BIOVANCE® is a decellularized, dehydrated human amniotic membrane allograft that provides a protective cover from the surrounding environment.
• Provides a cover and protects from the surrounding environment
• Human amniotic membrane allograft
• No orientation required
• 10 year shelf life
• Ambient room temperature storage
• Out of package ready
BIOVANCE® is an allograft intended for use as a biological membrane covering that provides the extracellular matrix while supporting the repair of damaged tissue. As a barrier membrane, BIOVANCE® is intended to protect the underlying tissue and preserve tissue plane boundaries. Indications include, but are not limited to, surgical covering, wrap or barrier, application to partial- and full-thickness, acute and chronic wounds (such as traumatic and complex wounds, burns, surgical and Mohs surgery sites; and diabetic, venous, arterial, pressure and other ulcers), including wounds with exposed tendon, muscle, bone or other vital structures.
BIOVANCE® is contraindicated in patients with a known hypersensitivity to BIOVANCE®.
If a patient has an adverse reaction related to the use of BIOVANCE®, immediately discontinue its use. BIOVANCE® should not be used on clinically infected wounds.
The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize.
BIOVANCE® must be used prior to the expiration date on the product pouch.
BIOVANCE® should not be used together with a collagenase product on the wound.
Adverse reactions or outcomes that potentially involve the use of BIOVANCE® must be reported promptly to the Celularity Inc. Customer Service at 1-844-963-2273.
Store in a clean, dry environment at ambient room temperature.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Aseptic technique. Apply topically. No specific orientation. Can secure with sutures or steri-strips. Secondary cover dressing of HCP's choice.
Cover with a non-adherent dressing.
BIOVANCE® is a decellularized, dehydrated human amniotic membrane (DDHAM). The epithelial basement membrane and collagen-rich extracellular matrix of this allograft provide a natural scaffold for cell attachment and proliferation needed for tissue repair with minimized inflammation and scarring. BIOVANCE® is an aseptically processed product and is terminally sterilized with E-beam irradiation.
BIOVANCE® is tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens.
Testing for endotoxins is conducted to assure levels are below 20 EU/sheet. BIOVANCE® is non-pyrogenic.
BIOVANCE® is an aseptically processed product and is terminally sterilized with E-beam irradiation.
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