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Product Type: Composite matrix
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Organogenesis | |
HCPCS : Q4101 (Medicare DME co-payment per billable unit min / max: $0.00 / $0.00)
Apligraf is a living, cell-based, bilayered skin substitute.
INTENDED USE: For treating chronic venous leg ulcers and diabetic foot ulcers.
CLAIMED FEATURES: The lower layer contains bovine type 1 collagen and human fibroblasts to form a dermis-like structure that produces additional matrix proteins. Human keratinocytes form an epidermal layer to replicate the structure of the human epidermis. The human keratinocytes and fibroblasts are derived from neonatal foreskins. Apligraf stimulates the patient's own cells to regenerate tissue and heal the wound through mechanisms that may include the secretion of growth factors, cytokines, and matrix proteins. Does not contain melanocytes, Langerhans' cells, macrophages, lymphocytes, or tissue structures such as blood vessels, hair follicles, and sweat glands.
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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