Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Zenith Renu AAA Ancillary Graft Main Body Extension - Graft, vascular,
ARTG entry for
Medical Device Included Class III
William A Cook Australia Pty Ltd
95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
750 Daniels Way
Bloomington, Indiana, 47404
United States Of America
1. Zenith Renu AAA Ancillary Graft Main Body Extension - Graft, vascular, synthetic
Medical device system
35281 Graft, vascular, synthetic
The Zenith Renu AAA Z-Trak Ancillary Graft Main Body Extension is a woven polyester graft supported by
stainless steel Z-stents. Each graft is loaded into a hydrophilic delivery sheath. It is introduced
percutaneoulsy and deployed using a trigger wire system.
The Zenith Renu AAA Ancillary Graft Main Body Extension with the Z-Trak Introduction System is
indicated for secondary endovascular intervention in patients having received prior endovascular repair of
infrarenal abdominal aortic or aortoiliac aneurysms in which there is inadequate proximal fixation or seal
a) adequate iliac/femoral access compatilble with the required introduction systems,
b) adequate proximal fixation site:
c) with a length from the lowest renal artery to the bifurcation of the previously placed endovascular graft of
>43mm for the main body extension
d) with a diameter measured outer wall to outer wall of >18mm and <32mm
e) with an angle <60 degrees relative to the long axis of the aneurysm, and
f) with an angle of <45 degrees relative to the axis of the suprarenal aorta
g) adequate distal fixation site for the main body extension, distal fixation site within a graft segment of
<34mm in diameter and one Cook-Z stent in length, with more overlap length being preferred.
Diameter (mm) 22-36 (7 sizes in total)
Length (mm) 43-100 (Graft length 6 sizes in total)
No Specific Conditions included on Record
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