Zenith

Main information

  • Trade name:
  • Zenith Renu AAA Ancillary Graft Main Body Extension - Graft, vascular, synthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Zenith Renu AAA Ancillary Graft Main Body Extension - Graft, vascular, synthetic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216477
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216477

William A Cook Australia Pty Ltd - Zenith Renu AAA Ancillary Graft Main Body Extension - 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

23/10/2013

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

Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America

Products

1. Zenith Renu AAA Ancillary Graft Main Body Extension - Graft, vascular, synthetic

Product Type

Medical device system

Effective date

23/10/2013

GMDN

35281 Graft, vascular, synthetic

Functional description

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.

Intended purpose

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

with:

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.

Variant information

Diameter (mm) 22-36 (7 sizes in total)

Length (mm) 43-100 (Graft length 6 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 10.11.2017 at 05:03:32 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