LIFETECH SCI (01302.HK): Aortic Arch Single-Branched Stent Graft System Enters NMPA Innovative Device Special Review

NewTimeSpace News: On 24 September 2026, LifeTech Scientific Corporation (stock code: 01302) announced that it received formal written notice from the National Medical Products Administration (NMPA) confirming that the SureCham aortic arch single-branched stent graft system, jointly developed with the team of Professor Shu Chang at Fuwai Hospital, Chinese Academy of Medical Sciences (National Center for Cardiovascular Diseases), has entered the NMPA's Innovative Medical Device Special Review Procedure. Indicated for the treatment of aortic dissection involving the aortic arch, it is the Company's 19th product to enter the procedure.

The announcement noted that thoracic endovascular aortic repair (TEVAR) has become the main treatment for lesions involving the aortic arch, while traditional TEVAR faces the conflict between insufficient proximal anchoring and coverage of the left subclavian artery. With an adjustable branched structure and a single transfemoral access as the core design, the product allows complete reconstruction of the main stent graft and branch through a single femoral puncture; the branch can be adjusted bidirectionally by 5 mm protruding or recessing to fit various arch types and branch angles, and the branch delivery sheath is only 8F, simplifying the procedure and reducing access-related complications.

In a multi-centre clinical study, the product has been enrolled and completed in 135 cases across 24 centres in China, showing an immediate technical success rate of 100%, a rate of freedom from major adverse events within 30 days after the procedure of 97.78%, and the shortest operation time of only 9 minutes; post-procedural CT follow-up showed patent branch arteries and good true lumen remodelling in all cases. The Company owns independent intellectual property rights of the product, which has been applied in clinical practice in Europe and parts of Asia.

The product will form the Company's total endovascular solution for aortic arch lesions together with its chimney-technique and in-situ fenestration product matrices for arch branch reconstruction and the CSTM integrated three-branched arch reconstruction system. Entry into the procedure signifies that the product's innovative design and clinical value have received authoritative recognition, and is expected to accelerate its clinical translation and commercialisation.

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