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Product Type: Allogeneic matrix
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Organogenesis | Model: |
HCPCS : Q4106 (Medicare DME co-payment per billable unit min / max: $0.00 / $0.00)
Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute (allogeneic matrix).
INTENDED USES: For use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.
CLAIMED FEATURES: Composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. It is manufactured from human fibroblast cells derived from donated newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold.The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles.
OPTIONS: 2 in x 3 in (5 cm x 7.5 cm),1 piece in a clear bag
Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients.
Composition: Animal-derived
Composition: Human dermis with/without epidermis
Composition: Human placenta or umbilical cord
Composition: Viable (living) cells
Configuration: Fenestrated/ meshed
Configuration: Flowable
Configuration: Sheet
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
May apply over infected tissue
Processing: Cryopreserved
Processing: Decellularized or irradiated
Processing: Dehydrated
Processing: Fresh (limited shelf life)
Processing: Hydrated
Processing: Minimally manipulated
Shelf life: Greater than 2 years
Storage: refrigeration needed
Storage: room temp
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The addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing, after at least a 30 day period of comprehensive conservative therapy. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. • Human skin allografts are derived from donated human skin (cadavers) • Allogeneic matrices are derived from human tissue (fibroblasts or membrane) • Composite matrices are derived from human keratinocytes, fibroblasts and xenogeneic collagen • Acellular matrices are derived from xenogeneic collagen or tissue

For Medicare to cover this product, it needs to be ordered and applied by your clinician. A patient cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement for it.

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