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Preserving All Native Layers Matters
Epithelium – Contains higher levels of specific growth factors/cytokines than other layers.6 Also a rich source of mesenchymal stem cells (MSCs).7, 8
Basement membrane– Composed of collagens and noncollagenous glycoproteins.4
Compact layer – Forms the main fibrous structure of the amnion.9
Contain growth factors and cytokines9
Reticular layer– Composed of collagens and forms the majority of the chorion’s thickness,4, 11 which results in a thick graft with easy handling characteristics.12
Fibroblast layer– Thickest layer of amnion and consists of fibroblasts embedded in loose collagen network.4
Intermediate (spongy) layer – Contains higher levels of specific growth factors than other layers.10 Also an abundant source of hydrated proteoglycans, Type III collagen, TGF-ß1, HGF, and hyaluronic acid, which have been shown to be beneficial in the wound-healing process.6-8
Basement membrane – Anchors trophoblasts to the reticular layer with collagen IV, fibronectin, and laminin.4, 11
Support Wound Healing with NuShield
NuShield is a sterilized, dehydrated placental allograft designed to protect and support healing. It offers a complete, convenient, and valuable solution with the versatility you and your patients need.
Choose the More Complete Option
The proprietary process for NuShield preserves the native amnion and chorion with the spongy/ intermediate layer intact, unlike many others on the market.5, 13
NuShield also undergoes less manipulation than other dehydrated amniotic allografts.12
NuShield also contains key components known to be important in the wound-healing process,9 including extracellular matrix (ECM) proteins, growth factors and cytokines.
Preserve the Spongy Layer
An in vitro study has shown that the NuShield spongy layer contains the following substances:12
Preserve the Spongy Layer
The proprietary process for NuShield preserves numerous growth factors and cytokines with angiogenic, regenerative, and anti-inflammatory properties
In Vitro Study Demonstrating the Releas of NuShield Growth Factors/Cytokines12
Complete to Protect and Support Healing
- The proprietary process for NuShield retains all layers of the native ECM, including the spongy layer
Convenient for All Situations
- 5 year shelf life at room temperature
- Multiple sizes and configurations
- Can be used for various wound types from head to toe, including those with exposed bone and tendon
Assurance of Safety
- Donor screening and testing per FDA and AATB standards
- Aseptically processed per FDA and AATB standards
- Terminally sterilized with a Sterility Level Assurance (SAL) of 10-6
Added Value with Added Support
- Reimbursed by CMS as a skin substitute in the high bundle
- Supported by a wide range of customer programs and services
- Mowry KC et al. Novel processing techniques to preserve tissue structure and integrity of amniotic membrane and a comparison to dehydrated amnion-chorion grafts in a rodent animal model. Poster presented at SAWC, Fall 2015
- Koob TJ et al. Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. 2014. J Biomed Mater Res Part B 2014:102B:1353–1362
- Data on file. Organogenesis Inc.
- McQuilling JP et al. Proteomic Comparison of Amnion and Chorion and Evaluation of the Effects of Processing on Placental Membranes. Wounds. 2017;29(5):E36-E40
- Cooke M et al. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014;23 (10);465- 476
- Johnson A et al. Response to letter Understanding the impact of preservation methods. Ann Plast Surg. 2017 Apr 12 [Epub ahead of print].
- Brantley JN, Verla TD. Use of Placental Membranes for the Treatment of Chronic Diabetic Foot Ulcers. Advances in Wound Care. 2015 Vol 4, Iss 9: 545-559.
- Koizumi N et al. Growth factor mRNA and protein in preserved human amniotic membrane. Curr Eye Res. 2000;20(3):173-177.
- Niknejad H et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cells Mater. 2008;15:88-99.
- Parolini O et al. Concise Review: Isolation and Characterization of Cells from Human Term Placenta: Outcome of the First International Workshop on Placenta Derived Stem Cells. Stem Cells. 2008;26:300-311.
- Parry S, Strauss JF III. Premature Rupture of the Fetal Membranes. N Engl J Med 1998; 338:663-670.
