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STRAVIX* Tissue Products

STRAVIX* Lyopreserved and Cryopreserved Umbilical Tissue Products are structural placental allografts for wound management and surgical applications that retain all the components of umbilical tissue including native placental cells, growth factors and a hyaluronic acid rich extracellular matrix.

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Smith+Nephew, Inc.

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. *Trademark of Smith+Nephew
Toll free:(800) 876-1261 Fax:(817) 900-4100 Website:

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 such as, diabetic ulcers, pressure injuries, surgical wounds, and venous ulcers
• Naturally conforms to complex anatomies and may be used over exposed structures such as bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh
• Can be easily applied to augment surgical procedures across multiple specialties
• Intimately adapts to injured tissue to form an adhesion barrier
• Durable: 1mm to 3mm thick
• Available in multiple sizes to reduce waste


STRAVIX* Tissue Products are limited to the homologous use as a wound cover, surgical barrier, or surgical wrap.


There are no known contraindications for these products.

Warnings and Precautions

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* Tissue
must be transplanted or discarded.
STRAVIX* Tissue Products should not be resterilized.
STRAVIX* Tissue Products are 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.

Adverse Effects/Reactions

Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications oftissue 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* Tissue Products.

Storage Requirements

STRAVIX* Cryopreserved Umbilical Tissue has a 3 year shelf life and should be stored frozen at -75°C to -85°C (-103°F to -121°F). STRAVIX PL* Lyopreserved Umbilical Tissue has a 2 year shelf life and should be stored at room temperature.

How Supplied/Sizing
2cmx2cm, 2cmx4cm, 3cmx6cm, 3cmx6cm meshed.
Product features
check_circle Assigned HCPCS code
check_circle Minimally manipulated
cancel Cryopreserved
cancel Requires refrigeration
check_circle Sheet form
check_circle Shelf life greater than 2 years
cancel Shelf life limited
cancel Indicated for acute wounds
cancel Indicated for chronic wounds
cancel Indicated for diabetic ulcers
cancel Indicated for pressure ulcers
cancel Indicated for surgical wounds
cancel Indicated for third-degree burns
cancel Indicated for venous ulcers
cancel Contact manufacturer for usage guidelines
Other features
check_circle Educational Material Available
cancel Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Bone Repair
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Hallux Rigidus Correction
Nerve Repair
Surgical Applications
Surgical Wounds
Tendon Repair
Ulcer Repair

Mode of Use/Application

STRAVIX* Tissue Products naturally conform to complex anatomies and may be used over exposed structures such as bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh. STRAVIX* Tissue Products 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.

Additional Recommended Dressings

Non-adherent dressing and outer dressings.


STRAVIX* Tissue 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* Tissue into the sterile field. 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.

Technical Specifications

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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