AmnioBand® Viable Membrane is an aseptically processed, cryopreserved viable human amnion membrane allograft for use as an acute or chronic wound covering.
• Maintains inherent growth factors, matrix proteins, as well as a population of viable endogenous, adherent progenitor cells
• Can be used for a wide array of acute and chronic wounds
• Rigorous screening and testing process
• Available in multiple sizes
• Two year shelf life
• Conforms to anatomy and maintains surface contact
• Each lot tested for cell viability using a metabolic assay before releasing for distribution
AmnioBand® Viable Membrane is a cryopreserved human allograft that is minimally processed to retain its inherent extracellular matrix components as well as a viable population of endogenous, adherent progenitor cells. AmnioBand® Viable is intended to be used as a protective covering for internal and external tissue defects including acute, chronic and surgically created wounds. It is intended for single use only.
The presence of severe vascular compromise, active or latent infection or uncontrolled infection at the wound site may compromise the usefulness of the tissue.
Do not sterilize. Trace amounts of processing solution may remain. Prescription use only. Trace amounts of vancyomycin, amphotericin B, gentamicin, and dimethyl sulfoxide (DMSO 10%) may be present. Caution should be exercised if the patient is allergic to any of these substances. NOTE: No beta-lactam antibiotics are used during the processing of tissue.
Do not use if packaging seal is damaged or not intact, if packaging has physical damage, if label or identifying bar code is severely damaged and illegible, if expiration date has passed, if allograft is received thawed, if not used within one hour after thawing or if stored at a temperature not recommended.
Extensive medical screening procedures have been used in the selection of all tissue donors for MTF (please see Donor Screening and Testing of product insert). Transmission of infectious diseases such as HIV or hepatitis, as well as a theoretical risk of the Creutzfeld-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing.
Possible adverse effects of using human tissue include, but are not limited to: infection, fever, disease transmission and undesirable human response, loss of function and/or integrity of the allograft due to resorption, fragmentation and/or disintegration.
Store at or below -70°C.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Peel open the chevron end of the outer pouch and pass the inner film pouch into the sterile field. Place the sealed inner pouch containing the allograft and cryopreservation solution in a sterile basin containing room temperature sterile water or irrigant (i.e., normal saline or 5% dextrose in lactated Ringer’s solution) to thaw. Ensure that there is enough liquid to keep the pouch fully submerged. Note: the cryopreservation solution will turn to a reddish hue as it thaws. The pouch should be thawed in this basin until no ice crystals are visible, approximately three to four minutes. Do not thaw for more than 15 minutes. Carefully peel open the chevron end of the inner pouch. Transfer the plastic retainer containing the allograft into a sterile basin containing room temperature normal saline. Ensure that there is enough liquid to keep the retainer fully submerged. Discard the inner pouch and cryopreservation solution. Keep the retainer in the basin for at least five minutes. The allograft can be kept in this basin for up to one hour. The allograft should be used within one hour of thawing. Remove plastic retainer from the basin and open the retainer. Using sterile forceps, remove the allograft from the plastic retainer. The allograft is provided on a white plastic backing with the stromal side facing the backing. Do not implant the backing.
AmnioBand® Viable Membrane should be changed weekly or as needed.
Primary Dressing: AmnioBand® Viable Membrane should be covered with a non-adherent dressing.
Secondary Dressing: AmnioBand® Viable Membrane requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology. To further encourage healing, patient should be appropriately offloaded following each visit as per institution's standard protocols.
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