Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Zenith Alpha Thoracic Endovascular Graft Proximal Component - Graft,
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.
William Cook Europe A/S
, Bjaeverskov, DK 4632
1. Zenith Alpha Thoracic Endovascular Graft Proximal Component - Graft, vascular, synthetic
Single Device Product
35281 Graft, vascular, synthetic
The Zenith Alpha Thoracic Endovascular Graft Proximal Component has a rounded, atraumatic uncovered
stent at the proximal end, and an internal sealing stent with fixation barbs that protrude through the graft
material for alignment and added fixation. It is a woven polyester graft supported by nitinol stents. The
graft is fully stented to provide stability and the expansile force necessary to open the lumen of the stent
graft during deployment.
The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with
aneurysm/ulcer of the descending thoracic aorta having vascular morphology suitable for endovascular
a) Iliac/femoral anatomy that is sutiable for access with the required introduction systems,
b) Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer:
With a length of at least 20mm
With a diameter measured outer wall to outer wall of no greater than 42mm and no less than 15mm
Length (mm) 105 to 233 (23 sizes in total)
Guage (French) Introduction System 16 to 20 (3
sizes in total)
Diameter (mm) 18 to 46 (15 sizes in total)
No Specific Conditions included on Record
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