LeMaitre XenoSure Mode D'emploi page 2

XenoSure® Biologic Patch
(Model Numbers 0.6BV8, 0.8BV8, 1BV6, 1BV10, 1.5BV10, 1BV14, 2BV9,
4BV4, 4BV6, 6BV8, 8BV14, 10BV16, e0.6BV8, e0.8BV8, e1BV6, e1BV10,
e1.5BV10, e1BV14, e2BV9, e4BV4, e4BV6, e6BV8, e8BV14, e10BV16)
Processed bovine pericardial patch
Instructions for use - English
Storage
The XenoSure® Biologic Patch should be stored between 0°C - 40°C (32°F
- 104°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.
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:
Model
0.6BV8 e0.6BV8
0.8BV8 e0.8BV8
1BV6
1BV10 e1BV10
1.5BV10 e1.5BV10
1BV14 e1BV14
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
Size (cm)
0.6x8
0.8x8
e1BV6 1x6
1X10
1.5X10
1x14
Model
2BV9 e2BV9
4BV4 e4BV4
4BV6 e4BV6
6BV8 e6BV8
8BV14 e8BV14
10BV16 e10BV16
Size (cm)
2x9
4x4
4x6
6x8
8x14
10x16