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Vendaje®

Vendaje® is a natural, minimally manipulated structural tissue allograft composed of the amnion layer of the placental membrane. Vendaje® is intended for homologous use as a protective covering for soft tissue wounds. Amniotic tissue is a natural reservoir of extracellular matrix (ECM) components, growth factors, and anti-inflammatory cytokines which are known to support the body's natural healing processes.

BioStem Technologies, Inc.

BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure.
Benefits

• Serves as a versatile protective barrier to support the natural wound healing cascade
• The patented BioREtain® process preserves the natural integrity of the Vendaje® placental tissue/components critical to the wound care healing process
• Contains extracellular matrix (ECM) components, growth factors, and anti-inflammatory cytokines known to support the body's natural healing processes
• Easy to use
• Shelf-stable
• Terminally sterilized
• 4-year shelf-life

Indications

Vendaje® has versatile acute and chronic wound applications including: partial- and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor site/grafts, post-laser surgery, post-Mohs surgery, trauma wounds, partial-thickness burns, and draining wounds).

Contraindications

Vendaje® should not be used on: (1) areas with active or latent infection; and/or (2) on a patient with a disorder that would create an unacceptable risk of postoperative complications.

Warnings and Precautions

Same and similar potential medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation or application of this allograft. The licensed medical professional performing medical or surgical application or implantation of the allograft is responsible for informing patient of the risks associated with their treatment and the possibility of complications or adverse reactions. While proprietary processing and validated methods are employed by BioStem Life Sciences to eliminate potential deleterious components of the allograft, the possibility of transmission of RCDADs, rejection, or immunologic response exists.

Storage Requirements

Vendaje® allografts should be stored in a clean, dry environment at ambient conditions. It is the responsibility of the Tissue Dispensing Service, Tissue Dispensing Intermediary, and/or End-User Clinician to maintain the allograft in appropriate storage conditions until ready for use and to track expiration dates accordingly. Vendaje® has a 4-year shelflife.

How Supplied/Sizing
2cmx2cm, 2cmx4cm, 3cmx3cm, 4cmx4cm, 4cmx6cm, 4cmx8cm, 6cmx6cm, 8cmx8cm. Custom sizes available.
HCPCS Code
Product features
check_circle Assigned HCPCS code
check_circle Minimally manipulated
cancel Cryopreserved
check_circle Dehydrated
check_circle Desiccated
cancel Flowable
cancel Micronized
check_circle Sheet form
cancel Requires refrigeration
check_circle Shelf life greater than 2 years
cancel Shelf life limited
check_circle Indicated for acute wounds
check_circle Indicated for chronic wounds
check_circle Indicated for diabetic ulcers
check_circle Indicated for pressure ulcers
check_circle Indicated for surgical wounds
cancel Indicated for third-degree burns
check_circle 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

Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Hypertrophic Scars/Keloids
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Venous Ulcers

Mode of Use/Application

Remove the graft from the pouch and apply directly onto the area of treatment.

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