Core Viewpoint - The company, Xianjian Technology (01302.HK), has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices. This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, marking a significant advancement in the field [1]. Group 1 - The CSTM stent system is the world's first integrated arch branch reconstruction solution that does not require brain ischemia, addressing a critical need in vascular surgery and endovascular intervention [1]. - This product is the 17th to enter the special review procedure by the National Medical Products Administration, indicating the company's strong pipeline of innovative medical devices [1]. - The aortic arch region is known for its complex anatomy and unique hemodynamics, making it one of the most challenging areas in vascular surgery [1]. Group 2 - The CSTM stent system was developed in collaboration with Professor Shu Chang from the National Center for Cardiovascular Diseases and Fuwai Hospital, showcasing the company's commitment to partnerships in advancing medical technology [1]. - The system employs a unique groove and integrated structure, fundamentally addressing multiple technical challenges associated with traditional endovascular techniques in arch branch reconstruction [1]. - This innovation provides a systematic, minimally invasive, and safer solution for complex arch lesions, representing a significant leap forward in treatment options [1].
先健科技(01302.HK):Concave Supra 一体式弓部三分支重建系统进入创新医疗器械特别审查程序