Dual Layer Amniotic Membrane



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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

 

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