Genesis MedTech’s structural heart subsidiary, Suzhou Jiecheng, has received approval from China’s National Medical Products Administration (NMPA) for the J-Valve transfemoral transcatheter aortic valve implantation (TAVI) system (J-VALVE TF), the first transfemoral TAVI system approved in China for the treatment of aortic regurgitation (AR).
The J-VALVE TF offers an alternative to open-heart surgery by using a minimally invasive transfemoral approach, which is intended to reduce surgical trauma and procedural risk while shortening procedure time. J-Valve features a patented anchoring design which is designed to ensure secure valve placement, protecting coronary flow and reducing the risk of complications such as paravalvular leak and conduction block.
“Behind every innovation lies a patient. We are excited as this approval brings new hope to patients with severe aortic regurgitation who previously had few safe options,” said Warren Wang, chairman and chief executive officer of Genesis MedTech. “With J-Valve TF, we can now offer patients a minimally invasive solution that is safer and a faster path to recovery.”
In August 2024, Genesis MedTech announced the sale of JC Medical to Edwards Lifesciences, in a deal that included the intellectual property and commercial rights of the J-Valve system. As part of the transaction, Genesis MedTech maintained the exclusive right to develop, manufacture and commercialise the J-Valve system in Greater China.
