Orsiro

Main information

  • Trade name:
  • Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220414
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220414

Biotronik Australia Pty Ltd - Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery

stent, biodegradable-polymer-coated

ARTG entry for

Medical Device Included Class III

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

24/02/2014

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

Biotronik AG

Ackerstrasse 6

, Bulach, CH-8180

Switzerland

Products

1. Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent,

biodegradable-polymer-coated

Product Type

Single Device Product

Effective date

24/02/2014

GMDN

58771 Drug-eluting coronary artery stent, biodegradable-polymer-coated

Functional description

Intended to improve coronary luminal diameter where symptomatic ischemic heart disease is due to

coronary artery lesions. A balloon expandable stent coated with PLLA/ Sirolimus matrix, pre-mounted on a

fast exchange PTCA catheter . (Diameters of 2.25, 3.0, 3.5 & 4.0 mm it contains 1.4 ?g Sirolimus / mm²).

To aid positioning, it is centred between two radiopaque markers. Indicating when the delivery system tip

exits from the guiding catheter, markers - 92 cm and 102 cm from the distal end.

Intended purpose

The Orsiro Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter

in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent

restenotic lesions (length ? 30 mm) in native coronary arteries with a reference vessel diameter of 2.25

mm to 4.0 mm.

Variant information

Diameter (mm) stent diameter 2.25 - 4.0

Length (mm) stent length 9 - 30

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 04:09:40 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