GRAFIX* cryopreserved placental membrane for wound management is composed of native living cells, growth factors, and extracellular matrix.
• Can be used for acute and chronic wounds, diabetic ulcers, pressure injuries, surgical wounds, burns, and venous ulcers
• Flexible, conforming cover that naturally adheres to complex anatomies and may be used over exposed bone, tendon, joint capsule, muscle, and hardware
• Designed for application directly to acute and chronic wounds
• Immune neutral
• No need for sutures or Steri-Strips®
• Available in multiple sizes to reduce wastage
GRAFIX* is limited to the homologous use as a wound cover/wrap/barrier.
There are no known contraindications for GRAFIX*.
Intended for use in one patient, on a single occasion only.
Do not use if package integrity has been compromised. Once the user breaks the seal on the pouch, GRAFIX* must be transplanted or discarded.
GRAFIX* may not be sterilized.
GRAFIX* is intended for use by qualified health care specialists such as physicians, podiatrists, or other appropriate health care professionals.
The same medical/surgical conditions or complications that apply to any medical/surgical procedure may occur during or following application.
The health care professional is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications or adverse reactions.
Caution should be exercised for patients with known sensitivities for reagents used for processing, disinfection, and storage which may remain on the product.
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
• Transmission of infectious agents or diseases of known or unknown etiology including, but not limited to fungi, bacteria, or viruses;
• Immune rejection of implanted GRAFIX*; or
• Loss of function and/or integrity of GRAFIX* due to resorption, fragmentation, and/or disintegration.
GRAFIX* has a 3 year shelf life and and should be stored frozen at -75°C to -85°C (-103°F to -121°F).
Venous Leg Ulcers
GRAFIX* can be applied in an office, hospital outpatient setting or in an operating room. GRAFIX* naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule, muscle, and hardware. GRAFIX* may be used to repair acute and chronic wounds, encompassing both upper extremity and lower extremity, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure injuries, dehisced surgical wounds, burns, acute surgical wounds, pyoderma gangrenosum, and epidermolysis bullosa.
Reapply weekly at the discretion of the responsible physician or health care professional for the duration of treatment.
Non-adherent dressing and outer dressings.
GRAFIX* cryopreserved placental membrane is supplied frozen in sheet form and packaged in a sterile cryobag contained within a heat-sealed pouch contained within a tertiary box. This packaging configuration allows for the introduction of GRAFIX* into the sterile field.
Except as otherwise expressly provided herein, Smith+Nephew, Inc. and its affiliates make no warranties or representations, express or implied, and to the extent permitted by law. The implied warranties or fitness for a particular purpose and merchantability are specifically disclaimed.
Donor eligibility is determined based on FDA screening and testing criteria, which includes testing for the following:
Human Immunodeficiency Virus Type 1 Antibody (HIV)
Human Immunodeficiency Virus Type 2 Antibody (HIV)
Hepatitis C Virus Antibody (HCV)
Hepatitis B Surface Antigen (HBV)
Hepatitis B Core Antibody (HBV)
Syphilis Rapid Plasma Reagin (RPR) or Treponemal Specific Assay
Human T-Cell Lymphotrophic Virus Type I Antibody (HTLV)
Human T-Cell Lymphotrophic Virus Type II Antibody (HTLV)
HIV/HCV/HBV Nucleic Acid Test (NAT)
West Nile Virus (WNV) Nucleic Acid Test (NAT)
Each lot must be sterility negative per USP<71>
Live cells present across 70% of the membrane sampled
Growth factors are present in GRAFIX PRIME*
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