江苏省2款第三类创新医疗器械获批上市

Group 1 - Jiangsu Changyida Medical Technology Co., Ltd. and Morningstar (Nantong) Medical Device Co., Ltd. have received approval from the National Medical Products Administration for their innovative Class III medical devices, namely the "Intracranial Aneurysm Assisting Embolization Stent" and the "Pulmonary Artery Thrombectomy Stent System" respectively [1][2] - In 2023, a total of 9 innovative Class III medical devices have been approved for market entry in Jiangsu Province [1] - The "Intracranial Aneurysm Assisting Embolization Stent" features a self-expanding elastic structure with adjustable length and flared ends, aimed at reducing vascular damage and enhancing vascular adhesion [1] Group 2 - The "Pulmonary Artery Thrombectomy Stent System" is designed for mechanical thrombectomy via the femoral vein, utilizing a large-caliber thrombus suction catheter to quickly restore blood flow [2] - This device offers a short preoperative preparation time, high efficiency in thrombus removal during the procedure, and rapid postoperative recovery [2] - The stent system includes various models with a gradient design for the mesh disk, which is intended to be more compatible with target blood vessels and reduce the risk of vascular damage [2] Group 3 - The Jiangsu Provincial Drug Administration is focusing on core technology breakthroughs and addressing "bottleneck" technologies to promote innovative medical device development [3] - The administration aims to enhance the transformation of clinical research results into practical applications, fostering collaboration between medical and industrial sectors [3] - Efforts are being made to reform the review and approval system, optimize the industrial ecosystem, and increase the international competitiveness of high-end medical devices in Jiangsu Province [3]