Ningbo-based structural heart disease intervention device manufacturer, Jenscare Scientific Co., Ltd (HKG: 9877), has announced that the early feasibility study (EFS) pre-submission for its LuX-Valve Plus has been accepted for review by the US FDA. This filing marks the initiation of the Investigational Device Exemption (IDE) process in the United States.
LuX-Valve Plus: A Second-Generation Transcatheter Tricuspid Valve Replacement Product
LuX Valve Plus is a second-generation transcatheter tricuspid valve replacement product that boasts multi-angle adjustable bending features. Designed to enhance ease of use during operations, this innovation aims to improve the overall success rate of the procedure. The product’s unique design addresses the complexities of tricuspid valve replacement, offering a potentially more effective treatment option for patients.
International Implantations and Ongoing Confirmatory Study in China
The LuX Valve Plus has already been successfully implanted in France and Germany in July and September 2022, respectively. Currently, the product is undergoing a confirmatory study in China, where 15 subjects have been enrolled. This study is crucial for gathering additional data to support the safety and efficacy of the LuX-Valve Plus, further solidifying its position in the market as a leading-edge treatment for tricuspid valve disease.-Fineline Info & Tech