- Hopkinson A. et al. Amniotic Membrane for Ocular Surface Reconstruction: Donor Variations and the Effect of Handling on TGF-β Content. Invest. Ophthalmol. Vis. Sci. 2006;47(10):4316-4322. doi: 10.1167/iovs.05-1415.
- Bourne G. The Foetal Membranes. Postgraduate Medical Journal 1962;38:193-201.
- Schultz et al. (2005). Extracellular matrix: Review of its roles in acute and chronic wounds. World Wide Wounds. 2005.
- Nakamura K et al. High, but not low, molecular weight hyaluronan prevents T-cell-mediated liver injury by reducing proinflammatory cytokines in mice. J Gastroenterol (2004) 39: 346.
- Mummert M et al. Synthesis and Surface Expression of Hyaluronan by Dendritic Cells and Its Potential Role in Antigen Presentation. J Immunol 2002; 169:4322- 4331
- Schultz, G. S. and Wysocki, A. (2009), Interactions between extracellular matrix and growth factors in wound healing. Wound Repair and Regeneration, 17: 153-162
- Sengupta S et al. Hepatocyte growth factor/scatter factor can induce angiogenesis independently of vascular endothelial growth factor. Arterioscler Thromb Vasc Biol. 2003;23(1):69-75
- Camussi G et al. Angiogenesis induced in vivo by hepatocyte growth factor is mediated by platelet-activating factor synthesis from macrophages. J Immunol February 1, 1997, 158 (3) 1302-1309
- Grant DS et al. Scatter factor induces blood vessel formation in vivo. PNAS March 1, 1993. 90 (5) 1937-1941
- Rosen EM et al. HGF/SF in angiogenesis. Ciba Found. Symp. 212 (1997) 215- 26–9.
- Conway, K et al. The molecular and clinical impact of hepatocyte growth factor, its receptor, activators, and inhibitors in wound healing. 2006. Wound Repair and Regeneration, 14: 2-10
- Nusrat et al. (1994). Hepatocyte Growth Factor/Scatter Factor Effects on Epithelia. The Journal of clinical investigation. 93. 2056-65. 10.1172/JCI117200.
- Arend WP et al. Interleukin-1 receptor antagonist: role in biology, Annu Rev Immunol. 1998;16:27-55.13.
- Eming SA et al. Inflammation in Wound Repair: Molecular and Cellular Mechanisms, Journal of Investigative Dermatology. 2007 127. 514-25
Allograft Tissue Information and Instructions for Use
This package contains human allograft tissue that is regulated as a Human Cells, and Tissues, and Cellular and Tissue-Based Product (HCTP) as defined by FDA 21 CFR Part 1271.
NuShield® is a sterile, dehydrated placental allograft processed by DCI Donor Services (DCIDS) Tissue Bank from donated amniotic-derived human tissue. DCIDS Tissue Bank is a full service not-for-profit tissue bank accredited by AATB and registered with FDA.
CAUTION: This product is restricted to sale by or on the order of a physician or properly licensed practitioner.
Donor Screening for Tissue Procurement
An appropriate blood sample from the donor is tested for relevant communicable diseases by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on live human specimens under the CLIA Laboratory Improvement Amendments (CLIA) of 1988 using, when available, FDA approved test kits. This tissue was tested for and had negative or non-reactive results for the following:
- anti-HIV-1 and anti-HIV-2
- HIV-1/HBV/HCV NAT
- Hepatitis B surface Antigen (HBsAg)
- Hepatitis B Core total antibody (anti-HBc)
- Hepatitis C antibody (anti-HCV)
- HTLV I/II
- WNV NAT
These test results, donor risk assessment questionnaire, physical examination and other available relevant donor records have been evaluated and deemed eligible for transplant by a Medical Director. Donor eligibility determination was performed by DCI Donor Services - Tissue Bank, 1714 Hayes Street, Nashville, TN 37203.
Technical quality assurance standards are rigorously maintained by DCI Donor Services – Tissue Bank (DCIDS). Tissue is processed aseptically in a controlled, clean environment. This tissue is processed using some or all of the following agents: Dulbecco’s Modified Eagle’s Medium (DMEM), vancomycin and gentamicin. Although the tissue was rinsed with sterile water or sterile saline throughout the processing procedure, traces of the medications and chemicals may remain. Final product is terminally sterilized using a validated gamma irradiation process.
