Connectrix Nelva™
Dehydrated human placental connective tissue allograft, supplied sterile as a membrane disc or discs.
Connectrix Nelva™ is a dehydrated human placental connective tissue allograft prepared from decellularized placental membrane. Each unit contains a membrane disc or discs, supplied in a sterile screw-cap bottle that is itself packaged in a pouch and opened on the sterile field.
Nelva is intended only for homologous use to replace or supplement damaged or inadequate connective tissue, and may be used for that purpose in a variety of surgical applications, as determined by the treating physician. Nelva 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
Nelva is a human tissue product for transplantation, regulated as a 361 HCT/P under 21 CFR Part 1271 and intended for homologous use. It is processed and supplied in accordance with FDA requirements for Human Cellular and Tissue-based Products, AATB standards and applicable state regulations. The complete intended-use statement is in the Instructions for Use.
How it is supplied
| Tissue | Decellularized human placental membrane |
|---|---|
| Form | Dehydrated membrane disc or discs |
| Container | Sterile screw-cap bottle, sterile inside and out, within a pouch |
| Sterilization | Terminally sterilized by e-beam irradiation |
| Storage | See package label and Instructions for Use |
| Expiration | See package label |
| Identification | Unique allograft identification number; tracking record returned to Connectrix Bio |
| Use | Single patient, single use. Do not reuse or re-sterilize. |
| Configurations | Available sizes and reference numbers supplied on request — contact us for the current configuration list |
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 pouch
Deliver the sterile bottle to the sterile field using standard aseptic technique.
- Open the bottle on the field
Remove the cap and retrieve the membrane disc or discs.
- Hydrate or moisten
Prepare for placement as the physician prefers.
- Place
Place the allograft at the surgical site.
- Record
Enter the unique allograft identification number in the patient record and return the tracking record to Connectrix Bio.
Summary only. Follow the Instructions for Use supplied in every package.
Every donor, screened and tested
Donation is authorized by the mother of the newborn. Recovery is performed aseptically by licensed tissue establishments, and donor eligibility is determined by a tissue establishment medical director under FDA requirements and AATB standards. Screening includes:
- Review of the donor medical and social history
- Physical assessment
- Serological screening for relevant communicable diseases
- Nucleic acid testing
- Tissue collection microbiology
The complete donor test panel is listed in the Instructions for Use. Testing is performed by an FDA-registered, CLIA-certified laboratory.
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 reuse or re-sterilize. Do not subject to additional sterilization procedures. Contraindications shall be determined by the treating physician. Read the Instructions for Use in full before every application.