STRAVIX* Tissue

STRAVIX* Cryopreserved 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.

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: www.smith-nephew.com
Benefits

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 injuries, 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
• Durable: 1mm to 3mm thick
• Available in multiple sizes to reduce waste

Indications

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

Contraindications

There are no known contraindications for STRAVIX* Tissue.

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 should not be resterilized.
STRAVIX* 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.

Adverse Effects/Reactions

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* Tissue.

Storage Requirements

STRAVIX* Tissue has a 3 year shelf life and should be stored frozen at -75°C to -85°C (-103°F to -121°F).

How Supplied/Sizing
2cmx2cm, 2cmx4cm, 3cmx6cm, 3cmx6cm meshed.
Product features
cancel Assigned HCPCS code
cancel Minimally manipulated
check_circle Cryopreserved
cancel Requires refrigeration
cancel 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

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

Mode of Use/Application

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

Additional Recommended Dressings

Non-adherent dressing and outer dressings.

Construction

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.

Warranty

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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