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Idiomas disponibles
Idiomas disponibles
XenoSure® Biologic Patch
(Model Numbers 0.6BV8, 0.8BV8, 1BV6, 1BV10, 1.5BV10, 1BV14, 2BV9, 4BV4, 4BV6, 6BV8,
8BV14, 10BV16)
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 fluctuations 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. FREEZ-
ING 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 fibers 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:
Indications For Use
The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac and
vascular reconstruction and repair, soft tissue deficiency 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
• Calcification
• Fibrosis
• Vessel occlusion
• Patch rupture
• Dilatation
• Myocardial infarction
• Bleeding
• Cerebrospinal fluid leakage
• Stroke
• Death
Model
Size (cm)
0.6BV8
0.6x8
0.8BV8
0.8x8
1BV6
1x6
1BV10
1X10
1.5BV10
1.5X10
1BV14
1x14
Model
Size (cm)
2BV9
2x9
4BV4
4x4
4BV6
4x6
6BV8
6x8
8BV14
8x14
10BV16
10x16
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