EpiCord® Dehydrated Human Umbilical Cord Allograft is a placental-based tissue product that acts as a barrier and provides a protective environment to help promote healing.
• Provides a protective environment for the healing process
• Contains essential regulatory proteins
• Umbilical cord consists of amniotic epithelium and Wharton's jelly containing extacellular matrix composed of collagen, proteoglycans and hyaluronic acid
• Stores at ambient condition for up to five years
EpiCord® is a dehydrated, non-viable cellular human umbilical cord allograft intended for homologous use to provide a protective environment for the healing process.
EpiCord® allografts should not be used on (1) areas with active or latent infection and/or (2) a patient with a disorder that would create an unacceptable risk of post-operative complications.
EpiCord® allografts remain suitable for transplantation in an unopened, undamaged package, under proper storage conditions.
Please inspect the integrity of the package upon receipt. If package and contents appear defective or damaged in any way, immediately contact the distributor.
This allograft is intended for single-patient use only. Discard all unused material.
The procedure should be performed by an authorized medical professional.
Strict donor screening and laboratory testing, along with dedicated processing and sterilization methods, are employed to reduce the risk of any disease transmission.
However, as with all biological implants, an absolute guarantee of tissue safety is not possible. This allograft has the potential to transmit infectious disease to the recipient.
The reaction of the body to any biological implant is not completely understood.
Caution should be used when treating patients with a known sensitivity to aminoglycoside antibiotics.
Discard all damaged, mishandled or potentially contaminated tissue.
This product has not been tested in combination with other products.
Do not re-sterilize.
As with any procedure, the possibility of infection exists.
Proprietary processing and validated sterilization methods are employed to eliminate potential deleterious components of the allograft. However, as with all biological implants, the possibility of rejection exists.
Any adverse reactions, including the suspected transmission of disease attributable to this allograft, should be reported immediately to MiMedx®.
EpiCord® allografts should be stored in a clean, dry environment at ambient conditions. The allografts have a five year shelf life. Check the label for the expiration date.
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|Shelf life limited|
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|Indicated for diabetic ulcers|
|Indicated for pressure ulcers|
|Indicated for surgical wounds|
|Indicated for third-degree burns|
|Indicated for venous ulcers|
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Moderate/Highly Exudating Wounds
Preparation, Reconstitution and Use:
Prior to implantation, carefully follow EpiCord® allograft preparation steps below using aseptic technique:
Removing EpiCord® from packaging:
The outer peel pouch is not sterile. The inner pouch which contains the EpiCord® allograft is sterile (unless the pouches are damaged or compromised).
Carefully open the peelable corner of the outer pouch and present the inner pouch using aseptic technique. Ensure the inner pouch does not come in contact with any portions of non-sterile surface of the outer pouch.
Using aseptic technique, slowly peel a corner of the inner peel pouch and grasp the allograft with fingers or non-toothed, sterile forceps.
Use the EpiCord® allograft promptly after opening the inner, sterile pouch.
Please take great care when removing the product from the internal pouch.
EpiCord® Preperation and Application:
In its dry state and prior to hydration, the allograft may be cut with sharp scissors to the appropriate and approximate size required.
The allograft should then be placed on the site.
The allograft can then be hydrated while on the site with sterile saline solution, if desired.
Suture material (absorbable, non-absorbable) and/or tissue adhesives can be used to fixate EpiCord® allografts to the site of application or to itself, if desired.
Cover to maintain a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
MiMedx Group, Inc. is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of health care.