Recently, our independently developed LuX-Valve Plus Transcatheter Tricuspid Valve Replacement (TTVR) System received CE certification under the EU Medical Device Regulation (MDR), marking a significant milestone in the Company’s internationalization strategy.

LuX-Valve Plus is the world’s second approved transcatheter orthotopic tricuspid valve replacement system. The transvenous access approach further minimizes damage to cardiac tissue. Its radial-force independent septal anchoring design facilitates postoperative right heart remodeling and substantially mitigates the risk of pacemaker implantation. The self-adaptive fabric skirt reduces postoperative paravalvular leakage. The multi-dimensionally steerable delivery system enables precise valve deployment during procedures. Offered in seven sizes ranging from 40 mm to 70 mm, it addresses a wide range of unmet clinical needs for tricuspid regurgitation treatment.

The LuX-Valve product series have been selected for the Expert Panel Scientific Advice Pilot in Europe, granted the FDA Breakthrough Device Designation, admitted into the FDA Total Product Life Cycle Advisory Program, and entered the NMPA Special Review Procedure for Innovative Medical Devices. A series of clinical trials of LuX-Valve Plus have been conducted, with some been completed, across major markets including China, Europe and North America. Its clinical data has been prominently presented at numerous world-leading international academic conferences, winning high recognition from global markets and healthcare experts worldwide. Clinical follow-up outcomes demonstrate the device’s sustained and outstanding safety and efficacy, with marked reduction in tricuspid regurgitation grade, steady elevation in cardiac function, substantial improvement in quality of life, alongside low adverse event rate.

The LuX-Valve product series have been implanted in more than 1,000 patients across dozens of countries on five continents, generating extensive clinical experience and addressing significant unmet clinical needs for patients with tricuspid regurgitation, particularly those with complex cardiac anatomy. The Company is actively advancing the commercialization of LuX-Valve Plus in Europe and globally in support of its long-term internationalization strategy.

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