Zenith

Main information

  • Trade name:
  • Zenith Alpha Thoracic Endovascular Graft Distal Component - Graft, vascular, synthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Zenith Alpha Thoracic Endovascular Graft Distal Component - Graft, vascular, synthetic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222526
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222526

William A Cook Australia Pty Ltd - Zenith Alpha Thoracic Endovascular Graft Distal Component - Graft,

vascular, synthetic

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

15/04/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

William Cook Europe A/S

Sandet 6

, Bjaeverskov, DK 4632

Denmark

Products

1. Zenith Alpha Thoracic Endovascular Graft Distal Component - Graft, vascular, synthetic

Product Type

Single Device Product

Effective date

15/04/2014

GMDN

35281 Graft, vascular, synthetic

Functional description

The Zenith Alpha Thoracic Endovascular Graft Distal Component is to be overlapped within the proximal

component by at least three stents; therefore the three most proximal stents of the distal component are

located internal to the graft material to promote sealing between the proximal and distal component. It is a

woven polyester graft supported by nitinol stents. It is fully stented to provide stability and the expansile

force necessary to open the lumen of the stent graft during deployment.

Intended purpose

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

repair, including:

a) Iliac/femoral anatomy that is sutiable for access with the required introduction systems,

b) Non-aneurysmal aortic segments (fixation sites) proximanl 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

Variant information

Guage (French) Introduction System 16 to 18 (3

sizes in total)

Length (mm) 142 to 229 (10 sizes in total)

Diameter (mm) 28 to 46 (10 sizes in total)

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 09.11.2017 at 09:12:36 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information