Amnion Allografts (Commercial Products)

Amniotic tissue provides a fertile substrate to dermal cells (including fibroblasts) to aid in skin healing. In-vitro data indicates that Axolotl Dualgraft supports fibroblast attachment and infiltration when placed on damaged tissue – this histological image demonstrates cellular attachment using an in-vitro model where fibroblasts were seeded and imaged 12-hours later. 

Cross-sectional image of Dermal Fibroblasts infiltrating Amnion Graft, Ingraldi, 2023

Amniotic tissue contains many extracellular matrix components found in dermal tissue. Axolotl DualGraft™ contain Hyaluronic Acid, Collagen I, III, V & IV, Laminin, Fibronectin and Proteoglycans sterilized to reduce the risk of immunogenicity. These components provide mechanical properties similar to native tissue in terms of elasticity, flexibility, stability, and permeability.

Axolotl Graft™ and Axolotl DualGraft™ are indicated as a wound covering and structural barrier. Axolotl graft products are processed through minimal manipulation techniques, retaining the native qualities of the amniotic membrane to function as a wound covering and as a structural barrier.

Axolotl Graft™ and Axolotl DualGraft™ are dehydrated human amnion membrane allografts derived from the amniotic lining of the placenta. The donor tissue is recovered and processed under sterile conditions, in accordance with all FDA guidelines and quality assurance standards in a controlled environment. Our allograft tissue products are terminally irradiated in the final package.

Axolotl graft products have received a letter of recommendation from the FDA Tissue Reference Group (TRG) and are manufactured in an AATB accredited manufacturing environment. 

Axolotl Graft™ and Axolotl DualGraft™ are marketed under Section 361 of the PHS act and regulated under 21 CFR Part 1271. Our allograft products are only intended for use in the United States.

Features & Benefits

  • Simple, suture-less placement
  • Versatile: Available in multiple sizes
  • Easy to Use: Membrane is orientation neutral (dual amnion)
  • Chorion-Free: Preferred in Orthopedics

 

Storage & Handling

  • Sterilized single use structural membrane
  • Can be stored at ambient room temperatures
  • 5 year shelf life
  • Available in a variety of sizes
  • Package includes allograft tracking record, patient labels for clinical use, and Instructions for Use

Donor Screening

  • Quality systems and validated processes ensures patient safety from the initial donor consultation to the surgeon’s transplantation of our allograft
  • Comprehensive medical and social histories are thoroughly reviewed by trained, qualified personnel on every donor. 
  • Rigorous testing for infectious diseases in accordance with Clinical Laboratory Improvement Amendments (CLIA) and 42 CFR Part 493, or equivalent requirements determined by the Centers for Medicare and Medicaid Services at FDA-registered laboratories.
  • All donations are reviewed for eligibility by donor and processor Medical Director.
  • Donor acceptance criteria follows FDA regulations and American Association Tissue Banking (AATB) guidelines
 
 

DualGraft Application Brochure

DualGraft 1-Page Brochure

Graft 1-Page Brochure

Axolotl DualGraft Sizes

Axolotl Graft Size