LeMaitre XenoSure Mode D'emploi page 4

the possible risk of late tissue deterioration.
3. Animal studies with bovine pericardium have reported calcification
and histological signs of deterioration as an adverse reaction. Findings
include phagocytosis with accompanying chronic inflammatory
infiltrate at the interface between bovine pericardium and surrounding
host tissue with focal degradation of implant collagen consistent with
host vs. graft reaction.
4. Bovine pericardium used for pericardial closure has been associated
with epicardial inflammatory reactions and adhesions of the patch to
the heart. Pericardial adhesions may increase the difficulty of repeat
sternotomy.
How Supplied
One XenoSure Biologic Patch is provided sterile and non-pyrogenic in a
sealed container; DO NOT RESTERILIZE. The patch is stored in a sterile phos-
phate buffered saline solution containing 0.2% glutaraldehyde. Sterility is
assured if the package is unopened and undamaged seal. Unused sections
should be considered non-sterile and discarded.
Directions For Use
Choose the required XenoSure Biologic Patch model as appropriate for the
type of procedure being performed. The XenoSure Biologic Patch can be
cut to a size appropriate for a given repair. XenoSure Biologic Patch is for
SINGLE USE ONLY.
Patch Preparation
Surgical gloves must be thoroughly washed to remove all powder residues
before handling the XenoSure Biologic Patch.
Examine the information of the jar label to verify selection of the correct
XenoSure Biologic Patch size. Carefully inspect the entire container and
tamper-evident seal for damage.
DO NOT USE THE XENOSURE BIOLOGIC PATCH IF THE JAR IS DAMAGED OR
IF THE SEAL IS BROKEN. Do not discard the product. Please contact your
distributor for further instructions.
Rinse Procedure
Remove the tamper-evident outer plastic seal and unscrew the jar cap. The
contents of the jar are sterile and must be handled aseptically to prevent
contamination. The outside of the jar is not sterile and must not enter the
sterile field.
From the jar, remove the XenoSure Biologic Patch by grasping its corners
with sterile, atraumatic forceps.
Once removed from the container, submerge the XenoSure Biologic Patch
in the sterile saline. Using the same forceps, gently agitate the XenoSure
Biologic Patch in the basin. Allow the XenoSure Biologic Patch to remain in
the rinse basin until required by the surgeon.