Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese‑developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.
Regulatory Milestone
Item
Detail
Company
Jenscare Scientific Co., Ltd. (HKG: 9877)
Agency
U.S. Food and Drug Administration (FDA)
Asset
LuX-Valve Plus – Transcatheter tricuspid valve replacement (TTVR) system
Approval
IDE clearance for pivotal regulatory study
Target Population
Severe tricuspid regurgitation, high surgical risk
Global Implant Record
Multiple successful cases worldwide with demonstrated safety/efficacy
Technology Platform & Design Innovation
Feature
Technical Specification
Clinical Advantage
Anchoring Mechanism
Interventricular septal anchoring
Eliminates need for radial force against fragile tricuspid annulus, reducing perforation risk
Anti-Leak Design
Adaptive valve ring
Conforms to irregular annular anatomy, minimizing paravalvular leak
Delivery Approach
Transjugular venous access
Avoids sternotomy and cardiopulmonary bypass; enables truly percutaneous procedure
Size Range
Multiple valve sizes
Accommodates diverse patient anatomies and right ventricular dimensions
Target Indication & Market Opportunity
Tricuspid Regurgitation Burden: Severe TR affects >1.6 million patients in the US alone, with <1% receiving surgical intervention due to high operative mortality in elderly/comorbid populations.
Structural Heart Gap: TTVR represents the final frontier of transcatheter valve therapy; while TAVR (aortic) and TMVR (mitral) are established, tricuspid solutions remain limited—creating first-mover premium pricing potential.
LuX-Valve Plus Differentiation: Unlike Edwards EVOQUE (annular anchoring) and Abbott TriClip (leaflet repair), LuX-Valve Plus’s septal anchoring addresses extreme right atrial dilation cases where traditional approaches fail.
Strategic Positioning & Competitive Landscape
Competitor
Product
Mechanism
LuX-Valve Plus Advantage
Edwards Lifesciences
EVOQUE
Annular‑anchored TTVR
Septal fixation for severely dilated annuli
Abbott
TriClip
Leaflet edge‑to‑edge repair
Replacement (not repair) for destroyed valves
Medtronic
Intrepid (investigational)
Transseptal mitral‑adapted
Purpose‑built tricuspid design vs. adapted mitral tech
China‑to‑Global Expansion: FDA IDE approval validates Jenscare’s US regulatory strategy and positions the company as first Chinese TTVR manufacturer to pursue US market authorization.
Hong Kong Listing Synergy:9877.HK listing provides USD capital access for US trial execution and potential US IPO pathway for commercial subsidiary.
Forward‑Looking Statements This brief contains forward‑looking statements regarding LuX-Valve Plus US pivotal trial execution, FDA PMA pathway timelines, and Jenscare Scientific’s global TTVR commercialization strategy. Actual results may differ due to trial enrollment challenges, competitive responses from Edwards and Abbott, and regulatory requirements for novel septal anchoring mechanisms.-Fineline Info & Tech
By Fineline Cube 