Summary for ARTG Entry:
Device Technologies Australia Pty Ltd - E-vita open plus TAA Stent Graft System - Graft, vascular,
ARTG entry for
Medical Device Included Class III
Device Technologies Australia Pty Ltd
Locked Bag 521,FRENCHS FOREST, NSW, 2086
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.
, Hechingen, 72379
1. E-vita open plus Stent Graft System - Graft, vascular, synthetic
Medical device system
35281 Graft, vascular, synthetic
The E-vita open plus delivery system with loaded stentgraft is introduced into the aorta through a median
sternotomy using a guide wire and advanced up to the implantation site.The self-expanding mechanism of
the E-vita open plus stentgraft is triggered by retracting the outer shell of the delivery system.The
stentgraft adapts itself to the shape and size of the sealing zone.
The E-vita open plus Stent Graft System is indicated for the treatment of aneurysms, dissections and
specific lesions of the thoracic aorta.
Diameter (mm) Stent Graft Diameter 20-40
Length (mm) Stent Graft Length 80-240
Width (mm) Collar Width 2-40
Shape With Collar / Without Collar
No Specific Conditions included on Record
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Produced at 21.11.2017 at 09:31:17 AEDT
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