JENSCARE-B(09877): LuX-Valve Plus pivotal registration clinical trial receives FDA approval.

JENSCARE-B (09877) announced that the company's independently developed transcatheter tricuspid valve replacement system, LuX-Valve Plus, has officially received the Food and Drug Administration (FDA) approval for its pivotal clinical trial without additional conditions for investigational device exemption (IDE). This marks a significant breakthrough in the product's registration process in the United States and the company's global strategy. LuX-Valve Plus has performed well in registration clinical trials in countries such as China and Europe. Clinical data from early feasibility studies in the US further validate the device's design advantages and the safety and efficacy of its clinical application. The early feasibility study of LuX-Valve Plus has been approved by the Centers for Medicare and Medicaid Services (CMS) in the US, with the necessary devices and related costs covered by Medicare. These developments lay a solid foundation for obtaining approval for the pivotal clinical trial and subsequent market commercialization. The company will now actively move forward with enrolling patients in the pivotal clinical trial of LuX-Valve Plus, striving to obtain FDA approval for market launch as soon as possible and promote its commercialization in the US and other global regions, benefitting a wide range of tricuspid regurgitation patients worldwide.