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EPICORD® Dehydrated Human Umbilical Cord Allograft

EPICORD® Dehydrated Human Umbilical Cord Allograft is a placental-based tissue product that acts as a barrier and provides a protective environment to help support the healing process.

MIMEDX Group, Inc.

MIMEDX is an industry leader in utilizing birth tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts for multiple health care sectors.
Toll free:(866) 477-4219 Fax:(770) 590-3550 Website: www.mimedx.com
Benefits

• Provides a protective environment for the support of the healing process
• Derived from the human umbilical cord
• Comprised of extracellular matrix of hyaluronic acid and collagen
• Retains over 250+ regulatory proteins
• Stores at room temperature storage for up to five years

Indications

EPICORD® is a dehydrated, non-viable cellular human umbilical cord allograft intended for homologous use to provide a protective environment for the healing process.

Contraindications

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.

Warnings and Precautions

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.

Adverse Effects/Reactions

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®.

Storage Requirements

EPICORD® allografts should be stored in a clean, dry environment at room temperature. EPICORD® allografts have a five year shelf life. Check the label for the expiration date.

How Supplied/Sizing
1cmx2cm, 2cmx3cm, 3cmx5cm.
HCPCS Code
Product features
check_circle Assigned HCPCS code
cancel Minimally manipulated
cancel Cryopreserved
check_circle Dehydrated
cancel Desiccated
cancel Flowable
cancel Micronized
check_circle Sheet form
cancel Requires refrigeration
check_circle Shelf life greater than 2 years
cancel Shelf life limited
check_circle Indicated for acute wounds
check_circle Indicated for chronic wounds
check_circle Indicated for diabetic ulcers
cancel Indicated for pressure ulcers
cancel Indicated for surgical wounds
cancel Indicated for third-degree burns
cancel Indicated for venous ulcers
check_circle Contact manufacturer for usage guidelines
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Hypertrophic Scars/Keloids
Moderate/Highly Exudating Wounds
Palliative Wounds
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Venous Ulcers

Mode of Use/Application

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® Preparation 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.

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