Leneva® Allograft Adipose Matrix is comprised of human adipose extracellular matrix and provides a safe, off-the-shelf solution for the replacement of damaged or inadequate adipose tissue.
• Process utilized preserves the extracellular matrix of the allograft adipose
• Serves as a framework to support the cellular repopulation and vascularization at the surgical site
Leneva® Allograft Adipose Matrix is intended for the replacement of damaged or inadequate integumental adipose tissue. Leneva® Allograft Adipose Matrix may also be used for the reinforcement or supplemental support in underlying adipose tissue as the result of damage or naturally occurring defects.
Leneva® Allograft Adipose Matrix should not be placed in an area where native adipose does not normally exist.
Do not re-use Leneva® Allograft Adipose Matrix tissue. Do not sterilize Leneva® Allograft Adipose Matrix tissue. Do not combine with autologous lipoaspirate. Do not freeze Leneva® Allograft Adipose Matrix tissue. Do not use Leneva® Allograft Adipose Matrix if any of the packaging components are perforated or torn. A damaged pouch containing the tissue may result in degradation or contamination of the product.
NOTE: No antibiotics were used during the processing of Leneva® Allograft Adipose Matrix.
Aseptic technique must be adhered to throughout the procedure. Leneva® Allograft Adipose Matrix tissue should be used within two hours following preparation of the product. Leneva® Allograft Adipose Matrix has been formulated to be used with a 20G needle or larger bore needle/cannula. The use of a smaller bore needle may result in clogging.
Conditions that could potentially inhibit integration of Leneva® Allograft Adipose Matrix include, but are not limited to: immune response of non-infectious cause, including fever, low vascularity and/or ischemia of the surrounding tissue, local or systemic infection, mechanical trauma, poor nutrition or poor general medical condition, inability to cooperate with and/or comprehend post-operative instructions and infection at the injection site.
Possible adverse effects using human adipose include, but are not limited to: local or systemic infection, specific or non-specific immune response to some component of the graft and discoloration of the skin may occur if injected superficially. As with any injectable procedure, there is potential for swelling, tenderness, redness, bruising, pain or irritation at the injection site during the immediate post-operative period.
Store at ambient temperature. Do not refrigerate or freeze.
Diabetic Foot Ulcers