LIFETECH SCI (01302.HK): Aortic Valve Replacement System Enters NMPA Innovative Medical Device Special Review Procedure
NewTimeSpace News: On 10 September 2026, LifeTech Scientific Corporation (stock code: 01302) announced that the LantvalTM aortic valve replacement system, jointly developed by the company's subsidiary Shenzhen Jianxin Medical Technology Co., Ltd. and Fuwai Hospital of the National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, entered the National Medical Products Administration (NMPA) Innovative Medical Device Special Review Procedure on 9 September 2026, becoming the company's 18th product to enter the procedure.
The product is intended for the surgical treatment of patients with aortic stenosis or aortic stenosis with insufficiency, and is the world's first sutureless aortic valve replacement product featuring a fully preloaded dry-valve design. It combines the reliable haemodynamic performance and long-term durability of conventional surgical aortic valve replacement (SAVR) with the self-expanding sutureless anchoring mechanism of transcatheter aortic valve replacement (TAVR), and uses an innovative proprietary dry-membrane treatment technology for ready-to-use delivery and minimally invasive small-incision implantation. According to the announcement, the product completed its first-in-human (FIH) clinical trial in 2025, initially validating the engineering and clinical feasibility of the integrated "dry valve + fully preloaded + sutureless" surgical valve replacement design, with pre-market registration clinical studies set to commence.
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