佰仁医疗:ePTFE心包膜产品获批注册

Group 1 - The core point of the article is that Baijun Medical (688198.SH) has received approval from the National Medical Products Administration for its ePTFE product, which is used for the repair or reconstruction of the pericardium during cardiac surgeries [1] - The ePTFE membrane is 0.1mm thick and serves to protect the heart surface, particularly the coronary vessels, during surgical procedures [1] - The approval of this product will end the reliance on imported ePTFE pericardial membranes in the domestic market, which has been dominated by foreign companies for a long time [1] Group 2 - The pericardium is a thin membrane that envelops the heart, and surgical damage to it can lead to serious complications, especially in pediatric patients with complex congenital heart disease [1] - The need for ePTFE membranes in cardiac surgeries is critical, as they are routinely used to repair or reconstruct damaged pericardium to protect the heart [1] - The introduction of this product is expected to significantly impact the market by providing a domestic alternative to previously imported solutions [1]