The preferred choicefor Frozen Elephant Trunk reconstruction
Open Stented Grafting originated in Japan isrecognized as the Frozen Elephant Trunk Technique across the world.
The case number in Japan is increasing year by year
since FROZENIX was launched in July, 2014.
The device also advances along with the accumulated experiencein clinical practice.
FROZENIXAs a supplementary device in Total Arch Replacement,
we hope FROZENIX will continue to provide a better option
for treatment of Aortic Aneurysm.

Features of FROZENIX

Along with the accumulated experience in clinical practice

Advanced Delivery System
Unique stent design
Guide Wire Lumen
Guide wire lumen added for safer
and more precise stent positioning

Hand-knitted uniquestent design that yields
flexibility

Tip with increased flexibility
Easily conforms to shape of aorta
because ofthe increased flexibility of tip

Supple yet strong enough toconform to the aortic archMarkerMarker on non-stented (graft) section,
scaled at every 1cm for more precise stent positioning

Guide Wire Lumen
Entry PortFROZENIX can be deployed in 3 easy steps.
UncaseUnpack the whole package
from the sterilization pouchand uncase FROZENIX toright above.

Tip adjustment

Deployment

Adjust the curve of the tip tofacilitate insertion of the device.

Pull the sleeve whilst holding
on to the grip.

Insertion of guide wireIf required, the guide wire isinserted here.

* recommended diameter of guide wire: 0.035 inch

Grip
New design with better handlingand slip resistanceCase Example

Acute TypeA Dissection

preoperative 3D

postoperative 3D

It is reported that FROZENIX
can produce an excellent
remodeling of the thoracicaorta.1)
Here is a case example of totalarch replacement withFROZENIX for treatment of theacute type A dissection.
The false lumen of thedescending thoracic aorta
became thrombosed after theoperation and an excellent
remodeling of the thoracic
aorta was confirmed by CT
after 6 months.

Stump Formation
It is necessary to make stumpformation at the proximal end
after the deployment of stent inorder to control the bleeding as
FROZENIX uses a non-coatedgraft (porosity: 150cc)

Aneurysm

preoperative 3D

postoperative 3D

preoperative CT

postoperative CT

Anastomosis at the distal
end of the distal arch aneurysm
can be simplified and cantreat at one time by mediansternotomy.

preoperative CT

postoperative CT

Here is a case example of totalarch replacement with FROZENIX
for treatment of the distal arch
aneurysm.
It is reported that the risk of
respiratory complications such ashoarseness and dysphagia can be
reduced as damage to a recurrent
laryngeal nerve is limited byminimum exfoliation of the aorticarch.
Also, it helps graft anastomosing at
the proximal end under good visionand makes the bleeding control
easy.

Stent Graft System (Stent Graft, Delivery System)

Stent Graft

Grip length
135mm

Cover

Total length 570mm· Graft Material :Polyester· Stent Material :Nickel-titanium alloy

Stent Material

Nickel-titanium alloy

Graft Material

Uncoated Polyester

MR Safety

MR Conditional
FROZENIX can be scanned safely under static magnetic field of 3.0 Tesla or less.

Durability

After 380 million cycles (equivalent to 10 years) of pulsatile test,
no breakage, damage, or deformation was observed (according to JIS T 0401:2013).
The graft is loaded between a bendable rod and a cover;therefore, the curve of the tip is adjustable.

RodTotal length

200mm

Stent length

60mm

90mm

120mm

150mm

21mm

FRZX-_21060

FRZX-_21090

FRZX-_21120—23mm

FRZX-_23060

FRZX-_23090

FRZX-_23120

FRZX-_23150

25mm

FRZX-_25060

FRZX-_25090

FRZX-_25120

FRZX-_25150

27mm

FRZX-_27060

FRZX-_27090

FRZX-_27120

FRZX-_27150

29mm

FRZX-_29060

FRZX-_29090

FRZX-_29120

FRZX-_29150

31mm

FRZX-_31060

FRZX-_31090

FRZX-_31120

FRZX-_31150

33mm

FRZX-_33060

FRZX-_33090

FRZX-_33120

FRZX-_33150

35mm

FRZX-_35060

FRZX-_35090

FRZX-_35120FRZX-_35150

37mm

FRZX-_37060

FRZX-_37090

FRZX-_37120

FRZX-_37150

39mm

FRZX-_39060

FRZX-_39090

FRZX-_39120

FRZX-_39150

Outer diameter

Note: Catalogue numbers are subject to countries.

2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002 Japan
http://www.japanlifeline.com
2021-08-00-01-JLL-HP