A thin hydrophilic amniotic membrane designed to serve as a wound covering & protective

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1. What is VersaShield?

 

A thin hydrophilic amniotic membrane designed to serve as a wound covering & protective 

barrier for a variety of surgical demands. VersaShield is derived from the human placental layers 

amnion and chorion

. It is used to maintain a tissue plane between adjacent tissues or structures 

following surgery.

2. What are the indications for VersaShield?

 

VersaShield is intended for use as a wound or soft tissue covering, or protective barrier.

3. How is VersaShield Regulated?

 

VersaShield is regulated as a Human Cellular and Tissue Product (HCT/P). There is no pre-market 

approval required.

4. What are the benefits of an amnion and chorion bi-layer membrane versus  

 

amnion only? 

The chorion membrane is added to reinforce the graft. It improves the handling properties 

of the graft during implantation and helps support a longer residence time in the body 

post-implantation.

5. What is the shelf life of VersaShield?

 

VersaShield can be stored for up to 3 years at ambient temperature.

6. Does it matter if amnion is terminally sterilized? 

 

VersaShield is not terminally sterilized. It has been well-documented that terminal sterilization 

may have an adverse effect on soft tissue allografts which can reduce their efficacy

1-4

. The graft 

is aseptically processed and passes USP <71> Sterility Test.

7. I have heard that chorion has an immune response. Do you have data that 

suggests otherwise? 

The chorion membrane from this graft is from the non-vascularized portion of the placenta. It 

is immune privileged, similar to the amnion membrane, and therefore will not illicit an immune 

response. In addition, the chorion membrane represents the outer shell of the placenta, which 

is not rejected by the mother

5-7

.

8. What type of procedures would you place the graft with amnion side 

facing up? What type of procedures would you want to place the amnion 

side down?

 

When the graft is being used as wound covering, the amnion side should be placed towards 

the wound bed. When the graft is being used as a protective barrier the amnion side should  

be placed up towards the side of potential inflammation or scar tissue formation.

9. Can VersaShield be sutured or tacked down? 

Yes, VersaShield can be gently sutured, however VersaShield does not have suture retention 

strength so it should only be used for tacking in place.

 

Frequently Asked Questions

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www.orthofix.com

References:

1.   Gouk SS et al. Alteration of Human Acellular Tissue Matrix by Gamma Irradiation: Histology, Biochemical Property, Stability, In Vitro Cell Repopulation and Remodeling. 

J Biomed Mater Res Part B: Appl Biomater. 2008; 84B:205-217. 

2.   Liu B et al. The effect of gamma irradiation on injectable human amnion collagen. J Biomed Mater Res. 1989; 23:833-844.

3  Olde Damink LHH et al. Influence of ethylene oxide gas treatment on the in vitro degradation behavior of dermal sheep collagen. J Biomed Mater Res. 1995; 29:149-155.

4.   Wiegand C et al. Effect of Sterilization Method on the Performance of Collagen Type I on Chronic Wound Parameters In Vitro. J Biomed Mater Res Part B: 

Appl Biomater. 2009; 90B:710-719.

5.   Szerekes-Bartho J. Immunological relationship between the mother and the fetus. Int Rev Immunol. 2002; 21:471-495.

6.   Veenstra van Nieuwenhoven AL et al. The immunology of successful pregnancy. Human Reproduction Update. 2003; 9:347-357.

7.   Ueta M et al. Immunosuppressive properties of human amniotic membrane for mixed lymphocyte reaction. Clin Exp Immunol. 2002; 129:464-470.

8.    Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009; 18:1202-12.

9.   Meng H et al. Assessment of processed human amniotic membrane as a protective barrier in rat model of sciatic nerve injury. Neuroscience Letters. 2011; 496:48-53.

10.  Mligiliche N et al. Extracellular matrix of human amnion manufactured into tubes as conduits for peripheral nerve regeneration. J Biomed Mater Res. 2002; 63:591-600.

11.  Tomita T et al. New Dried Human Amniotic Membrane Is Useful as a Substitute for Dural Repair Skull Base Surgery.  J Neurol Surg B Skull Base. 2012; 73:302-307.

10. Should VersaShield be hydrated prior to use?

 

The tissue can be applied in its dry form. If needed, the tissue can be hydrated with sterile 

saline or sterile water prior to implantation.

11. Can VersaShield be over hydrated, if so what would happen? 

 

Too much irrigation post implantation could potentially cause the graft to shift from its position 

and should be avoided.

12. For internal wounds how long does it take for VersaShield to reincorporate? 

For internal wounds, a single layer of amnion has been shown to take at least 6-12 weeks  

to resorb in previous animal studies

8

. VersaShield which contains an amnion layer and  

a chorion layer, is expected to persist over a considerably longer period in the body since 

the thickness of the chorion layer is two to four times that of the amnion layer.

13. Can VersaShield be used as a nerve wrap or a dural covering?

 

Yes, it can be used as a nerve wrap or dural covering

9-11

. The amnion side should be placed up 

in these types of applications.

14. How often does VersaShield have to be reapplied? 

For external wounds, factors such as the wound type and location, as well as the overall 

patient health will determine how many applications of VersaShield will be needed.