JENSCARE-B(09877.HK): LuX-Valve Plus Transcatheter Tricuspid Valve Replacement System Secures EU MDR CE Certification
NewTimeSpace News: Jenscare Scientific Co., Ltd. (09877.HK) announced on 8 July that its self-developed LuX-Valve Plus transcatheter tricuspid valve replacement system has obtained EU MDR CE certification, making it the world’s second approved in-situ transcatheter tricuspid valve replacement product. Over 1,000 clinical implantations have been completed across dozens of countries and regions on five continents globally. The device has received FDA Breakthrough Device designation and entered NMPA’s Special Review Procedure for Innovative Medical Devices. The Company cautions that there is no guarantee of successful product launch and commercialisation.
NewTimeSpace News: Jenscare Scientific Co., Ltd. issued a voluntary announcement dated 8 July 2026. LuX-Valve Plus, an in-house developed transcatheter tricuspid valve replacement system, has been granted EU MDR CE certification, rendering it the second globally approved in-situ transcatheter tricuspid valve replacement device.
LuX-Valve Plus adopts an intravascular access and ventricular septal anchoring design independent of radial support force. It comes in seven sizes ranging from 40mm to 70mm, covering a broad spectrum of clinical tricuspid regurgitation cases. The device has been selected for the scientific advice pilot programme by a European clinical expert committee, obtained FDA Breakthrough Device designation, and entered NMPA’s Special Review Procedure for Innovative Medical Devices. More than 1,000 clinical implantations have been performed in dozens of countries and regions across five continents worldwide.
The Company stated that it will accelerate the commercial rollout of LuX-Valve Plus in Europe and globally to deliver its internationalisation strategy. Meanwhile, it reminds investors that there is no assurance the product can be successfully launched and commercialised in the end.
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