LIFETECH SCI (01302): The aortic membrane stent system has received official registration approval from the China National Medical Products Administration.

LIFETECH SCI (01302) announced that on February 8, 2025, the professor Shu Chang from Fuwai Hospital of the Chinese Academy of Medical Sciences led the development of the aortic membrane stent system in collaboration with the group, which has been officially registered and approved by the Chinese National Medical Products Administration. This product is the first aortic membrane stent system specifically approved for chimney technology by the National Medical Products Administration, providing a simple, safe, effective, and anatomically broad treatment option for patients with lesions involving the aortic arch. The product consists of the AnkuraTM Pro aortic main body membrane stent system and the LonguetteTM aortic branch membrane stent system. The AnkuraTM Pro uses an ePTFE membrane and offers 0-10 taper options to meet different clinical needs. The LonguetteTM skirted stent utilizes a double-layer design with an outer skirt that can effectively fill the gap between the branch stent and the aortic stent after release, expected to prevent and reduce leaks and complications. Three-year follow-up results show a leakage rate of only 3.36%, much lower than traditional chimney techniques (10.7% - 16.4%). The inner high-density nitinol alloy skeleton provides strong radial support in the proximal reinforcement segment to prevent compression by the aortic stent, ensuring long-term patency of the branch vessel. The one-year postoperative follow-up patency rate of branch vessels is 97.87%, higher than the traditional chimney technique (93%). The product is easy to operate, safe, and efficient, with an immediate technical success rate of 99.33% and a one-year postoperative false lumen treatment success rate of 95.77%. The product has independent intellectual property rights and multiple international patents, and is expected to provide a complete, safe, and effective endovascular repair solution for patients with lesions involving the aortic arch. This solution is completely delivered by intervention, with the advantage of causing less trauma and being simpler to operate. This product is the first approved product in the company's overall solution for aortic arch branch reconstruction. With the continuous progress of the commercialization process, the company will provide a more flexible, complete, safe, effective, and easy-to-operate overall solution for endovascular reconstruction of the aortic arch, and work with industry experts to advance the development and launch of more clinically needed medical device products, driving the development of the group in the field of medical devices, benefiting a large number of patients.