Jenscare Secures LuX‑Valve Approval for Transjugular Tricuspid Replacement in Greater Bay Area

Jenscare Secures LuX‑Valve Approval for Transjugular Tricuspid Replacement in Greater Bay Area

Jenscare Scientific Co., Ltd (HKG: 9877) announced that its LuX‑Valve Plus transjugular tricuspid valve replacement system has received official inclusion in the Hong Kong‑Macau Medicine and Equipment Connect Medical Device Catalog. The approval authorises commercial clinical use in designated mainland Greater Bay Area hospitals, marking a pivotal step for the company’s transcatheter portfolio.

Regulatory Milestone

  • Catalog Inclusion – LuX‑Valve Plus is now listed in the HK‑Macau Medical Device Catalog, the prerequisite for commercial deployment in mainland China.
  • Geographic Scope – Approved for use in Greater Bay Area institutions, aligning with China’s “Made In China” initiative for advanced medical devices.
  • Compliance – Meets stringent safety, performance, and quality standards set by the Hong Kong‑Macau regulatory framework.

Product Innovation

  • Design – Features a globally innovative valve with ventricular‑septum anchoring and a self‑adaptive anti‑leak ring, eliminating paravalvular regurgitation.
  • Delivery – Fully transjugular approach, avoiding sternotomy and reducing procedural risk.
  • Sizing – Seven available diameters (40 mm‑70 mm) accommodate diverse anatomical profiles.
  • Safety Profile – Worldwide implantations demonstrate excellent safety and durability.

Clinical Impact

  • Target Population – Patients with severe tricuspid regurgitation and prohibitive surgical risk.
  • Efficacy – Follow‑up studies show significant symptom relief, reduced hospital admissions, and improved survival.
  • Global Adoption – Already implanted in multiple centers worldwide, with positive outcomes reported in peer‑reviewed journals.

Market Outlook

  • Competitive Advantage – First‑in‑class transjugular tricuspid solution in China, filling a critical therapeutic void.
  • Revenue Potential – Expected to capture a sizeable share of the growing transcatheter valve market in the Greater Bay Area.
  • Strategic Partnerships – Opportunity for collaboration with local hospitals and device distributors.-Fineline Info & Tech