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BIOVANCE® Human Amniotic Membrane Allograft is a decellularized, dehydrated human amniotic membrane (DDHAM) with a preserved natural epithelial basement membrane and an intact extracellular matrix structure with its biochemical components. The epithelial basement membrane and extracellular matrix provide a natural scaffold that allows cellular attachment or infiltration and growth factor storage.
• Matrix of human proteins to support cellular ingrowth
• Barrier to microbes to hinder infections
• Non-immunogenic to further minimize the risk of inflammatory reactions
• Translucent to allow wound's progress toward healing to be seen
• Flexible to conform to an irregular surface
• Broad range of indications
• Convenient five year shelf life and storage at room temperature
• Available in multiple sizes
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 with minimized adhesion or fibrotic scarring. 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.
If a patient has an adverse reaction related to the use of BIOVANCE®, immediately discontinue use.
Store in a clean, dry environment at ambient room temperature.
Dehydrated, decellularized human amniotic membrane
| Assigned HCPCS code | ● |
| Cryopreserved | |
| Dehydrated | ● |
| Desiccated | |
| Flowable | |
| Micronized | |
| Sheet form | ● |
| Requires refrigeration | |
| Shelf life greater than 2 years | ● |
| 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 | ● |
Acute Wounds
Arterial Wounds
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
First- and Second-Degree Burns
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Mohs Surgery Sites
Non/Minimally Exudating Wounds
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Venous Ulcers
These recommendations are designed to serve only as general guidelines. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
Discard any unused portions of BIOVANCE® as per institutional procedures.
BIOVANCE® should not be applied until excessive exudate or bleeding, acute swelling and infection are controlled.
BIOVANCE® should not be applied for structural support.
Each package of BIOVANCE® is intended for use on a single patient on one occasion.
No specific orientation (which side is up or down) of BIOVANCE® is required.
Instructions for Wound Care:
1. Always handle BIOVANCE® using aseptic techniques.
2. The inner pouch is sterile and may be placed in the surgical field; however, the outer pouch is not sterile and should be handled accordingly.
3. Sterile atraumatic forceps should be used to remove BIOVANCE® from its inner peel-pouch.
4. Prepare the wound area using standard methods to ensure the wound is free of debris and necrotic tissue; if necessary, debride the wound to ensure the wound edges and base contain viable tissue prior to placement of BIOVANCE®.
5. BIOVANCE® can be trimmed to the desired shape and size when dry out of the package. If the wound is larger than a single sheet, multiple sheets of BIOVANCE® (overlapping edges) may be used to cover the open wound area.
6. Apply BIOVANCE® dry and allow wound fluid absorption to hydrate or add sterile saline or other sterile isotonic solution as needed to hydrate, then smooth the BIOVANCE® so that it conforms to the wound surface. There is no specific orientation required.
7. The clinician should determine how to anchor BIOVANCE®. When suturing, taping or stapling the sheet, ensure that BIOVANCE® overlaps adjacent intact skin.
8. If there is a concern about wound fluid collection beneath BIOVANCE®, small slits may be made through the allograft to facilitate drainage.
9. After application of BIOVANCE®, use an appropriate, nonadherent, secondary dressing to maintain a moist wound environment and the placement of the tissue.
10. Change the secondary dressing as needed to maintain a moist, clean wound area. Wound type, location, size, depth, amount of exudate and user preference determine the optimal secondary dressing.
11. Do not forcibly remove sections of BIOVANCE® that are adhered to the wound. On inspection, if BIOVANCE® is no longer covering the wound, or healing progress has slowed, place an additional piece of BIOVANCE® over the wound.
12. Discontinue BIOVANCE® treatment upon complete healing of the wound.
Do not forcibly remove sections of BIOVANCE® that are adhered to the wound. On inspection, if BIOVANCE® is no longer covering the wound, or healing progress has slowed, place an additional piece of BIOVANCE® over the wound.
Discontinue BIOVANCE® treatment upon complete healing of the wound.
After application of BIOVANCE®, use an appropriate, non-adherent, secondary dressing to maintain a moist wound environment and the placement of the tissue.
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.
Non-pyrogenic
Sterile
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.
Celularity, Inc. is a biotechnology company that produces cells and tissues derived from the postpartum placenta. Its portfolio of products supports the body's ability to regenerate tissue and includes BIOVANCE® Human Amniotic Membrane Allograft, Interfyl® Human Connective Tissue Matrix and UltraMIST® System.