VENDAJE™

Dehydrated human amniotic membrane allograft

VENDAJE™ allografts are easy-to-apply dehydrated amniotic membranes that adhere without the need for glue or sutures. Fibrin-elastin bonds are quickly formed at the wound-dressing interface, which protects nerve endings, provides pain relief, and provides bioactive scaffolding for consistent and non-fibrotic tissue regeneration. The amnion membrane is a selective barrier that inhibits pathogen transmission and prevents excessive moisture loss, reducing the rate of infections and increasing healing. In addition, the presence of hyaluronic acid in the amniotic membrane promotes non-fibrotic healing, which minimizes the development of scar tissue and improves the integrity of the scar.

Placentally-derived VENDAJE™ provides the same benefits of a fresh allograft in a high tensile strength, single amniotic membrane layer. The dehydrated amniotic membrane is a 150-micron thick lamina that contains the full spectrum of bioactive growth factors, cytokines, and ECM scaffolding and signaling molecules. VENDAJE™ allografts are aseptically processed and terminally sterilized, making them suitable for topical and intra-operative applications, and they have an ambient shelf life of 2-years.

VENDAJE™ is available in 1x1cm, 2x2cm, 2x4cm, 4x4cm, 4x6cm, 4x8cm, and 6x6cm sizes.

Amniotic membrane allografts have been used for more than a century to treat acute and chronic conditions, and new applications continue to be discovered1. The amniotic membrane is the inner lining of the placenta, and it is a packed with nutrients, growth factors, and immunomodulatory cytokines that support tissue development. These properties make the amniotic membrane a powerful regenerative medicine, and VENDAJE™ dehydrated human amniotic membrane allografts are suitable for a range of therapeutic applications.

The amniotic membrane is the inner layer of the placenta, and it’s composed of epithelial and mesenchymal stem cells that have potent immunosuppressive and regenerative properties. These cells are normally responsible for maintaining the fetal environment, meaning they need to promote controlled cellular growth and differentiation without eliciting an immune response.

Immunosuppression is achieved via the secretion of a broad array of paracrine-acting cytokines like interleukin 4 (IL-4) and prostaglandin E2 (PGE2), which suppress activation and proliferation of CD4+ and CD8+ T cells and B cells, while promoting anti-inflammatory M2 macrophage activation and blocking the differentiation of monocytes to antigen-presenting dendritic cells2-3. Amniotic tissues also inhibit the release of pro-inflammatory IFN-γ from cytotoxic natural killer (NK) cells4.
To promote tissue development, amniotic epithelial and mesenchymal cells secrete an array of growth factors including epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), keratinocyte growth factor (KGF), transforming growth factors alpha and beta (TGF‐α and TGF‐β), nerve growth factor (NGF), myriad interleukins, and tissue inhibitors of metalloproteinases (TIMPs)5. They also produce bioactive scaffolding compounds like laminin, proteoglycans, hyaluronic acid, and fibronectin, which are crucial for stable tissue regeneration during wound healing.

Studies into the efficacy of dehydrated amniotic membrane allografts are consistently impressive. From intra-operative applications like spinal fusion6 and tendon repair7 to treatment of diabetic foot ulcers8, amniotic allografts have been shown to significantly improve healing. They have also been used to increase peripheral nerve regeneration and improve peripheral neuropathy9, and dermatologists are using them to give clients a more youthful appearance10.

VENDAJE™ Key Points

  • Bonds with wounds by forming fibrin-elastin at the wound-dressing interface
  • Acts as a vapor barrier, preventing fluid loss from excessive evaporation from the wound surface
  • Designed for application directly to acute and chronic wounds
  • Adheres naturally via hydrostatic tension
  • No blood typing or donor matching required
  • No orientation issues, can be applied on either side
  • Contains full spectrum of growth factors
  • Biocompatible scaffold with extracellular matrix
  • No Immune Rejection
  • Moderate levels of fibronectin and laminin
  • Anti-fibrotic and anti-adhesion barrier
  • High tensile strength

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References
1. Silini, A.R., et al., The Long Path of Human Placenta, and Its Derivatives, in Regenerative Medicine. Frontiers in bioengineering and biotechnology, 2015. 3: p. 162-162.
2. Li, H., et al., Immunosuppressive factors secreted by human amniotic epithelial cells. Invest Ophthalmol Vis Sci, 2005. 46(3): p. 900-7.
3. Banas, R., et al., Amnion-derived multipotent progenitor cells inhibit blood monocyte differentiation into mature dendritic cells. Cell Transplant, 2014. 23(9): p. 1111-25.
4. Chatterjee, D., et al., Role of gamma-secretase in human umbilical-cord derived mesenchymal stem cell mediated suppression of NK cell cytotoxicity. Cell Commun Signal, 2014. 12: p. 63.
5. Koob, T.J., et al., Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater, 2014. 102(6): p. 1353-62.
6. Nunley, P.D., et al., Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion. Int J Spine Surg, 2016. 10: p. 12.
7. Ang, J., C.D. Liou, and H.P. Schneider, The Role of Placental Membrane Allografts in the Surgical Treatment of Tendinopathies. Clin Podiatr Med Surg, 2018. 35(3): p. 311-321.
8. Haugh, A.M., et al., Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis. Plastic and reconstructive surgery. Global open, 2017. 5(4): p. e1302-e1302.
9. Li, Y., et al., Amniotic mesenchymal stem cells display neurovascular tropism and aid in the recovery of injured peripheral nerves. J Cell Mol Med, 2014. 18(6): p. 1028-34.
10. Davis, A. and A. Augenstein, Amniotic Allograft Implantation for Midface Aging Correction: A Retrospective Comparative Study with Platelet-Rich Plasma. Aesthetic Plast Surg, 2019. 43(5): p. 1345-1352.