Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery
ARTG entry for
Medical Device Included Class III
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
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.
, Bulach, CH-8180
1. Orsiro Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent,
Single Device Product
58771 Drug-eluting coronary artery stent, biodegradable-polymer-coated
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.
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.
Diameter (mm) stent diameter 2.25 - 4.0
Length (mm) stent length 9 - 30
No Specific Conditions included on Record
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