About Vendaje
VENDAJE IS A HUMAN CONNECTIVE TISSUE MATRIX COMPRISED OF AMNIOTIC 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 is intended for homologous use as a protective covering.
Easy to Use—Easy to Store
USING VENDAJE
THE INTRINSIC PROPERTIES OF DEHYDRATED HUMAN AMNIOTIC MEMBRANE (DHAM)
make VENDAJE a versatile option for a wide variety of topical covering applications.
Properties of Dehydrated Human Amniotic Membrane
Helps prevent local contamination
Demonstrates antimicrobial properties
Helps prevent moisture loss
Provides a 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 BEHIND VENDAJE
A NATURAL FOUNDATION FOR 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.
Dehydrated human amniotic membrane (DHAM) is now widely used across clinical specialties as a covering for chronic wounds, burns, incisions and other treatment areas where a protective barrier is needed.
Structure of the Amniotic Membrane
The amniotic membrane forms the innermost layer of the human placenta and acts as a protective barrier for the developing fetus.
A LOOK INSIDE VENDAJE
Natural Amniotic Components Retained in VENDAJE
VENDAJE 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 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
– Proteoglycans
The ECM of amniotic membrane provides mechanical protection and functional support for cell attachment, proliferation, and migration.
HISTOLOGY OF VENDAJE
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 allograft: 6,201,288 picograms/cm2
Growth factors:
– Epidermal growth factor (EGF)
– Vascular endothelial growth factor (VEGF)
– Basic fibroblast growth factor (bFGF)
– Keratinocyte growth factor (KGF)
* This is not a comprehensive list of the substances found within a VENDAJE 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 allografts are available in a wide range of sizes and shapes for maximum versatility.
| Product SKU | Size |
|---|---|
| 200-004-0202-001 | 2 x 2 cm |
| 200-008-0204-001 | 2 x 4 cm |
| 200-016-0404-001 | 4 x 4 cm |
| 200-024-0406-001 | 4 x 6 cm |
| 200-032-0408-001 | 4 x 8 cm |
| 200-036-0606-001 | 6 x 6 cm |
| 200-080-0810-001 | 8 x 10 cm |
| 200-100-1010-001 | 10 x 10 cm |
| 200-150-1015-001 | 10 x 15 cm |
| 200-200-1020-001 | 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? Contact our team of experienced professionals:
Email: reimbursement@biostemtech.com
Reimbursement Hotline (Toll-Free): 1-888-948-BSEM (2736)
Billing Code Support*
*Facilities should select the most appropriate revenue code based on the services provided and internal accounting policies. The information contained herein is not intended as coding advice and is provided for informational purposes only. It represents no statement, promise or guarantee by BioStem Technologies concerning levels of reimbursement, payment, eligibility, charges or that these policies and codes will be appropriate for specific services or products provided or that reimbursement will be made. It is always the providers’ responsibility to determine and submit appropriate codes, charges, modifiers and bills for the services that were rendered. BioStem Technologies recommends that you consult your local CMS MAC or other applicable payor organization with regard to specific reimbursement policies, coverage, documentation and payment.
Reimbursement Guide for Private OfficesCOMPARE 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 is intended for homologous use as a covering and barrier for human tissue. Refer to VENDAJE Instructions for Use for information on safety, usage, and storage.
- VENDAJE 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.
- 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.
- 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.
- Wassmer C-H. Berishvili E. Immunomodulatory Properties of Amniotic Membrane Derivatives and Their Potential in Regenerative Medicine. Curr. Diab. Rep. 2020;20(31).
- 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
