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XenoSure® Biologic Patch
(Model Numbers 0.6P8, 0.8P8, 1P6, 1P10, 1.5P10, 1P14, 2P9, 4P4, 4P6,
6P8, 8P14, 10P16)
Processed bovine pericardial patch
Instructions for use - English
Storage
The XenoSure® Biologic Patch should be stored above 0°C (32°F). Avoid
locations where extreme temperature fl uctuations may occur; for example,
near steam or hot water pipes, air conditioning ducts, or in direct sunlight.
REFRIGERATION IS NOT REQUIRED. FREEZING WILL SERIOUSLY DAMAGE THE
XENOSURE BIOLOGIC PATCH AND RENDER IT UNFIT FOR USE.
Device Description
The XenoSure Biologic Patch consists of one piece of bovine pericardial
tissue that has been selected for minimal tissue blemishes. The tissue is
treated with a glutaraldehyde process which crosslinks the collagen fi bers
and minimizes antigenicity. The XenoSure Biologic Patch is liquid chemical
sterilized and packaged in a plastic jar containing sterile glutaraldehyde
storage solution. The XenoSure Biologic Patch is designed to repair the
body's natural organs.
The XenoSure Biologic Patches come in the following sizes:
Model
Size (cm)
Model
0.6P8
0.6x8
2P9
0.8P8
0.8x8
4P4
1P6
1x6
4P6
1P10
1X10
6P8
1.5P10
1.5X10
8P14
1P14
1x14
10P16
Indications For Use in Australia
The XenoSure Biologic Patch is intended for use as a surgical patch material
for cardiac and vascular reconstruction and repair.
Indications For Use in Other Countries
The XenoSure Biologic Patch is intended for use as a surgical patch material
for cardiac and vascular reconstruction and repair, soft tissue defi ciency
repair, reinforcing the suture line during general surgical procedures, and to
close dura mater during neurosurgery.
The indication of "close dura mater during neurosurgery" is not approved by
the French authorities in the French Republic.
Contraindications
None known.
Potential Complications
• Restenosis
• Pseudoaneurysm formation
• Infection
• Thrombosis
• Calcifi cation
• Fibrosis
• Vessel occlusion
• Patch rupture
• Dilatation
• Myocardial infarction
• Bleeding
• Cerebrospinal fl uid leakage
• Stroke
• Death
• Meningitis
Warnings
The principal complications that have been reported for bovine pericardial
tissue are fi brosis and infection. These complications are observed only in
a small minority of patients after implantation of the bovine pericardial
tissue.
Precautions
All persons responsible for the handling and preparation of the XenoSure
Biologic Patch must exercise utmost care to avoid damage to the XenoSure
Biologic Patch tissue.
3
Size (cm)
2x9
4x4
4x6
6x8
8x14
10x16
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