Question 1

What is Vistagraft?

Accepted Answer

Vistagraft is a dehydrated human amniotic membrane allograft intended for use as a biological covering on the ocular surface. It is regulated as a human cell, tissue, and cellular and tissue-based product (HCT/P) under Section 361 of the PHS Act and 21 CFR Part 1271, for homologous use only.

Question 2

Is Vistagraft FDA-cleared or FDA-approved?

Accepted Answer

No. Vistagraft is a Section 361 HCT/P regulated under 21 CFR Part 1271 for homologous use. It is not an FDA-cleared or FDA-approved device or drug.

Question 3

How is Vistagraft stored?

Accepted Answer

Store Vistagraft at ambient temperature, 15°C to 27°C. Do not freeze. There is no cold chain to manage and no thawing or rinsing step before use. Vistagraft has a 3-year shelf life at ambient temperature.

Question 4

How is Vistagraft sterilized?

Accepted Answer

Vistagraft is terminally sterilized by Electron Beam Radiation (EBEAM) to a Sterility Assurance Level (SAL) of 10⁻⁶. It may not be re-sterilized by the end user.

Question 5

How is Vistagraft packaged and presented?

Accepted Answer

Vistagraft is supplied in a dual-pouch system — a peel-open outer pouch and a tear-notch inner pouch. The inner pouch is sterile and is presented aseptically to the sterile field. The product is for single patient use only; once the package seal is opened, the tissue must be transplanted or discarded.

Question 6

What donor screening and testing is performed?

Accepted Answer

Donors are screened through medical and social history, and donor specimens undergo serological and nucleic-acid (NAT) infectious-disease testing by an FDA-registered, CLIA-certified laboratory (42 CFR Part 493), with nonreactive/negative results. A Medical Director makes the donor eligibility determination. See the Quality & Compliance page for the full testing panel.

Question 7

Are there any contraindications?

Accepted Answer

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.

Question 8

What sizes and configurations are available?

Accepted Answer

Vistagraft is available in two disc sizes — 8 mm and 12 mm dehydrated amniotic membrane discs — with a 3-year shelf life at ambient temperature. Please request current product information for the configurations available to your practice.

Question 9

How do I order Vistagraft?

Accepted Answer

Create your account on the Vistagraft ordering portal — about a five-minute, one-time setup — to see clear, upfront pricing with volume discounts and order online, yourself or through your rep. You can place orders, set up monthly subscriptions, and reorder in seconds, with same-day shipping on most orders. Prefer to talk first? Request pricing through the contact form and a rep will follow up.

Question 10

Who distributes Vistagraft?

Accepted Answer

Vistagraft is distributed by Blue River Medical, Inc. For pricing, product information, or ordering support, please contact Blue River Medical.

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