iStent

Main information

  • Trade name:
  • iStent Trabecular Micro Bypass Stent System - Glaucoma shunt
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • iStent Trabecular Micro Bypass Stent System - Glaucoma shunt
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219246
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219246

RQSolutions Medical Devices Distribution Support - iStent Trabecular Micro Bypass Stent System -

Glaucoma shunt

ARTG entry for

Medical Device Included Class III

Sponsor

RQSolutions Medical Devices Distribution Support

Postal Address

4 Warrah Street,CHATSWOOD, NSW, 2067

Australia

ARTG Start Date

15/01/2014

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

Glaukos Corporation

229 Avenida Fabricante

San Clemente, CA, 92672

United States Of America

Products

1. iStent Trabecular Micro Bypass Stent System - Glaucoma shunt

Product Type

Single Device Product

Effective date

15/01/2014

GMDN

61127 Glaucoma shunt

Functional description

The stent is designed to keep open a passage through the trabecular meshwork in order for aqueous to

flow from the anterior chamber into Schlemm's canal, where the fluid is naturally directed to normal outflow

channels. The stent is to be placed within Schlemm's canal and the trabecular meshwork to reduce

intraocular pressure

Intended purpose

The iStent Trabecular Micro-Bypass System is intended to reduce intraocular pressure in adult patients

diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular

hypotensive medication. The device can be implanted with or without cataract surgery.

Variant information

Model number (see guidance docs) GTS100R

Model number (see guidance docs) GTS100L

Shape (of tip) Right tip for right flow

Shape (of tip) Left tip for left flow

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 08:07:47 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

4-10-2018

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31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

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FDA - U.S. Food and Drug Administration

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

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Europe - EFSA - European Food Safety Authority EFSA Journal

14-6-2018

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France - Agence Nationale du Médicament Vétérinaire

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

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FDA - U.S. Food and Drug Administration

22-5-2018

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The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

25-4-2018

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13-6-2017

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Danish Medicines Agency

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