GRAFIX PL*

GRAFIX PL* lyopreserved placental membrane for wound management is composed of native living cells, growth factors and an intact extracellular matrix.

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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+Nephew
Toll free:(800) 876-1261 Fax:(817) 900-4100 Website: www.smith-nephew.com
Benefits

• 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

Indications

GRAFIX PL* is limited to the homologous use as a wound cover/wrap/barrier.

Contraindications

There are no known contraindications for this product.

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 PL* must be transplanted or discarded.
GRAFIX PL* may not be sterilized.
GRAFIX PL* 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.

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 PL*; or
• Loss of function and/or integrity of GRAFIX PL*.

Storage Requirements

GRAFIX PL* should be stored at room temperature prior to application. Refer to the expiry date on the labeled package.

How Supplied/Sizing
1.5cmx2cm, 2cmx3cm, 3cmx3cm, 3cmx4cm, 5cmx5cm. Round: 16mm.
HCPCS Code
Product features
check_circle Assigned HCPCS code
cancel Minimally manipulated
cancel Cryopreserved
cancel Requires refrigeration
cancel Sheet form
check_circle Shelf life greater than 2 years
cancel Shelf life limited
cancel Indicated for acute wounds
cancel Indicated for chronic wounds
cancel 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
cancel Contact manufacturer for usage guidelines
Other features
check_circle Educational Material Available
cancel Free Samples/Trials Available
check_circle 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
Venous Ulcers

Mode of Use/Application

GRAFIX PL* can be applied in an office, hospital outpatient setting or in an operating room. Proper aseptic technique should be followed when applying the product. GRAFIX PL* naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule, and muscle. GRAFIX PL* 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 for the duration of the treatment of the patient's wound.

Additional Recommended Dressings

Cover the applied graft in the wound with a non-adherent dressing followed by saline moistened gauze to fill but not pack the wound, or use another dressing as appropriate for the wound type.

Construction

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 or Treponemal Specific Assay
Human T-Cell Lymphotropic Virus Type I Antibody (HTLV)
Human T-Cell Lymphotropic Virus Type II Antibody (HTLV)
HIV/HCV/HBV Nucleic Acid Test (NAT)
West Nile Virus (WNV) Nucleic Acid Test (NAT)

Each lot much be sterility negative per USP <71>
Presence of growth factors and viable cells across ≥ 70% of the tissue tested.

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