- NuShield is contraindicated for use on clinically infected wounds.
- NuShield is contraindicated for surgical implantation sites with active or latent infection
Warnings & Precautions
As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted. However, this risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening criteria, laboratory testing, aseptic processing and terminal gamma irradiation of final product.
- Single patient, single use only.
- Do not sterilize or re-sterilize.
- Do not use if the package integrity has been violated, opened, or damaged, or if mishandling has caused possible damage or contamination.
- Do not use if any seal is broken or compromised.
- Return all compromised or flawed packaging to Organogenesis, Inc.
- Once opened, allografts must be used immediately or discarded.
- Do not use if expiration date has been exceeded.
- Store product at ambient temperature.
- Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician. Do not use if the tissue has not been stored according to the recommended storage instructions.
- Caution should be exercised on patients with known sensitivity or allergies to vancomycin, gentamicin, or any of the processing agents listed under the processing section of this document.
- The healthcare professional is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications or adverse reactions.
Complications and Possible Adverse Effects
Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens.
Therefore, the following complications may occur with tissue transplantation:
- Transmission of diseases of unknown etiology;
- Transmission of known infectious agents such as, viruses, bacteria and fungi;
- Immune rejection of implanted HCT/P; or
- Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration.
Report any adverse outcomes to Organogenesis, Inc immediately.
Tissue Preparation/and Use
These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgement concerning patient care. Prior to topical application to a wound or surgery, carefully follow the tissue preparation steps as described below. If desired, NuShield may be rehydrated in Lactated Ringers, Normal Saline, or other normal physiologic solution containing antibiotics of the clinician’s preference.
- Visually inspect packaging to ensure that it is intact and that its integrity has not been compromised. If the packaging is damaged, the enclosed graft may be contaminated and should not be used.
- Peel open outer heat-sealed package and drop the inner envelope packing onto the sterile field.
- Visually inspect the envelope to ensure that it is intact and that its integrity has not been compromised. If the packaging is damaged, the enclosed graft may be contaminated and should not be used.
- If no damage is detected, open the inner envelope and remove NuShield from its sterile packaging using aseptic techniques, being careful to maintain the sterility of the product. Once opened, NuShield must be used immediately or discarded. Do not return opened allografts to Organogenesis, Inc.
- The graft may be immediately applied or implanted or may be rehydrated in a sterile solution prior to application or surgical implantation. NuShield is easier to manipulate prior to rehydration.
- Determine which side of NuShield is the chorion side (to be placed in contact with the wound bed or surgical implantation site) using the T.R.U.E. method: When the middle notch is at the top, and the notched corner is to its right, then the upper side is epithelial and the side facing down is chorion.
- For all sizes, including for the 1.6cm disc that does not have notching, the foil is on the epithelial side, the side without the foil therefore is the chorion side, which should be placed in contact with the wound bed or surgical implantation site.
- Place NuShield onto the wound bed or surgical implantation site, being careful to preserve orientation of the product and ensuring that the chorion side is in contact onto the wound bed or implant site.
- Once NuShield is placed, the product may be rehydrated, as necessary, based on the characteristics of the wound or implant site.
- Anchor NuShield using preferred fixation method.
- For topical wound applications, apply a non-adherent, non-occlusive primary dressing directly over NuShield which should remain in place for up to one week.
- For topical wound applications, apply a secondary dressing specific to the wound type. NuShield may be reapplied weekly as needed.
Organogenesis, Inc. is required by 21 CFR 1271 to maintain documentation about the disposition of each tissue to enable tracking from the donor to the consignee or final disposition. Joint Commission standards require that “the organization that receives tissue provides a system that fully complies with the completion and return of tissue usage information cards requested by source facilities.”
