Connectrix Trelio™
Human placental connective tissue allograft, supplied sterile and dry. Pronounced TRELL-ee-oh.
Connectrix Trelio™ is a dehydrated human placental allograft available in a myriad of sizes.
Trelio is intended only for homologous use to cover or protect, and provides an extracellular matrix to support damaged or inadequate tissue. It is applied to the surgical site and may be secured in place in a variety of ways at the discretion of the treating physician. It is intended for single patient use on a single occasion only.
The allograft is derived from voluntarily donated human tissue. All recovery, processing and distribution costs are reimbursed in accordance with the National Organ Transplant Act.
Regulatory classification
Trelio is a human tissue product for transplantation, processed and supplied in accordance with FDA requirements for Human Cellular and Tissue-based Products (HCT/P), 21 CFR Part 1271, and applicable state regulations.
How it is supplied
| Tissue | Human placental membrane |
|---|---|
| Form | Dehydrated sheet; may be trimmed dry with sterile sharp scissors |
| Sterilization | Terminally sterilized by e-beam irradiation to validated parameters |
| Packaging | Double pouch — outer foil pouch, inner Tyvek pouch, each with a peel-back heat seal |
| Storage | Clean, dry environment at room temperature, 1 °C to 45 °C. No refrigeration. Do not freeze. |
| Expiration | See package label |
| Identification | Unique serial number per allograft; peel-off tissue ID labels and an Allograft Tracking Record in every package |
| Use | Single patient, single use. Use within one hour of opening the inner pouch. Do not reuse or re-sterilize. |
| Configurations | Available sizes and reference numbers supplied on request — contact us for the current configuration list |
Bioburden control, then terminal sterilization.
Placental membrane tissue is processed under strict, quality-controlled protocols validated for bioburden control, and every graft is then terminally sterilized by e-beam irradiation. Recovery, donor eligibility determination and release are performed by an FDA-registered tissue establishment under 21 CFR Part 1271.
In the room
- Inspect before opening
Do not use if any package element is missing, tampered with or damaged, if the label or barcode is illegible, or if the expiration date has passed.
- Open the outer foil pouch
Deliver the inner Tyvek pouch to the sterile field. The outside of the outer pouch is not sterile.
- Open the inner pouch
Peel from the chevron seal and remove the allograft with forceps. Use within one hour of opening.
- Trim dry
Before hydration, cut with sterile sharp scissors to the approximate size required.
- Place and hydrate
Place the graft on the area of intended application. It may be hydrated in situ with sterile water or 0.9% saline.
- Secure
Absorbable or non-absorbable suture, tissue adhesive or another method of fixation, at the physician’s preference. The allograft may also be secured to itself.
- Record
Affix a peel-off tissue label to the patient record and the Allograft Tracking Record, and return the record to Connectrix Bio.
Every donor, tested
Donation is authorized by the mother of the newborn. Recovery is performed aseptically by licensed tissue establishments, and eligibility is determined by a tissue establishment medical director under FDA requirements and AATB standards. Each donor is tested and shown to be negative or nonreactive for:
- HIV-1 and HIV-2 antibody
- Hepatitis C virus antibody
- Hepatitis B surface antigen and core antibody (total)
- Syphilis — RPR or treponemal-specific assay
- HIV-1 / HCV / HBV nucleic acid test
- HTLV-I and HTLV-II antibody, when applicable
- West Nile virus RNA screen (PCR)
Testing is performed by an FDA-registered, CLIA-certified laboratory using test kits approved, licensed or cleared by the FDA.
Warnings
Careful donor screening, laboratory testing and tissue processing are used to minimize the risk of transmission of relevant communicable diseases. As with any processed human donor tissue, this allograft cannot be guaranteed to be free of all pathogens. Do not use on areas with active or latent infection. Use caution in immunocompromised patients. Do not reuse, reprocess or re-sterilize. Additional contraindications shall be determined by the treating physician. Read the Instructions for Use in full before every application.