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Product Type: Allogeneic matrix
Other related brands
Lux Therapeutics | |
HCPCS : (Medicare DME co-payment per billable unit min / max: $0.00 / $0.00)
TheraMend is a patch product made from minimally processed, dehydrated amniotic membrane obtained from donated human tissue and is sterilized via gamma irradiation. It is an allogeneic matrix cellular and tissue-based skin substitute for wound healing.
INTENDED USES: Indications for use include topical wound covering or barrier for acute or chronic wounds.
CLAIMED BENEFITS: TheraMend is for single patient, one-time, homologous use only. TheraMend is applied directly to the wound and can be meshed or fenestrated as needed for drainage. The decision to alter the product for wound drainage is to be made by the healthcare practitioner and done in such a way to maintain sterility of the product. TheraMend is intended to be applied to the moist wound environment and can be hydrated with sterile saline if the healthcare practitioner deems it necessary for appropriate application. TheraMend may be applied for the duration of the wound or in an interval approved by the health care practitioner. The dose or sizing of the selected TheraMend is dependent on the wound size. TheraMend is packaged in single, one-time-use pouch, which is heat sealed to maintain a secure barrier and sterilized by gamma irradiation to meet a sterility assurance level of 10-6. Once opened, TheraMend should be used immediately or discarded to prevent contamination. TheraMend can be stored in the sealed packaging at ambient temperature.
Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients.
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Composition: Animal-derived |
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Composition: Human dermis with/without epidermis |
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Composition: Human placenta or umbilical cord |
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Composition: Viable (living) cells |
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Configuration: Fenestrated/ meshed |
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Configuration: Flowable |
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Configuration: Sheet |
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May apply on full-thickness wounds |
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May apply over exposed tendon/ bone/ muscle |
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May apply over infected tissue |
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Processing: Cryopreserved |
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Processing: Decellularized or irradiated |
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Processing: Dehydrated |
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Processing: Fresh (limited shelf life) |
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Processing: Hydrated |
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Processing: Minimally manipulated |
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Shelf life: Greater than 2 years |
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Storage: refrigeration needed |
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Storage: room temp |
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.
![Theramend, 3x3cm]( "Theramend, 3x3cm")
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* Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients.
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