Balance Medical: Innovative product "Transcatheter Valve-in-Valve System" approved for registration
Balance Medical announced that its innovative product Renato® transcatheter valve-in-valve system has received registration approval from the National Medical Products Administration. This product is specifically designed for patients with damaged implanted biological valves who face high-risk surgery, featuring a unique structure and characteristics that allow for secure anchoring at the inflow end of the valve, marking the beginning of the era of re-intervention treatment for artificial biological valves
According to the Zhitong Finance APP, Balance Medical (688198.SH) announced that recently, after review by the National Medical Products Administration, the world's first transcatheter valve-in-valve product designed specifically for patients with implanted artificial biological valves that are damaged and life-threatening, and facing high surgical risks, the Renato® transcatheter valve-in-valve product has been approved for registration. Unlike all previously implanted or transcatheter-intervened artificial biological valves, this product is designed and developed based on the anatomical structure of artificial biological valves, with a structure and characteristics that allow for stable anchoring at the valve seat position of the inflow end of the artificial biological valve. Referring to the fact that all implanted artificial biological valves have a regular circular shape at the inflow end and various inner diameter sizes of artificial biological valves, the registered product is designed with a specification for every 2mm diameter difference to achieve more precise valve-in-valve anchoring. The registration and industrialization of this product marks the beginning of the era of re-intervention treatment for artificial biological valves
