Stravix® cryopreserved placental tissue, composed of the umbilical amnion and Wharton’s Jelly, retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue.
• Naturally conforms to complex anatomies and may be used over exposed bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh
• Can be easily applied in surgical procedures
• Intimately adapts to injured tissue to form an adhesion barrier
• Durable: 1mm to 3mm thick
• 10x tensile strength of amnion alone
• Immune neutral
• Alternative to autologous skin grafting that eliminates the pain, comorbidities, and procedure time associated with obtaining autologous grafts
• Available in multiple sizes to reduce wastage
Stravix® is limited to the homologous use as a wound cover or surgical wrap. The product may be used to cover or wrap acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, acute surgical wounds, pyoderma gangrenosum and epidermolysis bullosa. Stravix® may be used for acute and chronic wounds encompassing both upper extremity and lower extremity. Stravix® naturally conforms to complex anatomies and may be used over exposed bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh.
There are no known contraindications for Stravix®.
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, the tissue graft must be transplanted or discarded.
The tissue may not be sterilized.
The tissue 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 to the following reagents used for processing, disinfection, and storage and may remain on the product:
- Cryopreservation Solution: 5% v/v Dimethyl Sulfoxide, 1% v/v Human Serum Albumin (25% solution), 94% Sodium Chloride (0.9% solution)
- 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: Dulbecco's Phosphate Buffered Saline (DPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A)
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
• Transmission of diseases of unknown etiology;
• Transmission of known infectious agents including, but not limited to, viruses, bacteria, and fungi;
• Immune rejection of implanted Stravix®; or
• Loss of function and/or integrity of Stravix® due to resorption, fragmentation, and/or disintegration.
Please promptly report possible adverse event outcomes to Osiris Therapeutics, Inc. at 888-674-9551.
Stravix® has a two year shelf life and should be stored frozen at -75°C to -85°C (-103°F to -121°F).
Stravix® is composed of the umbilical amnion and Wharton's jelly, and retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts, and ephithelial cells of the native tissue.
Sodium chloride, DMSO, and HSA
|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|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available|
Hallux Rigidus Correction
Surgical Wound Repair
Refer to the instructions for use found in the package insert.
Non-adherent dressing and outer dressings.
Stravix® is supplied frozen (cryopreserved) and packaged in a sterile polycarbonate jar with a screw cap contained within a heat-sealed pouch contained within a tertiary box. This packaging configuration allows for the introduction of Stravix® into the sterile field.
Neither Osiris nor its affiliates make any claims concerning the biological or biomechanical properties of the provided tissue. Osiris disclaims all liability and responsibility for any misuse of tissue provided for clinical application.
Donor eligibility is determined based on FDA screening and testing criteria, which includes testing for the following:
Human Immunodeficiency Virus Type 1 Antibody
Human Immunodeficiency Virus Type 2 Antibody
Hepatitis C Virus Antibody
Hepatitis B Surface Antigen
Hepatitis B Core Antibody
Syphilis Rapid Plasma Reagin or Treponemal Specific Assay
Human T-Cell Lymphotropic Virus Type I Antibody
Human T-Cell Lymphotropic Virus Type II Antibody
HIV/HCV/HBV Nucleic Acid Test (NAT)
West Nile Virus Nucleic Acid Test (WNV NAT)
Each lot must be sterility negative per USP<71>
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.