The Jenscare-B (ASX: 09877) group has announced a significant milestone in its internationalization strategy. Its self-developed Transvenous Tricuspid Valve Replacement System, LuX-Valve Plus, has recently obtained EU MDR CE certification.
The LuX-Valve Plus is the world's second approved transvenous in-situ tricuspid valve replacement product. It is designed to minimize cardiac tissue trauma through a transvenous approach. Its design features an interventricular septal anchoring mechanism that does not rely on radial force, which aids in post-operative right heart remodeling and effectively reduces the risk of pacemaker implantation. An adaptive leak-proof sealing skirt helps minimize paravalvular leakage post-surgery. A multi-dimensional adjustable delivery system facilitates precise positioning during valve deployment. The system offers seven size models ranging from 40mm to 70mm, aiming to address a wide spectrum of unmet clinical needs for tricuspid regurgitation.
Series Product Recognition
The LuX-Valve series has been selected for the European Expert Panel Scientific Advice Pilot, received FDA Breakthrough Device designation, been chosen for the FDA Total Product Life Cycle Advisory Program, and entered the NMPA's special review process for innovative medical devices.
Clinical Validation and Global Experience
The LuX-Valve Plus has undergone and completed a series of clinical trials in major markets including China, Europe, and North America. Clinical data has been prominently presented at multiple top-tier international academic conferences, garnering high recognition from the global market and expert clinicians worldwide. Follow-up results have demonstrated the product's sustained and excellent safety and efficacy profile. Patients have shown significant improvement in tricuspid regurgitation grade, sustained enhancement of cardiac function, a substantial increase in quality of life, while maintaining a low incidence of adverse events.
The LuX-Valve series has been clinically implanted in over a thousand patients across dozens of countries and regions spanning five continents. This has accumulated substantial application experience and addressed a significant clinical treatment gap for patients with tricuspid regurgitation, particularly those with complex anatomical structures.
Commercialization Efforts
The company is actively and rapidly advancing the commercialization process for LuX-Valve Plus in Europe and globally, in pursuit of its long-term international strategic objectives.
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