Jenscare Scientific Co., Ltd. reported that its proprietary transvenous tricuspid valve replacement system, LuX-Valve Plus, has secured CE certification under the European Union Medical Device Regulation (EU MDR). The approval positions LuX-Valve Plus as only the second transcatheter orthotopic tricuspid valve replacement system cleared for use worldwide, marking a pivotal step in the company’s internationalisation agenda.
The LuX-Valve Plus is designed for transvenous access, aiming to lessen cardiac tissue damage. Key differentiators include a radial-force-independent septal anchoring mechanism intended to reduce post-procedure pacemaker implantation risk, a self-adjusting fabric skirt to limit paravalvular leakage, and a multi-directional steerable delivery system to enhance deployment precision. With seven valve sizes ranging from 40 mm to 70 mm, the platform targets a broad spectrum of tricuspid regurgitation cases, including patients with complex cardiac anatomies.
Regulatory traction for the LuX-Valve series spans multiple regions: inclusion in Europe’s Expert Panel Scientific Advice Pilot, designation as a U.S. FDA Breakthrough Device, entry into the FDA Total Product Life Cycle Advisory Program, and acceptance into China’s NMPA Special Review Procedure for Innovative Medical Devices. Clinical trials have been executed or are ongoing across China, Europe, and North America, with data showcased at leading international conferences. Findings to date indicate durable reductions in tricuspid regurgitation grade, improved cardiac function, enhanced quality of life, and a low adverse-event profile.
More than 1,000 patients across dozens of countries on five continents have already received implants from the LuX-Valve product family, providing extensive real-world experience. Jenscare is now accelerating commercial rollout of LuX-Valve Plus in Europe and other key markets as part of its broader global strategy.
The company reiterates that successful market adoption remains subject to various factors, and investors are urged to exercise caution when dealing in Jenscare’s shares.