JENSCARE-B(09877): The first group of subjects implanted with the LuX-ValvePlus transcatheter tricuspid valve replacement system have completed the key pivotal trial approved by the FDA.

JENSCARE-B (09877) announces that its self-developed transcatheter tricuspid valve replacement system LuX-ValvePlus has successfully implanted its first subjects in the United States in a pivotal trial approved by the Food and Drug Administration (FDA) recently. This milestone represents a significant breakthrough in the US clinical registration following the EU MDR CE certification, achieving an important milestone in the company's global strategy. The pivotal trial of the transcatheter tricuspid valve replacement system LuX-Valve Plus in the United States is a prospective, global, multicenter clinical trial covering the United States, Canada, and several European countries. It will be compared head to head with Edwards Lifesciences' EVOQUE system to primarily evaluate the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation. Due to the unique design advantages and excellent clinical performance of LuX-Valve Plus, the pivotal trial in the United States has attracted active participation from multiple centers worldwide. The company will continue to accelerate the progress of its Pivotal Trial.