AmnioClear TN is an allograft membrane tissue comprised of human amniotic and chorionic tissue, the innermost layers of placental tissue. AmnioClear TN is designed specifically for use as a tendon and nerve wrap during surgery of the extremities and is processed by a licensed processor of human tissues.
What is the product made of?
AmnioClear TN is comprised of human amniotic and chorionic tissue. The amniotic tissue, which lines the inner most portion of the placenta, consists of a single layer of epithelium cells, a basement membrane, and a stromal layer. The stromal layer can be further divided into an acellular compact layer, a fibroblast layer, and a spongy layer. The chorionic tissue is comprised of a thin reticular layer, a basement membrane and nonbioactive trophoblasts. Most of the biological activity of AmnioClear TN comes from the amniotic tissue layer. The chorionic tissue is added to increase the thickness and strength of the allograft.
What is the source of the material?
The tissue used to make AmnioClear TN is donated by birth mothers following a live birth by cesarean section.
Does the product have FDA clearance?
Since AmnioClear TN is considered an allograft, it is regulated solely under section 361 of the PHS Act because it meets all of the following criteria:
- It is minimally manipulated
- It is intended for homologous use
- It does not involve any combination with a drug or a device, except sterilizing, preserving, etc...
- It does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function.
What are AmnioClear TN indications for use?
Surgeons use amniotic materials to reduce inflammation and prevent scarring. AmnioClear TN is an allograft membrane designed to be use to protect tendons and nerves following tendon and nerve repair surgery of the extremities.
What are the available sizes for AmnioClear TN?
AmnioClear TN is available as a 4 cm x 2 cm membrane patch which can be used as supplied or cut to the appropriate size during surgery. Instructions for cutting AmnioClear TN to the desired size are included in the Instructions for Use which accompany the product.
What tests are done to insure it is safe from infectious diseases?
All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease. AmnioClear TN allografts are procured and processed according to standards established by the American Association of Tissue Banks (AATB) and the United States Food & Drug Administration (FDA). All tissues are recovered under full informed consent of the donors (represented by the mothers of the newborn children). The donors have consented to transfer of the allografts to third parties. A thorough medical and social history of the donor is also obtained, including detailed family history. The donor is screened for:
Each patch of AmnioClear is rigorously screened by a CLIA-certified lab using the following tests:
- HIV-1&2 Antibody
- HIV Type 1 Nucleic Acid Test (NAT)
- HTLV-1&2 Antibody
- Serologic Test for Syphilis
- CMV Total Antibody
- Hepatitis B Core Antibody
- Hepatitis B Surface Antigen
- Hepatitis C Antibody
- Hepatitis C Virus Nucleic Acid Test (NAT)
All tests results are reviewed prior to the release of the tissue. Only tissue from donors with acceptable test results, according to the standards of Surgical Biologics, as well as the standards of all state and federal regulatory bodies, are released.
The infectious disease test results, together with the consent documents, donor medical history and behavior risk assessment according to current public health services guidelines, physical assessment, available relevant medical records, as well as information from other sources or records which may pertain to donor suitability, along with tissue procurement test results, have been evaluated and are sufficient to indicate that the donor suitability criteria current at this time of tissue recovery have been met.
The names and addresses of the testing laboratories, the listing and interpretation of all required infectious disease tests, a listing of the documents reviewed as part of the relevant medical records, and the name of the person or establishment determining the suitability of this allograft are on file and available upon request.
How does the product work?
AmnioClear TN works as a biologic barrier to protect tendons and nerves. When used as a wrap it acts as a physical barrier to protect tendons and nerves while also having biological properties to aid in wound healing. Instructions for applying AmnioClear TN are included in the Instructions for Use which accompany the product. Unlike collagen-based dressings which are biological inert, amniotic membrane tissue has biologic properties which may be advantageous to its use for tendon repair surgery. This includes anti-fibrosis, antiscarring, anti-inflammatory, and anti-microbial, properties in addition to low immunogenicity. Studies have shown that amniotic membrane reduces scar formation by down-regulating transforming growth factor (TGF)-beta and its receptor expression on fibroblasts. Since fibroblasts require TGF-beta to be activated, this downregulation results in a reduction in fibroblast activity and fibrosis formation.
Several studies have also shown that amniotic membrane tissue has anti-microbial properties as a result of its ability to produce beta-defensins. beta-defensins are anti-microbial peptides which specifically help epithelial surfaces resist microbial colonization. Amniotic membrane tissue also produces secretory leukocyte proteinase inhibitor (SLPI) and elafin. In addition to their anti-inflammatory properties, elafin and SLPI both have antimicrobial actions and act as components of the immune system to provide protection from infection. Other studies have also reported that amniotic membrane tissue has anti-inflammatory properties as a result of its ability to markedly suppress the expression of the potent the pro-inflammatory cytokines, IL-1alpha and IL-1beta.