LIFETECH SCI(01302): The SureCham Aortic Arch Single-Branch Stent Graft System Enters the Innovative Medical Management Device Special Review Program
LIFETECH SCI (01302) announced that on September 24, 2026, the Company received official written notice from the National Medical Products Administration confirming that the SureCham Aortic Arch Single-Branch Stent Graft System (SureCham Single-Branch Stent or the "Product"), jointly developed by the Company and Professor Shu Chang's team at Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, has entered the National Medical Products Administration's Special Review Program for Innovative Medical Devices (the "Program"). The Product is indicated for the treatment of aortic dissection involving the aortic arch, and is the Company's nineteenth product to enter this Program of the National Medical Products Administration.
LIFETECH SCI(01302) announced that on September 24, 2026, the Company received an official written notice from the National Medical Products Administration, confirming that the SureCham Aortic Arch Single-Branch Stent Graft System (SureCham Single-Branch Stent or the "Product"), jointly developed by the Company and Professor Shu Chang's team at Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, has entered the National Medical Products Administration's Innovative Medical Management Device Special Review Program (the "Program"). The Product is indicated for the treatment of aortic dissection involving the aortic arch, and is the Company's nineteenth product to enter this Program of the National Medical Products Administration.
In recent years, thoracic endovascular aortic repair (TEVAR) has become the primary treatment modality for lesions involving the aortic arch. Traditional TEVAR often faces the contradiction between insufficient proximal landing zone and coverage of the left subclavian artery (LSA). Therefore, the SureCham Single-Branch Stent emerged, with its core design featuring a unique adjustable branch structure and a fully transfemoral single-access approach. Only a single puncture at the femoral artery is required to complete the integrated reconstruction of the main body and branch stent, simplifying surgical procedures and reducing the risk of access-related complications while providing a simpler and safer option for endovascular treatment of complex arch lesions.
The Group owns the independent intellectual property rights to this Product. Currently, the SureCham Single-Branch Stent has been clinically applied in certain countries and regions in Europe and Asia, and its excellent performance and clinical value have been highly recognized and widely followed by international clinical experts. This Product, together with the innovative product matrix for chimney technique-based aortic arch branch reconstruction, the innovative product matrix for in-situ fenestration-based aortic arch branch reconstruction, and the CS Integrated Three-Branch Arch Reconstruction System, will jointly constitute the Company's unique comprehensive endovascular treatment solution for aortic arch lesions. This solution helps global vascular interventional physicians more confidently, flexibly, and efficiently address the challenges of total endovascular reconstruction of aortic arch branches.
The Board believes that the Product's entry into this Program not only signifies that the innovative design and clinical value of the SureCham Single-Branch Stent have received authoritative recognition, but also marks that the Company, building on the existing single-branch technology pathway, has further explored a more simplified, more efficient, and more easily standardized aortic arch branch reconstruction solution. At the same time, it will also accelerate the clinical translation and commercialization process of this Product, bringing superior treatment options to patients with aortic dissection involving the aortic arch at an earlier date.
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