barrera™

by

DUAL LAYER AMNIOTIC MEMBRANE ALLOGRAFT

Tissue Characteristics

Dual-layer amniotic membrane.

Intended for homologous use only. Acts as a wound cover, that is a natural bandage shielding wounds from its external environment.

Proprietary processing of the tissue ensures that the natural structure and relevant characteristics are preserved.

Dehydrated, packaged, and terminally sterilized with a 2-year shelf life. Stored at ambient temperature.

Applications

Wound Covering

Diabetic Foot Ulcer Covering

Venous Stasis Ulcer Covering

Burn Covering

Tissue Processing – Amniotic Membrane Barrier

The amniotic membrane for barrera™ is sourced from healthy deliveries of placental tissue with maternal consent.

Processed using minimally manipulated amniotic membrane in a dual layer composition to retain the amniotic membrane’s original relevant characteristics of the placental extracellular matrix (ECM).

The amniotic membrane’s key structural components, specifically the epithelium layer, as well as the basement layer of the placental tissue, are retained to allow the membrane its utility to serve as a barrier.

May adhere to the underlying wound surface as a cover protecting wounds and may help prevent formation of dead space on wounds.1,2

May prevent infiltration and adhesion of microorganisms to wounds.1,2

1 Malhotra C, Jain AK. Human amniotic membrane transplantation: Different modalities of its use in ophthalmology. World J Transplant. 2014 Jun 24;4(2):111-21. doi: 10.5500/wjt.v4.i2.111. PMID: 25032100; PMCID: PMC4094946.

2 Gupta A, Kedige SD, Jain K. Amnion and Chorion Membranes: Potential Stem Cell Reservoir with Wide Applications in Periodontics. Int J Biomater. 2015;2015:274082. doi: 10.1155/2015/274082. Epub 2015 Dec 6. PMID: 26770199; PMCID: PMC4684856.

Disclaimer: Please consult your doctor to see if tissue allograft is right for you. No medical advice has been offered herein. None of the statements in this brochure have been evaluated by the FDA.

Amniotic tissue allografts are not intended to diagnose, treat, cure or prevent any disease.

The FDA’s Tissue Reference Group (TRG) has determined that barrera™ appears to meet all of the criteria for regulation solely under section 361 of the Public Health Service Act and the regulations in 21 CFR part 1271 governing Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/Ps).

Additional Resources:

Contact Us

Contact Us