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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.
Integra LifeSciences Corp.
Integra LifeSciences Corp.
Integra offers innovative solutions in neurosurgery with a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. The regenerative tissue technologies portfolio includes products that address soft tissue, nerve and tendon repairs and are used in the treatment of acute and chronic wounds, burns, as well as plastic and reconstructive surgery.
• 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.
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.
