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Integra® BioFix® Plus Amniotic Membrane Allograft
Integra® BioFix® Plus Amniotic Membrane Allograft is a sterile, human tissue allograft derived from allogeneic dehydrated and decellularized amniotic membrane. Approximately 200µm thick.
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.
2cmx4cm, 4cmx4cm, 4mx6cm, 4cmx8cm. Approx. thickness: 200µm.
• Membranes can be implanted on either side to provide an effective covering and gliding surface over the tissue
• Require no preparation for use—implantable wet or dry and adhere to the wound bed without the need for fixation
• Create no additional bulk at the wound site
Integra® BioFix® Plus Amniotic Membrane 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® box and remove the clear product pouch. Using aseptic technique, peel open the outer clear pouch and present the sterile inner pouch onto the sterile field. Peel open the inner pouch and remove the graft from its clear pouch using dry forceps. Gently position the graft onto intended site, completely covering the area (direct contact with the site is key). If the graft needs to be repositioned or unfolded in any manner, irrigate gently with saline and reposition using forceps. Suturing is not recommended. The graft will adhere naturally to the patient's wet tissue. The graft may be affixed using Dermabond®, Steri-Strip®, fibrin sealant or other preferred fixation technique if necessary.
Note: Prior to or after implantation, the graft may be hydrated with sterile saline or other sterile solution if desired.
For minimally invasive applications: The graft may be hydrated in a bowl of sterile saline prior to application. To apply, gently remove the graft using a grasper, and place down the cannula onto the intended area. Use the blunt ends of two graspers to unfold the graft, spread it out and nudge it into place.
