BioMatrix

Main information

  • Trade name:
  • BioMatrix Flex Drug 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:
  • BioMatrix Flex Drug 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:
  • 216541
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216541

Cardinal Health Australia 503 Pty Ltd - BioMatrix Flex Drug Eluting Coronary Stent System - Drug-eluting

coronary artery stent, biodegradable-polymer-coated

ARTG entry for

Medical Device Included Class III

Sponsor

Cardinal Health Australia 503 Pty Ltd

Postal Address

Level 5 - 7 Eden Park Drive,North Ryde, NSW, 2113

Australia

ARTG Start Date

24/10/2013

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

Biosensors Europe SA

Rue de Lausanne 29

Morges, , 1110

Switzerland

Products

1. BioMatrix Flex Drug Eluting Coronary Stent System - Drug-eluting coronary artery stent,

biodegradable-polymer-coated

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

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

Functional description

A balloon expandable intra-coronary 316L stainless steel stent with a biodegradable polymer coating

(PLA) containing Biolimus A9 pre-mounted onto a semi-compliant rapid exchange balloon catheter.

Intended purpose

The BioMatrix Flex DES is indicated for improving coronary luminal diameter for the treatment of de novo

lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm.

Stents with length 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and

3.5 mm. The BioMatrix Flex DES with stent length up to 28 mm is also indicated for use in the following

subsets of patients diagnosed for coronary artery stenting:

· ST Elevated Myocardial Infarction (STEMI)

· Acute Coronary Syndromes (ACS) including ACS-STEMI, ACS-NSTEMI and Unstable Angina

· Diabetes Mellitus

Variant information

Diameter (mm) 2.25 mm to 4.0 mm

Length (mm) 8 mm to 36 mm

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 04:56:20 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