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.
• Anti-adhesion and anti-inflammatory barrier aids natural wound repair, reduces inflammation, reduces scarring, and protects from infection
• Designed for application directly to acute and chronic wounds
• Thicker and stronger than amnion alone
• Immune neutral
• Alternative to autologous skin grafting that eliminates the pain, comorbidities and procedure time associated with obtaining autologous grafts
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 Bulosa. Stravix® may be used in wounds encompassing both upper extremity and lower extremity acute and chronic wounds. 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 grafts must be transplanted or discarded.
The tissue may not be sterilized or re-sterilized.
The tissue is intended for use by qualified healthcare specialists such as physicians, podiatrists, or other appropriate healthcare professionals.
The same medical/surgical conditions or complications that apply to any medical/surgical procedure may occur during or following application.
The healthcare 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: 50 μg/mL Gentamicin Sulfate, 50 μg/mL Vancomycin reconstituted in Water for Injection (WFI), 2.5 μg/mL Amphotericin B, 1X Dulbecco’s Modified Eagle’s Medium (DMEM)
- Processing Solution: Dulbecco’s Phosphate Buffered Saline (DPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACDA)
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 at the email address on this website.
Stravix® has a two year shelf life and should be stored frozen at -75°C to -85°C (-103°F to -121°F).
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
|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|
|Variety of sizes||●|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available|
• Bone Repair
• Deep Wounds
• Hallux Rigidus Correction
• Nerve Repair
• Surgical Applications
• Surgical Wound Repair
• Tendon Repair
• Ulcer Repair
For directions of use, refer to the directions found on the package insert.
Non-adherent dressing and outer dressings.
Stravix® is packaged in a sterile polycarbonate jar contained within a heat-sealed pouch. This packaging configuration allows for the introduction of Stravix® into the sterile field.
Neither Osiris Therapeutics, Inc. (Osiris), nor its affiliates expressly or by implication warrant any tissue selected, recovered, processed or distributed by itself, distributors, representatives, or agents. Please promptly report adverse outcomes to Osiris at the address on this website.
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
Human Immunodeficiency Virus Nucleic Acid Test (NAT)
Hepatitis B Virus Nucleic Acid Test (HIV NAT)
Hepatitis C Virus Nucleic Acid Test (HCV NAT)
West Nile Virus Nucleic Acid Test (WNV NAT)
Each lot must be sterility negative per USP<71>
Osiris Therapeutics, Inc. is a leader in researching and developing regenerative medicine products that improve lives. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care.