ABOUT VENDAJE AC
VENDAJE AC IS A HUMAN CONNECTIVE TISSUE MATRIX COMPRISED OF DEHYDRATED AMNIOTIC/CHORIONIC TISSUE
BioRetain®-the science of letting nature do its work
Six steps work together to preserve the natural integrity of amniotic tissue:
Minimally damaging
Disinfection
The membrane is submerged in an effective bactericidal, tuberculocidal, fungicidal and virucidal solution to eliminate pathogens
Manual hematopoietic
Reduction
Blood and blood-producing components are removed by hand without scraping or scrubbing to preserve membrane structure
Cold isotonic
Cleansing
A series of washes in clean, low-temperature, pH-balanced solution with gentle stirring remove remaining debris while minimizing tissue and growth factor breakdown
Gentle and gradual
Dehydration
Slow drying of the membrane using physiological temperature preserves tissue structure and natural growth factors, preventing damage from freezing or high temperatures
Precise cutting die
Placement
Precise, manual placement of cutting dies helps ensure optimal tissue quality for each individual allograft
Low-dose E-beam terminal
Sterilization
Grafts are individually packed and terminally sterilized to an assurance level of 10-6 via electron beam*, avoiding harmful biproducts or excessive irradiation associated with other methods
*Our sterilization assurance level (SAL) is generally accepted for pharmacopeial sterilization procedures, with a probability of not more than one viable microorganism per one million sterilized items of the final product.
VENDAJE AC is intended for homologous use as a protective covering.
Easy to Use—Easy to Store
USING VENDAJE AC
THANKS TO A HIGHER TENSILE STRENGTH AND THICKNESS, AS WELL AS THE GREATER QUANTITY OF NATURAL GROWTH FACTORS
resulting from the inclusion of the intermediate and chorion layers, VENDAJE AC is a more robust covering than a single-layer allograft.
Clinicians performing major surgery, as well as those treating complex wounds and severe burns, have explored the use of DHACM as a covering for areas in need of enhanced tissue scaffolding and protection.
Properties of Dehydrated Human Amniotic/Chorionic Membrane
Helps prevent local contamination
Demonstrates antimicrobial properties
Helps prevent moisture loss
Provides a robust scaffold for tissue healing
Contains a range of growth factors
Contains anti-inflammatory cytokines
Amniotic tissue is a natural reservoir of growth factors, extracellular matrix (ECM) components, and anti-inflammatory cytokines which are known to support the body’s natural healing processes.
THE SCIENCE OF PERINATAL TISSUE ALLOGRAFTS
MULTI-LAYERED SUPPORT FOR NATURAL HEALING
Placentally-derived human amniotic membrane (AM) is a potent source of pro-healing growth factors and anti-inflammatory cytokines and has successfully been used in regenerative medicine for over a century. Early users of AM for wounds and post-surgical applications noted how the membrane seemed to disappear and integrate with the patient’s own tissue without a host reaction. This apparent immune neutrality is a result of mechanisms that suppress and modulate the immune system.
The use of AM was initially limited due to storage challenges associated with use of the fresh tissue. Modern processing methods – including dehydration – have delivered options that have longer shelf lives, can be stored at ambient temperatures, and can be terminally sterilized. In recent decades, advances in our understanding of placental tissues and improved processing abilities have resulted in the creation of dehydrated combined amniotic/chorionic membrane (DHACM) products.
DHACM is now widely used where clinicians believe a thicker covering, richer in pro-healing factors, is needed. Post-surgical, trauma, burn, and complex wound applications for DHACM have been well-documented in the literature, and new applications continue to be explored.
The Combined Amniotic and Chorionic Membranes
The combination of amnion and chorion is thicker and higher in tensile strength than allografts containing amnion alone. It is also richer and more varied in growth factors as well thanks to the higher quantity of growth factors present in the chorion layer.
A LOOK INSIDE VENDAJE AC
Why Retain the Intermediate Layer?
Unlike some other DHACM products, VENDAJE AC also preserves the intermediate layer (IL) between the amnion and chorion. The intermediate layer has its own reserve of regulatory and signaling components, including chemokines, growth factors, interleukins, and protease inhibitors.
Natural Amniotic and Chorionic Components Retained in VENDAJE AC
VENDAJE AC allografts are prepared using our proprietary BioRetain® process, which was designed to help preserve the natural ECM components, anti-inflammatory cytokines, and endogenous growth factors within fresh tissue.
The following substances were isolated within VENDAJE AC allografts (n=6)*:
Anti-inflammatory cytokines:
– Interleukin (IL) 10
IL-10 helps suppress the pro-inflammatory milieu and modulate immunity through a variety of pathways.
– IL-1 receptor antagonist
This substance naturally inhibits pro-inflammatory effects of IL-1.
Extracellular matrix (ECM) components:
– Collagens I, III, IV, V, and VI
– Elastin
– Laminin
– Fibronectin
The ECM of both the amniotic and chorionic membranes provides mechanical protection and functional support for cell attachment, proliferation, and migration.
HISTOLOGY OF VENDAJE AC
Hyaluronic acid (HA):
HA suppresses the expression of TGF-β1, β2, and β3, as well as TGF-receptor expression, providing an anti-fibrogenic effect.
