Regulatory Information
Vendaje products are processed from human tissue according to FDA Current Good Tissue Processing (CGTP) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act.
Vendaje products are minimally manipulated, dehydrated, non-viable cellular amniotic membrane allografts that contain multiple extracellular matrix proteins, growth factors, cytokines and other specialty proteins present in amniotic tissue to provide a barrier membrane that enhances healing.
Vendaje products may be stored at ambient conditions for up to 5 years. With a variety of sizes available, Vendaje offers size-appropriate grafts to minimize waste.
Our Amniotic Membrane Allograft:
- Enhances Healing
- Modulates Inflammation
- Reduces Scar Tissue Formation
Harvesting
The amniotic membrane products are harvested from live, healthy US based donors. These donors are consented and undergo a scheduled c-section procedure and have agreed to donate their amniotic fluid and placental tissue.
SCREENING & TESTING
All donated tissues are determined to be suitable for transplantation by a licensed physician, Medical Director of the Tissue Bank. Prior to processing, serological and microbial testing is performed.
Communicable disease testing is performed by a laboratory that is registered with FDA and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or equivalent requirements.
- Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
- Nucleic Acid Test for HIV-1 RNA
- Hepatitis B Virus (HBV) Surface Antigen
- Hepatitis B Virus (HBV) Core Antibody (Total)
- Nucleic Acid Test for HBV RNA
- Antibody to Hepatitis C Virus (HCV)
- Nucleic Acid Test for HCV RNA
- Antibody to Human T Cell Lymphotrophic Virus 1 & 2 (HTLV 1 & 2)
- Rapid Plasma Reagin (RPR) Screen, or Syphilis Treponemal Specific (STS) Test