en
CAUTION: Please read all instructions prior to use.
PRODUCT DESCRIPTION
A
VITENE
™ U
LTRAFOAM
™ is an absorbable hemostatic sponge prepared as a sterile, porous, pliable,
water insoluble partial hydrochloric acid salt of puri
fi
ed bovine corium collagen. In its manufacture,
swelling of the native collagen
fi
brils is controlled by ethyl alcohol to permit noncovalent attachment
of hydrochloric acid to amine groups on the collagen molecule and preservation of the essential
morphology of native collagen molecules. The characteristics of collagen which are essential to its
effect on the blood coagulation mechanisms are preserved, although dry heat sterilization causes
some cross-linking which is evidenced by reduction of hydrating properties, and a decrease of
molecular weight which implies some degradation of collagen molecules.
ACTION
A
VITENE
™ U
LTRAFOAM
™
sponge, in contact with a bleeding surface, attracts platelets which then
undergo the release phenomenon to trigger aggregation of platelets into thrombi in the interstices of
the
fi
brous mass. It is able to absorb and hold within its interstices many times its weight of blood and
other
fl
uids. When implanted in animal tissues, it is absorbed in 90 days.
DOSAGE AND ADMINISTRATION
Only the amount of material necessary to control bleeding should be used. A
VITENE
™ U
LTRAFOAM
™
sponge should be cut to the desired size and applied directly to the source of bleeding. Hold A
VITENE
™
U
LTRAFOAM
™ sponge in place with moderate pressure until hemostasis results. The period of time to
hold pressure will vary with the force and severity of bleeding. A
VITENE
™ U
LTRAFOAM
™
sponge may
be left in place at the bleeding site when necessary. Prior to removal, moisten A
VITENE
™ U
LTRAFOAM
™
sponge with saline to avoid dislodging the clot.
INDICATIONS
A
VITENE
™ U
LTRAFOAM
™
sponge is indicated in surgical procedures as an adjunct to hemostasis when
control of bleeding by ligature or conventional procedures is ineffective or impractical.
CONTRAINDICATIONS
• A
VITENE
™ U
LTRAFOAM
™ sponge should not be used in the closure of skin incisions as it may interfere
with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen
and not due to any intrinsic interference with wound healing.
• It has been reported with other collagen hemostatic agents, that by
fi
lling porosities of cancellous
bone, they may signi
fi
cantly reduce the bond strength of methylmethacrylate adhesives. A
VITENE
™
U
LTRAFOAM
™
sponge should not, therefore, be employed on bone surfaces to which prosthetic
materials are to be attached with methylmethacrylate adhesives.
WARNINGS
• A
VITENE
™ U
LTRAFOAM
™ sponge is inactivated by autoclaving.
• Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
• This device has been designed for single use only. Reuse, reprocessing, resterilization or
repackaging may compromise the structural integrity and/or essential material and design
characteristics that are critical to the overall performance of the device and may lead to
device failure which may result in injury to the patient.
Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination
of the device and/or cause patient infection or cross infection, including, but not limited
to, the transmission of infectious diseases from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient or end user. Opened, unused
product should be discarded.
• As with any foreign substance, use of A
VITENE
™ U
LTRAFOAM
™ sponge in contaminated
wounds may enhance infection.
• A
VITENE
™ U
LTRAFOAM
™ sponge should not be used in instances of pumping arterial
hemorrhage.
• It should not be used where blood or other
fl
uids have pooled, or in cases where the point
of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in
hematoma.
• A
VITENE
™ U
LTRAFOAM
™ sponge will not act as a tampon or plug in a bleeding site, nor will it
close off an area of blood collecting behind a tampon.
PK3795633 BAW-8.indd 2
PK3795633 BAW-8.indd 2
9/7/2011 7:44:06 AM
9/7/2011 7:44:06 AM
