PEIJIA-B(09996): The National Medical Products Administration has accepted the registration application for the TaurusNXT "non-aldehyde cross-linked" stented aortic valve replacement system.

PEIJIA-B (09996) announced that recently, the company received a notification from the National Medical Products Administration of the People's Republic of China, confirming the acceptance of the registration application for the TaurusNXT "non-aldehyde cross-linked" dry valve transcatheter aortic valve replacement ("TAVR") system. TaurusNXT is the company's internally developed third-generation TAVR system, utilizing patented non-aldehyde biological tissue cross-linking technology to eliminate the root cause of valve calcification, which is the main cause of degeneration of artificial valves. This technology aims to improve the durability and biocompatibility of artificial aortic valves. Moreover, compared to traditional dry tissue techniques using glycerin, this system utilizes ultra-low temperature vacuum freeze-drying technology. This method helps maintain the physical integrity of valve tissue, while also allowing the artificial aortic valve to be pre-loaded onto the delivery system. The delivery system of TaurusNXT has been upgraded to have recyclable and adjustable bending characteristics, helping doctors more easily guide the artificial aortic valve to the target implantation site, thereby further enhancing the safety of the procedure. The system has been accepted into the Innovative Medical Management Device Special Approval Procedure by the National Medical Products Administration, and will be prioritized for evaluation and approval.