JENSCARE-B (09877.HK): LuX-Valve Plus Completes First Implantations in FDA US Pivotal Trial

NewTimeSpace · 2026/07/16 13:09 · By Zeyu Wu

NewTimeSpace News: JENSCARE-B (09877.HK) announced that LuX-Valve Plus, its self-developed transcatheter tricuspid valve replacement system, has recently completed the first subject implantations in the FDA-approved US pivotal registration trial, marking a breakthrough progress in its US clinical programme. The trial will conduct head-to-head randomised control against Edwards Lifesciences’ EVOQUE system.

NewTimeSpace News: JENSCARE-B (09877.HK) issued a voluntary announcement on 16 July 2026. LuX-Valve Plus, the Company’s independently developed transcatheter tricuspid valve replacement system, has recently completed the first subject implantations within the pivotal registration clinical trial authorised by the US FDA.

This prospective, global multi-centre trial enrolling sites across the United States, Canada and multiple European countries adopts a head-to-head randomised controlled design versus Edwards Lifesciences’ EVOQUE system, to evaluate the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation.

LuX-Valve Plus has previously obtained EU MDR CE certification. The completion of the first US clinical implantations represents another key milestone under the Company’s globalisation strategy.

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