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)

• MRI Information
• Information For Patients

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)