To comply with these requirements, Organogenesis, Inc. provides an Allograft Implant Record (AIR) and preprinted labels with every graft. Record the patient information, the transplantation facility name and address, the allograft tissue identification information (using stickers) and comments regarding tissue on the AIR. Return the completed form to Organogenesis, Inc. (see address below) and retain a copy in the patient medical record. Even if the tissue has been discarded for any reason, AIR completed with the allograft identification information and reason for discard needs to be returned to Organogenesis, Inc. Storage and Handling
It is the responsibility of the user facility and user clinician to maintain allograft tissue in appropriate storage conditions prior to transplant. All dehydrated allografts must be maintained at ambient temperature prior to use. DO NOT FREEZE.
Please contact Customer Service at 1-888-432-5232 for information regarding Organogenesis, Inc. Tissue Return Policy.
Organogenesis, Inc. and DCIDS – Tissue Bank make no claims concerning the biologic or biomechanical properties of allograft tissue. All tissue has been collected, processed, stored and distributed according to nationally recognized standards and in compliance with applicable U.S. Food and Drug Administration requirements. Although efforts have been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease. Adverse outcomes potentially attributable to the tissue must be reported immediately to Organogenesis, Inc.
Dehydrated placental allograft including the amnion and chorion with the spongy layer intact.
NuShield® undergoes a proprietary process called BioLoc, which preserves the native amnion and chorion layers with the spongy layer intact,1 unlike many placental allografts on the market. The spongy layer is an abundant source of proteoglycans and glycoproteins.2,3 The BioLoc process has been optimized to provide excellent strength, flexibility, and handling characteristics, while preserving the native protein content.1 The BioLoc process allows NuShield to be stored at room temperature.
NuShield contains extracellular matrix (ECM) proteins, including collagen, laminin, and fibronectin, as well as growth factors and cytokines that are known to be important in the wound healing process.1-3 The BioLoc process preserves these important components of the native tissue.1
Unlike many other placental allografts, NuShield includes the spongy layer along with the amnion and chorion. The spongy layer provides an abundance of hydrated proteoglycans and glycoproteins, as well as a rich network of collagen.2,3
Growth Factors and Cytokines
NuShield has been shown to include the following growth factors and cytokines that are known to be important in the wound healing process.1,4
Storage and Handling
NuShield must be maintained at ambient temperature prior to patient application. DO NOT FREEZE.5 NuShield may be stored for up to 5 years at room temperature.
Multiple sizes are available for diverse applications and wound sizes.
NuShield Application Guide
Preparation of the Wound Bed
- Ensure that the wound is free of infection.
- Proper debridement of the wound should be performed and should extend to healthy, viable bleeding tissue.
- Hemostasis should be achieved and heavy exudate controlled.
- Remove NuShield from its sterile packaging using aseptic techniques, being careful to maintain the sterility of the product.
- Determine which side of NuShield is the chorion side (to be placed in contact with the wound bed) using the T.R.U.E Method.
- When the middle notch is at the top, and the notched corner is to its right, then the upper side is epithelial and the side facing down is chorion.
*Once NuShield is placed, the product may be rehydrated, as necessary, based on the characteristics of the wound. (NuShield is easier to manipulate prior to rehydration).
NuShield is processed aseptically in a controlled, clean environment. The tissue undergoes extensive donor and product screening and testing for relevant communicable diseases to minimize potential risks of disease transmisison. Final product is terminally sterilized using a validated gamma irradiation process.5
NuShield is regulated as a Human Cellular and Tissue Based Product (HCT/P) solely under Section 361 of the Public Health Service Act as defined in 21 CFR Part 1271.5
- Active or latent infection in or around the surgical implantation site.
- Sensitivity or allergies to any of the processing agents.
Warnings and Precautions
As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted. However, this risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening criteria, laboratory testing, aseptic processing and terminal gamma irradiation of final product. Single patient, single use only. Do not sterilize or re-sterilize.5
NuShield is billed using Q4160 along with CPT codes 15271-15278.
Coverage should be verified prior to treatment through our Benefit Verification Program.
NuShield may be applied as a wound covering
to a variety of partial- and full-thickness acute and chronic wounds.
Clinical Experience as a Wound Covering
NuShield has been used in wound care clinics since May 2015 and has been applied to a variety of acute and chronic wounds.1