GrafixPL PRIME™ (lyopreserved placental membrane) is a lyopreserved amnion matrix retaining the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue.
• 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
• Alternative to autologous skin grafting that eliminates the pain, comorbidities and procedure time associated with obtaining autologous grafts
• No need for sutures or Steri-Strips®
• Available in multiple sizes to reduce wastage
GrafixPL PRIME™ may be used to repair acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, burns, acute surgical wounds, pyoderma gangrenosum, and epidermolysis bullosa. The product is limited to the homologous use as a wound cover/wrap/barrier. GrafixPL PRIME™ may be used for acute and chronic wounds, encompassing both upper extremity and lower extremity. GrafixPL PRIME™ naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule and muscle.
There are no known contraindications for this product.
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 foil pouch, the tissue graft must be transplanted or discarded.
The tissue may not be sterilized.
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 to the following reagents used for processing, disinfection, and storage and may remain on the product:
- Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco's Phosphate Buffered Saline (DPBS)
- Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco's Modified Eagle's Medium (DMEM)
- Processing Solution: DMEM, DPBS, 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v Trehalose in DPBS
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
• Transmission of disease of unknown etiology;
• Transmission of known infectious agents including, but not limited to, viruses, bacteria, and fungi;
• Immune rejection of implanted GrafixPL PRIME™; or
• Loss of function and/or integrity of GrafixPL PRIME™.
Please promptly report possible adverse event outcomes to Osiris Therapeutics, Inc. at 888-674-9551.
GrafixPL PRIME™ should be stored at room temperature prior to application. Refer to the expiry date on the labeled package.
Native amnion tissue which contains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells.
|Assigned HCPCS code||●|
|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|
Deep Tunneling Wounds
Diabetic Foot Ulcers
Venous Leg Ulcers
GrafixPL PRIME™ can be applied in an office, hospital outpatient setting, or in an operating room. Proper aseptic technique should be followed when applying the product.
Reapply weekly at the discretion of the responsible physician for the duration of the treatment of the patient’s wound.
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.
GrafixPL PRIME™ 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 GrafixPL PRIME™ into the sterile field.
Neither Osiris nor its affiliates make any claims concerning functional activities of GrafixPL PRIME™. Although well characterized in scientific literature and studies, preservation of tissue integrity including cells may not be indicative of clinical outcome. Osiris disclaims all liability and responsibility for any misuse of tissue provided for clinical application. Please promptly report adverse outcomes to Osiris at 888-674-9551.
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) (if applicable)
Each lot much be sterility negative per USP <71>
Presence of growth factors and viable cells across ≥ 70% of the tissue tested.
Osiris Therapeutics, Inc. researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall health care costs.