STRAVIX PL* Lyopreserved Umbilical Tissue is a structural placental allograft for wound management and surgical applications that retains all the native components including growth factors and extracellular matrix.
For detailed product information, including indications for use, contraindications, effects, precautions, and warnings, please consult the product's Instructions for Use (IFU) prior to use.
• Can be used for acute and chronic wounds, diabetic ulcers, pressure ulcers, surgical wounds, and venous ulcers
• 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
• Available in multiple sizes to reduce waste
STRAVIX PL* Tissue is limited to the homologous use as a wound cover, surgical barrier, or surgical wrap.
There are no known contraindications for STRAVIX PL* Tissue.
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, STRAVIX PL* Tissue must be transplanted or discarded.
STRAVIX PL* Tissue should not be resterilized.
STRAVIX PL* 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 for reagents used for processing, disinfection, and storage which may remain on the product.
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; or
• Immune rejection of implanted STRAVIX PL* Tissue.
STRAVIX PL* Tissue has a 2 year shelf life and should be stored at room temperature.
Hallux Rigidus Correction
STRAVIX PL* Tissue naturally conforms to complex anatomies and may be used over exposed bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh. STRAVIX PL* Tissue may be used to cover or wrap 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. Refer to the instructions for use found in the package insert.
Non-adherent dressing and outer dressings.
STRAVIX PL* Tissue is supplied in sheet form between 2 mesh applicators and packaged within a heat-sealed pouch contained within a tertiary box. This packaging configuration allows for the introduction of STRAVIX PL* Tissue into the sterile field.
Except as otherwise expressly provided herein, Smith+Nephew 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.
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 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 must be sterility negative per USP<71>
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