Jenscare Showcases Positive Clinical Outcomes for LuX-Valve Plus, JensClip, and Ken-Valve at TCT 2025

Jenscare Showcases Positive Clinical Outcomes for LuX-Valve Plus, JensClip, and Ken-Valve at TCT 2025

By, Admin 30 October 2025

Jenscare Scientific Co., Ltd. (HKEX: 9877) presented new clinical data for three of its proprietary transcatheter valve systems — LuX-Valve Plus, JensClip, and Ken-Valve — at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference in the U.S. The results highlight the company’s expanding portfolio in structural heart disease treatment and its progress in developing minimally invasive solutions for high-risk patients.

6-Month Results: LuX-Valve Plus (TTVR System)

Presented by Prof. Thomas Modine, CHU de Bordeaux-Haut-Leveque, France

The TRINITY Trial, a global multicenter, single-arm study, evaluated the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation (TR) at high surgical risk.

  • Study population: 161 patients across 20 centers (primarily in Europe).
  • Device success rate: ~97%.
  • Mean procedure time: ~42 minutes (minimum 11 minutes).
  • Composite event rate at 6 months: 19.9%.
  • Cardiovascular mortality: 3.7%; stroke incidence: 0.6%.
  • No cases of myocardial infarction, vascular complications, or device-related pulmonary embolism.

Clinical benefits were consistent:

  • 94.4% of patients showed ≤ moderate TR.
  • 90.9% improved to NYHA Class I/II.
  • KCCQ scores rose by ~19 points; 6MWD increased by ~39 meters.

Prof. Modine noted that the valve’s non-radial anchoring and low imaging demands enable broad applicability for large anatomies. The U.S. FDA IDE-EFS trial of LuX-Valve Plus has also completed enrollment, showing favorable safety and efficacy.

Data also supported the transjugular approach, which demonstrated low bleeding rates (≤1.8%) and shorter procedural times, based on TRAVEL II and TRINITY findings.

1-Year Results: JensClip (TMVr System)

Presented by Prof. Vinicius Esteves, University Hospitals, Cleveland, U.S.

The JensClip trial enrolled 114 high-risk patients with degenerative mitral regurgitation (DMR) across 18 Chinese centers.

  • Device success rate: 95% at 30 days.
  • All-cause mortality: 1.8%.
  • Unplanned reintervention: 5.3%.
  • Stroke: 1.8%.

At one year, 96.3% of patients had ≤ moderate MR, and 93.5% improved to NYHA Class I/II.
KCCQ scores increased by ~20 points and 6MWD by ~82 meters.

Prof. Esteves emphasized the system’s continuous-adjustable locking and independent grasping mechanisms, enabling reliable MR reduction with procedural safety.

1-Year Results: Ken-Valve (TAVR System)

Presented by Prof. Anson Cheung, St. Paul’s Hospital, Canada

The Ken-Valve pivotal study investigated treatment outcomes for high-risk patients with aortic regurgitation (AR) or mixed valve disease.

  • Enrollment: 142 patients across 15 centers in China.
  • Device success rate: 97%; average procedure time: 8.7 minutes.
  • All-cause mortality: 5.6%; severe bleeding: 4.2%.
  • Stroke and valve migration: 2.1% each.

At one year, 94.7% showed ≤ moderate paravalvular leakage, and 96.2% improved to NYHA Class I/II.
EQ-5D scores rose by ~19 points, with stable EOA and transvalvular gradients maintained.

Prof. Cheung highlighted Ken-Valve’s integrated clamping and leak-proof ring design, providing reliable anchoring and minimizing PVL. The system’s deflectable delivery mechanism also supports precise alignment in complex anatomies.

Product Overview

  • LuX-Valve Plus: Designed for severe TR; features septal anchoring and self-adaptive leakproof ring; designated by the FDA as a Breakthrough Device and included in both the TAP and EMA Expert Panel programs. Nearly 1,000 global implantations have been performed to date.
  • JensClip: Proprietary TMVr system with self-locking clip and one-piece release design, enhancing safety and reducing procedure time.
  • Ken-Valve: First-generation TAVR system for AR or mixed AS/AR; offers six valve sizes (23–33 mm) and accommodates large or horizontal anatomies.

About Jenscare Scientific

Founded in 2011, Jenscare Scientific Co., Ltd. develops innovative interventional solutions for tricuspid, mitral, and aortic valve diseases. The company continues to expand its international clinical programs and product adoption, building a strong foundation for global growth in the structural heart field.

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