Quality you can point to.
Vistagraft is regulated as a Section 361 HCT/P under 21 CFR Part 1271 for homologous use. Donor eligibility, infectious-disease testing, aseptic processing, terminal sterilization, and traceability are documented throughout the tissue chain.
361 HCT/P
21 CFR Part 1271
Homologous use
Covering of the ocular surface
EBEAM · 10⁻⁶
Terminal sterilization (SAL)
Single patient use
No re-sterilization by end user
A Section 361 HCT/P for homologous use.
Serving as a covering and offering protection from the surrounding environment are basic functions of amniotic membrane. Consistent with this, Vistagraft is intended solely for homologous use as a covering on the ocular surface. It is regulated under Section 361 of the PHS Act and 21 CFR Part 1271 and is not an FDA-cleared or FDA-approved device or drug.
Regulatory status
Controls across the tissue chain
Donor eligibility & screening
Donors are screened through medical and social history and review of relevant records. Donor eligibility is determined in accordance with 21 CFR Part 1271, Subpart C.
Medical Director determination
A Medical Director reviews donor screening and laboratory results and makes the donor eligibility (suitability) determination before release.
Infectious-disease testing
Serological and nucleic-acid (NAT) testing is performed by an FDA-registered, CLIA-certified laboratory (42 CFR Part 493). All results are nonreactive/negative.
Aseptic processing & sterilization
Tissue is processed into a dehydrated allograft under controlled, aseptic conditions, then terminally sterilized by EBEAM to a Sterility Assurance Level of 10⁻⁶.
Traceability (TTR)
A tissue traceability (TTR) record supports lot traceability from donation to the point of distribution, consistent with 21 CFR Part 1271 record-keeping.
Single patient use
For single patient use only. The graft may not be re-sterilized by the end user. Once the package seal is opened, the tissue must be transplanted or discarded.
No known contraindications
There are no known contraindications for use of this product. Refer to the complete Instructions For Use for warnings, precautions, and full directions for use.
Infectious-disease testing
Donor specimens are tested by an FDA-registered, CLIA-certified laboratory (42 CFR Part 493). The markers below are tested with nonreactive/negative results.
| Marker | Result |
|---|---|
| HIV-1/2 plus O Antibody | Nonreactive / Negative |
| HIV-1 NAT | Nonreactive / Negative |
| Hepatitis B Surface Antigen (HBsAg) | Nonreactive / Negative |
| Hepatitis B Core Antibody (HBcAb) | Nonreactive / Negative |
| Hepatitis B NAT (HBV NAT)if applicable | Nonreactive / Negative |
| Hepatitis C Antibody (HCV Ab) | Nonreactive / Negative |
| Hepatitis C NAT (HCV NAT) | Nonreactive / Negative |
| Treponema pallidum (Syphilis)IgG & IgM, with treponemal confirmatory rule | Nonreactive / Negative |
| HTLV-I/II Antibody | Nonreactive / Negative |
| West Nile Virus NAT (WNV NAT) | Nonreactive / Negative |
Non-routine screening
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Registered and accredited.
Vistagraft tissue is recovered and processed by a tissue establishment that is registered with the U.S. FDA and accredited by the American Association of Tissue Banks (AATB).
FDA registered
Tissue establishment registered with the U.S. FDA.
AATB accredited
Accredited by the American Association of Tissue Banks.
Returns & Return Authorization (RA)
Returns require prior Return Authorization (RA). Because this is a terminally sterilized, single-patient-use tissue allograft, returns are subject to product-specific conditions. Contact Blue River Medical to request an RA before returning any product.
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