Axograft Logo
PMS 485 Red
&
PMS 294 Blue
Dual Layer Amniotic Membrane
Amnion is the placental tissue that surrounds and protects the fetus during development in utero.
The properties of amnion that benefit the fetus also make it an effective material for protecting
a wide variety of wounds, while at the same time creating an environment conducive to the
regeneration of healthy tissue. Repurposing this versatile tissue to improve outcomes in wound
management is supported by studies in published literature which describes its successful and
safe clinical use.
Amnion consists primarily of fibrillar and membranous collagens, elastin, and a mix of growth
factors and cytokines that provide the properties unique to placental tissues.
The Benefits of Amnion
The scientific and peer reviewed literature describe a number
of benefits from the clinical use of amnion tissues
1
, including:
Safe, natural covering that improves normal wound healing outcomes
Reduced inflammation
Reduced fibrosis and scarring at the surgical site
Decreases pain
Provides a substrate for stem cells
Uses of Amnion
Specifically, amnion has been used to achieve the following outcomes
1
:
Inhibit fibrogenesis (scarring) when applied topically to dermal
and subcutaneous wounds
Prevent adhesions tethered to implanted hardware
Reduce the occurrence of dural & nerve root adhesions
Prevent adhesions in tendon grafts and repair
Amnion has been used successfully in many clinical applications:
Spine / neurologic surgeries
Orthopedics
Sports medicine
Trauma
Cranio maxillofacial surgery
Podiatric surgery
1: Though well documented in the
clinical literature, these benefits of
amnion have not been studied
using Axograft™ products.
F-1000.41 Rev B 9/14
X-spine Systems, Inc.
452 Alexandersville Rd., Miamisburg, OH 45342
Phone: 800-903-0640 • Direct: 937-847-8400
Fax: 937-847-8410 • www.x-spine.com
INDICATIONS: See Package Insert for a more complete listing of indications, contraindications,
warnings, precautions, and other important information.
LIMITED WARRANTY and DISCLAIMER: X-spine products have a limited warranty against defects
and workmanship and materials. Any other express or implied warranties, including warranties of
merchantability or fitness, are disclaimed.
WARNING: In the USA, this product has labeling limitations.
See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the order of a physician.
X-spine
SM
, the X-spine logo, the Axograft™ logo,
and Axograft™ mark are all trademarks or service
marks of X-spine Systems, Inc.
The “Axograft” name is a registered trademark of
X-spine Systems, Inc.; and represents products supplied
by Bone Bank Allografts.
Patents Pending.
All products are not currently available in all markets.
© 2014 X-spine Systems, Inc., All rights reserved.
Part #
Description
X090-0025-AMN22CMCC
2 x 2cm Amniotic Membrane, Axograft
X090-0025-AMN44CMCC
4 x 4cm Amniotic Membrane, Axograft
X090-0025-AMN46CMCC
4 x 6cm Amniotic Membrane, Axograft
X090-0025-AMN48CMCC
4 x 8cm Amniotic Membrane, Axograft
Advantages of Axograft
™
Amniotic Membrane
Stores dry at room temperature
Suitable for immediate use off the shelf
Hydrates rapidly in wound environment
Readily adheres to the wound surface
Terminally sterilized with gamma radiation to
SAL 10
-6
in accordance with ISO 11137
Not chemically cross-linked
Three year shelf life
Axograft
™
Amniotic Membrane (Dual Layer)
version processed with surface layer dimpling
for ease of graft placement / handling
Axograft
™
Amniotic Membrane (Dual Layer)
version can be placed with either side in contact
with wound surface
Tissue Safety
Collection of the donor tissue is performed in
an aseptic manner by appropriately licensed
tissue establishments
Placentas are all from planned C-sections
which helps to minimize the potential for
contamination during recovery
Placental donors go through a rigorous
pre-screening qualification
Placental donors are tested to confirm
they are free from disease
Processed in accordance with the safety
guidelines provided by the U.S. Food and
Drug Administration (FDA) - Human Cellular
and Tissue-based Products (HCT/P)
(21 CFR Part 1271)
Processed in accordance with the standards
from the American Association of Tissue Banks
(AATB)
Select IFUs
Maintain allograft in a clean, dry
environment at room temperature
(15°C/59°F to 30°C/86°F)
No refrigeration is necessary
Apply dry with forceps
Axograft
™
Amniotic Membrane (Dual Layer)
construction removes the requirement to apply
with one side towards the wound (stromal layer)
and a different side (epithelial layer) out
If not initially placed properly during surgery,
the Axograft
™
Amniotic Membrane (Dual Layer)
graft can either be manipulated in place or
removed; when placed in water or saline, the
graft will unfold and can be repositioned