Najuta Thoracic Stent Graft System

Product Name Najuta Thoracic Stent Graft System
Available Markets CE mark approval / Japanese MHLW approval
Sterilization Sterilized by Ethylene Oxide Gas
Stent Material Stainless steel
Graft Material PTFE
SG Length 102-178mm
SG Diameter Straight type (24,26,28,30,32,34,36,38,40,42mm)
Tapered type (28,30,32,34,36,38,40,42mm)
Delivery Sheath 21-23Fr (O.D)

Animation(Deployment Techniques)

Features

  • Features1

    Semi-custom-made
    The Najuta is a semi-custom-made stent graft having a variety of three-dimensional structures, which enables to provide a suitable stent graft matching with a patient's anatomy of the aorta. Pre-shaped structuring prevents mal-sealing adhesion on lesser curvature (Bird Beak).

  • Features2

    Fenestrations
    The Najuta has single or multiple fenestrations created along its greater curvature to secure blood supply via the arch vessels. It enables to obtain enough sealing / landing zone and enlarge applicable zone on lesser curvature where aneurysms often occur.

Clinical Trial Data

End Point Result
Main Endpoint Survival rate at 12 months after aneurysm-related treatment 97.3% (108/111)
Safety Evaluation Major complication incidence 18.8%(22/117)
Survival rate at 12 months postoperative 95.7%(112/117)
Clinical Benefit Operation time 136.0±53.0min
ICU stay 0.85±0.93day
Oral ingestion limited time 1.16±0.63day
Hospitalization(Operation-Discharge) 12.1±6.6day
Others Condition of stent graft
(at after 12 months)
Migration 0%(0/117)
Device deformation/breakage 0%(0/117)
Aneurysm size
(at after 12 months)
Expansion 6.0%(7/117)
Shrinkage 29.9%(35/117)
Not changed 53.8%(63/117)
No CT data 10.3%(12/117)