【 Table 2. Najuta TEVAR experience at Kurume University hospital】
Patient characteristics

Mid-term outcomenn（%）, n = 29

Period2007 - 2016

Follow-up period

53.9（2 - 103）months

Patients

29

All-cause mortality

5（17）Sex (M / F)

27 / 2

Aneurysm-related mortality

0（0）Age74 (61 - 85) yr

Open conversion

1（3）Re intervention

1（3）Etiology
Degenerative

22 （Saccular 19）

Type I / III EL

1 / 1（7）Dissection

6 （Double barrel 3）

Aneurysm expansion2（7）Pseudo1Migration

0（0）Type Ia EL p/o TEVAR

5 （Homemade）Obstruction of Arch vessel

1（3）; LSA

Advantage ofCases

TEVAR of the distal arch saccular aneurysm using Najuta fenestrated Stent Graft.

Note:Data as shown below tables was including some cases of outside IFU and this does not recommend to use, refer to IFU booklet supplied with device.

Seĳi Onitsuka, MD, PhD

Kurume University, School of Medicine Department of Surgery, Division of Cardiovascular
1994 MD, Kurume University, School of Medical Department
2005 PhD, Kurume University, School of Medical Department
2006 Board Certified Surgeon in Cardiovascular Surgery
2013 Lecturer, Kurume University, School of Medicine Department of Surgery
Board certified supervising surgeon of the Japanese committee for Stentgraft (thoracic & abdominal)

Introduction
Najuta Thoracic Stent Graft System (Kawasumi Laboratories, Inc, Tokyo, Japan)
is a fenestrated endograft developed to treat thoracic aneurysm of the distal arch.
It is the only commercially available fenestrated device indicated for thoracic
endovascular aneurysm repair (TEVAR), that obtained Japanese regulatory

Manufactured by

NJT-CR0-2110-02E

Distributed byapproval in 2013 and CE mark in 2017.

DeviceSemi-order made system

Total 1,590 types of device specification
are available dependent on skeleton frame
patterns, graft size and fenestration patterns,
according to patientʼs anatomy.
▶

Advantage of Najuta Stent Graft

Najuta is effective for the lesion at lesser curvature of aortic arch where TEVAR is occasionally notable to be performed with general tube-type stent graft due to short proximal neck. On the otherhands, such aneurysm is able to be treated with Najuta due to longer landing zone and increased
proximal neck length thanks to fenestration.

Skeleton frame (Stainless steel):
64 types of 3D dimensional frame.

▶

Graft (PTFE):

Diameter ranges from 24 mm to 42 mm, for 20 mm to 38 mm aorta. Straight type and Taperedtype(4mm or 6mm) are available.

▶

Fenestration:

One to three fenestrated designed depending on patientʼs anatomy and aneurysm location.

Simulation test

An endograft is assembled and deployed into 3D-printed vessel model prior to production of actualdevice. Device configuration and fenestration positions are adjusted dependent on the result.

Tube SGFenestrated SG

Increasedproximal neck
Najuta's proximal necklength is measured as"shortest distance fromfenestration to aneurysm

Short proximal
neck & landingzone

Longerlanding zone
NajutaTube SGLow-proﬁle sheath

Diameter of delivery sheath is 21F to 23F at proximal part where device is loaded, distal part is 18F.
OD 21F to 23F

OD 18F

Clinical experience

The proximal neck length of the past twenty-nine arch TEVAR cases performed with Najuta atKurume University hospital were retrospectively reviewed. If common thoracic stent graft had beenused for these cases, the average of proximal neck length would be calculated to be 16.8±6.5mm.
However, for Najuta Stent Graft it is actually 24.9±6.7mm. These data show that Najuta is able
to significantly increase proximal sealing neck length compared to other devices.

【 Table 1. Comparison of proximal neck length】
Tube SGNajuta

PLength（mm）

16.8 ± 6.5

24.9 ± 6.7<.0001（range）（5.9 – 31.5）（14.3 – 43.7）> 20 mm Cases, N（%）

10（37%）

20（83%）

0.0006< 15 mm Cases, N（%）

13（48%）

1（4%）

0.0002