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STRAVIX PL* Lyopreserved Umbilical Tissue for wound management and surgical applications is composed of the umbilical amnion and Wharton's jelly and retains native living cells, 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 sterilized.
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 two year shelf life and should be stored at room temperature.
| Assigned HCPCS code | |
| Cryopreserved | |
| Sheet form | ● |
| Shelf life greater than 2 years | |
| Requires refrigeration | |
| 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 |
Amputations
Arthrodesis
Bone Repair
Bunionectomy
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Fibromatosis
Hallux Rigidus Correction
Nerve Repair
Surgical Applications
Surgical Wounds
Tendon Repair
Ulcer Repair
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 ulcers, 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 two 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>
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.
Advanced Wound Bioactives
(Includes Collagenase SANTYL* Ointment, PROSHIELD* Foam & Spray Incontinent & Total Body Cleanser, PROSHIELD* Plus Skin Protectant, REGRANEX* (becaplermin) Gel 0.01%)
Toll-free: (800) 441-8227
Fax: (817) 900-4100
Email: snbiocc@smith-nephew.com
Cellular and/or Tissue-Based Products
(Includes GRAFIX PL*, GRAFIX*, STRAVIX*, OASIS® MICRO, OASIS® Wound Matrix, OASIS® Burn Matrix, and OASIS® Ultra Tri-Layer Matrix)
Website: www.osiris.com
Phone: (888) 674-9551
Fax: (443) 283-4419
Email: osiris-biosurgerycs@smith-nephew.com
Advanced Wound Care or Devices
(Includes all other products listed below)
Toll-free: (800) 876-1261
Fax: (727) 392-6914
Email: customercare.wound@smith-nephew.com
*Trademark of Smith+Nephew
