Lepu Medical (300003.SZ) Announces MemoSorb® Fully Bioabsorbable Occluder System Receives NMPA Approval

Lepu Medical (300003.SZ) announced that the MemoSorb® Fully Bioabsorbable Occluder System, independently developed by Shanghai Shape Memory Alloy Co., Ltd., a wholly-owned subsidiary of its structural heart disease medical device platform LEPU ScienTech Medical Technology (Shanghai) Co., Ltd. (referred to as: ScienTech Medical), has recently been officially approved for a medical device registration certificate by the National Medical Products Administration.

It is reported that congenital heart disease refers to the abnormal three-dimensional structure or functional defects of the heart or intrathoracic blood vessels caused by formation disorders or developmental abnormalities of the heart and blood vessels during embryonic development, or the failure of channels that should close automatically after birth to do so. The clinical gold standard for treating congenital heart disease is interventional occlusion, which involves delivering an occluder to the corresponding site of congenital cardiac defect through peripheral vascular puncture and catheter delivery.

The announcement stated that the fully degradable occluder system independently developed by ScienTech Medical has achieved an innovative upgrade from metal materials to fully degradable materials. After being implanted into the human body, the occluder serves as a temporary bridge, promoting self-tissue repair before gradually degrading. It eventually breaks down into carbon dioxide and water, which are excreted from the body, leaving no foreign objects behind. This avoids the risk of long-term complications associated with traditional metal occluders that remain permanently in the body, providing patients with a healthier heart.