Average HA concentration in a VENDAJE AC allograft: 48,355,062 picograms/cm2
—nearly 8 times higher than our single-layer allograft
Growth factors:
– Epidermal growth factor (EGF)
– Vascular endothelial growth factor (VEGF)
– Basic fibroblast growth factor (bFGF)
– Keratinocyte growth factor (KGF)
The chorionic layer provides a significantly higher amount of growth factors than the amniotic layer, with the exception of EGF.
* This is not a comprehensive list of the substances found within a VENDAJE AC allograft.
ORDERING INFORMATION
Contact our product experts for more information or to place an order:
Product Hotline:
Local: 954-380-8342
Toll-Free: 1-888-948-BSEM (2736)
Email Inquiries:
orders@biostemtech.com
VENDAJE AC allografts are available in a wide range of sizes and shapes for maximum versatility.
| Product SKU | Size |
|---|---|
| 300-004-0202-001 | 2 x 2 cm |
| 300-008-0204-001 | 2 x 4 cm |
| 300-016-0404-001 | 4 x 4 cm |
| 300-024-0406-001 | 4 x 6 cm |
| 300-032-0408-001 | 4 x 8 cm |
| 300-036-0606-001 | 6 x 6 cm |
| 300-080-0810-001 | 8 x 10 cm |
| 300-100-1010-001 | 10 x 10 cm |
| 300-150-1015-001 | 10 x 15 cm |
| 300-200-1020-001 | 10 x 20 cm |
CarePartner Program
BioStem’s CarePartner Program is one way we show our dedication to supporting providers through every aspect of using our products. Our team is committed to facilitating the best possible customer experience and answering your questions about the coding and reimbursement process.
Have questions or need assistance with reimbursement for VENDAJE AC? Contact our team of experienced professionals:
Email: reimbursement@biostemtech.com
Reimbursement Hotline (Toll-Free):
1-888-948-BSEM (2736)
COMPARE PRODUCTS
The VENDAJE family includes VENDAJE, VENDAJE AC, and VENDAJE OPTIC.
Our amnion-layer-only allograft, available in a wide range of sizes for maximum versatility
Our thickest allograft, containing both the amnion and chorion layer, available in a range of sizes
Our thinnest and most lightweight amnion layer allograft intended for ophthalmic applications
VENDAJE AC is intended for homologous use as a covering and barrier for human tissue. Refer to VENDAJE AC Instructions for Use for information on safety, usage, and storage.
- VENDAJE AC Instructions for Use
- Data on File
- Tenehaus M. The Use of Dehydrated Human Amnion/Chorion Membranes in the Treatment of Burns and Complex Wounds. Ann Plast Surg. 2017;78: S11–S13.
- Silini AR, Cargnoni A, Magatti M, Pianta S and Parolini O (2015) The long path of human placenta, and its derivatives, in regenerative medicine. Front. Bioeng Biotechnol. 2015;3:162.
- Lei et al. Priddy LB, Lim JJ, et al. Identification of Extracellular Matrix Components and Biological Factors in Micronized Dehydrated Human Amnion/Chorion Membrane. Adv Wound Care. 2016;6(2):43-53.
- Ramuta TZ, Šket T, Erjavec MS, Kreft ME. Antimicrobial Activity of Human Fetal Membranes: From Biological Function to Clinical Use. Front Bioeng Biotechnol. 2021;9:691522.
- Heckmann N, Auran R, Mirzayan R. Application of Amniotic Tissue in Orthopedic Surgery. Am J Orthoped. 2016;45(7):E421-E425.
- Niknejad H, Peirovi H, Jorjani M et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur. Cells Mater. 2008;15(15):88-99.
- Oesman I, Dhamar Hutami W. Gamma-treated placental amniotic membrane allograft as the adjuvant treatment of unresponsive diabetic ulcer of the foot. Int J Surg Case Rep. 2020;66:313-318.
- Wassmer C-H. Berishvili E. Immunomodulatory Properties of Amniotic Membrane Derivatives and Their Potential in Regenerative Medicine. Curr. Diab. Rep. 2020;20(31).
- Caporusso J, Abdo R, Karr J, Smith M, Anaim A. Clinical experience using a dehydrated amnion/chorion membrane construct for the management of wounds. Wounds. 2019;31(4 Suppl):S19-S27.
- Moore MC, Bonvallet PP, Damaraju SM, et al. Biological characterization of dehydrated amniotic membrane allograft: Mechanisms of action and implications for wound care. J Biomed Mater Res. 2020;1–8.
- Roy, A, Griffiths, S. Intermediate layer contribution in placental membrane allografts. J Tissue Eng Regen Med. 2020;14:1126– 1135.
- Chatterjee P, Chiasson VL, Bounds KR, Mitchell BM. Regulation of the anti-inflammatory cytokines interleukin-4 and interleukin-10 during pregnancy. Front Immunol. 2014;5(23).
- Moreno SE, Massee M, Koob TJ. Dehydrated Human Amniotic Membrane Inhibits Myofibroblast Contraction through the Regulation of the TGFb‒SMAD Pathway In Vitro. JID Innov. 2021;1:100020
