Integra® BioFix® Flow Placental Tissue Matrix Allograft
Integra® BioFix® Flow Placental Tissue Allograft is a sterile, human tissue allograft, derived from decellularized particulate human placental connective tissue matrix.
• Ready to implant – no mixing necessary
• Precisely targets defects using a range of needle gauges for ease of implantation
• Room temperature storage with a five year shelf life
Integra® BioFix® Flow Placental Tissue Matrix Allograft is intended for homologous use as a wound covering for surgical sites, voids, and tissue defects.
Contraindicated for use on patients exhibiting gross infection at the transplantation site.
Do not re-sterilize.
BioFix® is intended for single patient use. Do not reuse.
Do not use if: package integrity has been violated, opened or damaged; mishandling has caused possible damage or contamination; seal is broken or compromised.
Once BioFix® has expired, it must be discarded.
Do not implant in the presence of active infection.
After use, handle and dispose of all unused portions and packaging in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
BioFix® may contain trace amounts of antibiotic residuals such as amphotericin, penicillin, streptomycin and neomycin used in low doses and rinsed during processing.
Inherent uncertainty exists in medical and social histories and laboratory testing which may not detect known or unknown pathogens. Therefore, the following complications may occur with tissue transplantation:
• Loss of integrity of transplanted tissue with resorption, disintegration, and associated loss of continuity.
• Immune response to transplanted tissue.
• Transmission of known pathogens including Hepatitis B or C, Human T-cell Leukemia/Lymphotropic Virus, Human Immunodeficiency Virus 1 and 2, syphilis, or bacteria.
• Transmission or causation of diseases of unknown etiology and characteristics.
Store at ambient temperature (five year shelf life). Keep away from excessive heat. Do not freeze.
|Assigned HCPCS code|
|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|
Open BioFix® Flow box and remove the clear product pouch. Using aseptic technique, peel open the outer clear pouch and present the sterile vial onto the sterile field. Open the vial and add desired amount of sterile saline. Close the vial and vigorously shake to mix. Open the vial for the application. Draw into syringe using an 18 gauge needle (or similar). Change to a 23 gauge needle (or similar) to inject. Add additional saline as needed.
To apply, feather graft around and into the intended site, injecting approximately every 0.5cm, moving slowly to allow graft to settle into the tissues. Provide as much coverage as possible, directly into, around, and under the surgical wound, defect, suture line, or desired tissue layers.
Note: The goal is to provide consistent, even coverage, to make the components in the graft accessible to the entire intended area.
Integra LifeSciences, a worldwide leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development of cost-effective solutions used to treat millions of patients every year. With over two decades of clinical efficacy and a reputation for delivering quality, Integra's advanced wound care products are a premiere solution for clinicians.