while effectively preventing regurgitation, thereby protecting right heart function.
The company noted that actual sales performance following the product's market launch will be influenced by factors such as market promotion, and it is currently unable to predict the product's future impact on revenue.
Source
财联社Eastern
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Bairen Medical’s valved patch for complex congenital heart disease wins China regulatory approval