LIFETECH SCI (01302) has announced that it received an official written notice from the National Medical Products Administration (NMPA) on September 9, 2026, confirming that the LantvalTM aortic valve replacement system, jointly developed by its subsidiary Shenzhen Jianxin Medical Technology Co., Ltd. (Jianxin Medical) and the National Center for Cardiovascular Diseases' Fuwai Hospital of Chinese Academy of Medical Sciences, has been admitted into the NMPA's innovative medical device special review process.
The product, designed for the surgical treatment of patients with aortic stenosis or stenosis combined with regurgitation, is the world's first sutureless aortic valve replacement product featuring a fully pre-mounted dry valve design. It marks the eighteenth product from the company to enter the NMPA's special review program for innovative devices.
Aortic stenosis (AS) stands as one of the most common valvular heart diseases. With China's aging population steadily increasing, the number of patients with aortic valve disease continues to grow. Patients with severe aortic stenosis, in particular, often face poor prognoses and low survival rates without timely and effective treatment.
The product integrates the strengths of traditional surgical aortic valve replacement (SAVR)—including the removal of native calcified leaflets, reliable hemodynamic performance, and long-term durability—with the self-expanding, sutureless anchoring design principles of transcatheter aortic valve replacement (TAVR). For leaflet processing, the project team applied its proprietary innovative dry membrane treatment technology, aimed at improving the storage and usage methods of bioprosthetic valves while further enhancing the long-term durability of the valve leaflets.
The fully pre-mounted, ready-to-use design supports rapid implantation through minimally invasive small incisions, reducing suture procedures, significantly shortening operation time, and lowering procedural complexity. It offers a new surgical solution for aortic valve disease that balances minimally invasive benefits with superior performance.
The product completed its first-in-human (FIM) clinical trial in 2025. Study data showed that valve implantation time was significantly shorter than conventional surgical valve replacement procedures. All subjects completed primary endpoint follow-up, with favorable postoperative recovery and quality of life outcomes. The FIM results preliminarily validated the engineering and clinical feasibility of the first integrated "dry valve + fully pre-mounted + sutureless" surgical valve replacement product, demonstrating its clinical value in simplifying surgical procedures, shortening valve implantation time, reducing paravalvular leak risk, improving hemodynamics, and enhancing valve durability.
The group owns the independent intellectual property rights for this product. The pre-market registration clinical study is about to commence. As subsequent clinical trials progress steadily, a growing body of high-quality evidence-based medical data will further confirm the product's safety and efficacy.