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佰仁医疗ePTFE心包膜产品获批注册
Bei Jing Shang Bao· 2025-12-03 10:17
Core Viewpoint - The approval of the ePTFE membrane product by the National Medical Products Administration marks a significant development for Baijun Medical, as it ends the reliance on imported ePTFE membranes in the domestic market [1] Company Summary - Baijun Medical (688198) announced the approval of its ePTFE membrane product for registration, which is a 0.1mm expanded polytetrafluoroethylene membrane [1] - The product is intended for the repair or reconstruction of the pericardium in cardiac surgery [1] Industry Summary - The current market for pericardial membranes in China has been dominated by foreign companies, leading to a long-standing dependence on imports [1] - The registration and upcoming market entry of Baijun Medical's product will disrupt this import reliance, potentially transforming the domestic market landscape for cardiac surgical materials [1]
佰仁医疗:ePTFE心包膜产品获批注册
Ge Long Hui· 2025-12-03 09:14
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]