GRAFIX* Membrane Products
GRAFIX* lyopreserved and cryopreserved placental membrane products and surgical applications retain all components of placental tissue, including native placental cells.
Product Literature
Smith+Nephew, Inc.
For over 150 years, Smith+Nephew has taken a pioneering approach to product design and services, helping to reduce the human and economic costs of wounds. *Trademark of Smith+NephewBenefits
• Can be used for acute and chronic wounds such as, 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 structures such as 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
Indications
GRAFIX* Membrane products are limited to the homologous use as a wound cover/wrap/barrier.
Contraindications
There are no known contraindications for these products.
Warnings and Precautions
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* Membrane Products must be transplanted or discarded.
GRAFIX* Membrane Products may not be sterilized.
GRAFIX* Membrane Products are 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.
Adverse Effects/Reactions
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* Membrane Products; or
• Loss of function and/or integrity of GRAFIX* Membrane Products due to resorption, fragmentation, and/or disintegration.
Storage Requirements
GRAFIX* Cryopreserved Placental Membrane has a 3 year shelf life and and should be stored frozen at -75°C to -85°C (-103°F to -121°F). GRAFIX* PL Lyopreserved Placental Membrane Tissue has a 2 year shelf life and should be stored at room temperature.
How Supplied/Sizing
1.5cmx2cm, 2cmx3cm, 3cmx4cm, 5cmx5cm. Round: 16mm.
Patient condition
Product features
Assigned HCPCS code
Minimally manipulated
Cryopreserved
Requires refrigeration
Sheet form
Shelf life greater than 2 years
Shelf life limited
Indicated for acute wounds
Indicated for chronic wounds
Indicated for diabetic ulcers
Indicated for pressure ulcers
Indicated for surgical wounds
Indicated for third-degree burns
Indicated for venous ulcers
Contact manufacturer for usage guidelines
Other features
Educational Material Available
Free Samples/Trials Available
Published Clinical Article Available
Recommended Use
Acute Wounds
Arterial Ulcers
Burns
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Pressure Ulcers
Pyoderma Gangrenosum
Superficial Wounds
Surgical Dehiscence
Surgical Incisions
Trauma
Venous Leg Ulcers
Mode of Use/Application
GRAFIX* Membrane Products can be applied in an office, hospital outpatient setting or in an operating room. GRAFIX* Membrane Products naturally conform to complex anatomies and may be used over exposed bone, tendon, joint capsule, muscle, and hardware. GRAFIX* Membrane Products 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.
Removal & Change Frequency
Reapply weekly at the discretion of the responsible physician or health care professional for the duration of treatment.
Additional Recommended Dressings
Non-adherent dressing and outer dressings.
Construction
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. GRAFIX PL* is supplied in sheet form between two (2) mesh applicators and packaged within a heat-sealed pouch contained within a tertiary box. This packaging configuration allows for the introduction of GRAFIX PL* into the sterile field.
Warranty
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.
Technical Specifications
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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