Know exactly what you're placing.
Amniotic membrane is the innermost layer of the placental membranes. This page describes the tissue and the controlled path Vistagraft follows from donation to distribution. Clinical statements are drawn from, and attributed to, the peer-reviewed literature.
The innermost layer of the placental membranes.
Amniotic membrane is a thin, translucent tissue that forms the innermost layer of the fetal membranes. In the peer-reviewed literature it is described as comprising three layers — an epithelium, a basement membrane, and an avascular stroma — and has a long history of described use in ophthalmic surgery as an ocular surface covering, a basement-membrane substitute, and a temporary graft.
Three described layers
Epithelial layer
A single layer of epithelial cells on the surface of the membrane, resting on the basement membrane.
Basement membrane
One of the thickest basement membranes in the body, described in the literature as a substrate for epithelial cells.
Stroma
An avascular connective-tissue stroma, described as comprising a compact layer, a fibroblast layer, and an outer spongy layer.
Illustrative representation of the described layers of amniotic membrane. Not to scale.
A controlled, documented tissue chain.
Every Vistagraft allograft follows a defined sequence of recovery, screening, testing, eligibility review, processing, terminal sterilization, and packaging — with traceability maintained throughout.
- 01
Consented donation & recovery
Tissue is recovered from screened donors following consent or authorization, using aseptic technique in a controlled environment.
- 02
Donor screening
Donor eligibility is assessed through medical and social history and review of relevant records.
- 03
Infectious-disease testing
Serological and NAT testing is performed by an FDA-registered, CLIA-certified laboratory (42 CFR Part 493).
- 04
Medical Director review
A Medical Director reviews screening and test results to make the donor eligibility determination.
- 05
Aseptic processing
Eligible tissue is processed into a dehydrated allograft under controlled, aseptic conditions within a defined quality system.
- 06
Terminal sterilization
The packaged allograft is terminally sterilized by Electron Beam Radiation (EBEAM) to a Sterility Assurance Level of 10⁻⁶.
- 07
Packaging & traceability
Dual-pouch packaging and a tissue traceability (TTR) record support lot traceability from donation to distribution.
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Grounded in the peer-reviewed literature
Literature, not product claims
Dua HS, Gomes JAP, King AJ, Maharajan VS. The amniotic membrane in ophthalmology. Surv Ophthalmol. 2004;49(1):51–77.
Malhotra C, Jain AK. Human amniotic membrane transplantation: different modalities of its use in ophthalmology. World J Transplant. 2014;4(2):111–121.
Meller D, Pauklin M, Thomasen H, Westekemper H, Steuhl KP. Amniotic membrane transplantation in the human eye. Dtsch Arztebl Int. 2011;108(14):243–248.
Bibliography compiled from PubMed-indexed, peer-reviewed literature. Citations describe amniotic membrane generally and do not constitute claims regarding Vistagraft.
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