Summary for ARTG Entry:
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
Cardinal Health Australia 503 Pty Ltd
Level 5 - 7 Eden Park Drive,North Ryde, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Biosensors Europe SA
Rue de Lausanne 29
Morges, , 1110
1. BioMatrix Flex Drug Eluting Coronary Stent System - Drug-eluting coronary artery stent,
Single Device Product
58771 Drug-eluting coronary artery stent, biodegradable-polymer-coated
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.
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
Diameter (mm) 2.25 mm to 4.0 mm
Length (mm) 8 mm to 36 mm
No Specific Conditions included on Record
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