Accero® Stent - Stent, vascular, intracranial

Australia - English - Department of Health (Therapeutic Goods Administration)

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AA-Med Pty Ltd
Class III
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


AA-Med Pty Ltd - Accero® Stent - Stent, vascular, intracranial

ARTG entry for

Medical Device Included Class III


AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Acandis GmbH

Theodor-Fahrner-Strasse 6

, Pforzheim, 75177



1. Accero® Stent - Stent, vascular, intracranial

Product Type

Single Device Product

Effective date



46352 Stent, vascular, intracranial

Functional description

Accero® is a self-expanding, braided, fully radiopaque stent with three additional radiopaque markers at

both the distal and proximal end of the stent and one radiopaque marker in the middle of the stent. The

stent is preloaded onto a transport wire with an introducer. The J-tip of the transport wire, as well as one

distal and one proximal transport wire marker are also radiopaque. The distal transport wire marker

indicates until where it is possible to reposition the stent.

Intended purpose

The Accero® stent is intended for use with embolisation materials in the treatment of intracranial


Variant information

Length (mm) 10-25

Diameter (mm) 2.5-4.5

Specific Conditions

© 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

Public Summary

Page 1 of

Produced at 02.11.2019 at 07:19:15 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.

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