CHORIOFIX™ is a lyophilized human placental allograft that includes two layers of chorion with attached intermediate layer. CHORIOFIX™ is intended for use as a barrier to provide a protective environment in acute and chronic wounds.
• Lyophilized human placental-based allograft membrane that includes two layers of chorion with attached intermediate layer
• PURION® process preserves Extracellular Matrix (ECM) components including 300+ regulatory proteins
• Easy to apply
• No orientation required
• Can be repositioned after hydrating
• Compatible with compression therapy, negative pressure wound therapy (NPWT), and hyperbaric oxygen therapy (HBOT)
• Terminally sterilized
• Shelf-stable
• 5-year shelf life
CHORIOFIX™ is intended for use as a barrier to provide a protective environment in acute and chronic wounds.
CHORIOFIX™ 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.
• CHORIOFIX™ 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®.
It is the responsibility of the distributor and/or end-user clinician to store CHORIOFIX allografts in a clean, dry environment between 2–30°C prior to further distribution or transplant. Check the label for the expiration date.
Acute Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Wounds with light to moderate exudate
Non/Minimally Exudating Wounds
Pressure Ulcers
Superficial Wounds
Venous Ulcers
Preparation, Reconstitution and Use:
Prior to implantation, carefully follow the CHORIOFIX™ allograft preparation steps below using aseptic technique:
Wound Bed Preparation
Ensure the wound is free from clinical signs of infection. Prepare wound bed as needed.
Removing CHORIOFIX™ from Packaging
The outer peel pouch is NOT sterile. The inner pouch that contains CHORIOFIX™ is sterile (unless the pouches are damaged or compromised).
Carefully open the peelable corner of the outer pouch and extract 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 CHORIOFIX™ with fingers or non-toothed, sterile forceps. Use CHORIOFIX™ promptly after opening the inner, sterile pouch.
PLEASE TAKE GREAT CARE WHEN REMOVING THE PRODUCT FROM THE INNER POUCH.
CHORIOFIX™ Preparation
In a dry state, use sterile dry scissors to cut CHORIOFIX™ to fit the wound margins. Depth of the wound should be taken into consideration, allowing contact of CHORIOFIX™ with the wound bed and walls to the edges and overlapping, as appropriate. It is acceptable to overlap the wound margins with CHORIOFIX™ by 5-10mm to facilitate fixation to the tissue, or amount deemed medially necessary by the provider. If needed, CHORIOFIX™ can be fenestrated to accommodate wounds that produce copious amounts of exudate. CHORIOFIX™ can be applied wet or dry. CHORIOFIX™ can be hydrated while on the wound site with sterile saline solution. Simply apply several drops of sterile solution to CHORIOFIX™. During and following hydration, the embossment on CHORIOFIX™ will begin to fade.
CHORIOFIX™ Application
CHORIOFIX™ can be placed with either side facing the wound as it has no specific orientation requirements. CHORIOFIX™ can be secured to the site of application or to itself using staples or tissue adhesives, if desired.
Note: Not intended for use as a load bearing tissue.
Primary Dressing
CHORIOFIX™ should be covered with a non-adherent contact layer. CHORIOFIX™ should NOT be disturbed, if possible, for several days or before the next application, if needed. If an infection occurs at the graft site, treat infection per institution’s protocol.
Secondary Dressing
CHORIOFIX™ requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
Support Therapies
CHORIOFIX™ is compatible with offloading/compression/negative pressure therapies. CHORIOFIX™ can be used in conjunction with hyperbaric oxygen therapy.
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