LIFETECH SCI (01302): The LantvalTM Aortic Valve Replacement System has entered the Innovative Medical Management device special review process.

LIFETECH SCI (01302) announced that on September 9, 2026, the company received a formal written notification from the National Medical Products Administration (NMPA) confirming that its subsidiary, Shenzhen JIANXIN Medical Technology Co., Ltd. (JIANXIN Medical), in collaboration with the National Center for Cardiovascular Diseases and Fuwai Hospital of the Chinese Academy of Medical Sciences, has developed the LantvalTM Aortic Valve Replacement System, which is entering the NMPA's Special Review Process for Innovative Medical Devices. This product is suitable for surgical treatment of patients with aortic stenosis or stenosis accompanied by regurgitation, and it is the world's first fully preloaded dry valve design (sutureless) aortic valve replacement product, marking the company's eighteenth product to enter this NMPA process. Aortic stenosis (AS) is one of the most common lesions in heart valve disease. As the aging population in China continues to grow, the number of patients with aortic valve diseases is steadily increasing, particularly among those with severe aortic stenosis. Without timely and effective treatment, these patients often face poor prognoses and low survival rates. This product combines the advantages of traditional surgical aortic valve replacement (SAVR), such as the removal of native calcified leaflets, reliable hemodynamic performance, and long-term durability, with the self-expanding, sutureless anchoring design mechanism of transcatheter aortic valve replacement (TAVR). The valve leaflet processing utilizes a novel dry membrane treatment technology developed by the project team, aimed at improving the storage and use of biological valves, and further enhancing the long-term durability of the valve. The fully preloaded, ready-to-use design supports rapid implantation through minimally invasive small incisions, reduces suturing tasks, significantly shortens operation time, and lowers procedural difficulty, offering a new solution that balances minimally invasive strategies with outstanding performance for surgical treatment of aortic valve diseases. The product completed its first human clinical trial (FIM) in 2025. Research data indicated that the valve implantation time was significantly shorter than that of conventional surgical valve replacement, and all subjects completed follow-up for the primary endpoint, showing good postoperative recovery and quality of life. The FIM study results preliminarily validate the engineering and clinical feasibility of the first "dry valve + fully preloaded + sutureless" integrated surgical valve replacement product, reflecting the clinical value of this product in simplifying surgical procedures, shortening valve implantation times, reducing paravalvular leak risks, improving hemodynamics, and enhancing valve durability. The group holds independent intellectual property rights for this product. Currently, the pre-market registration clinical research for this product is about to commence. With the steady progress of subsequent clinical trials, more high-quality evidence from evidence-based medicine will further confirm the safety and efficacy of this product.