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Affinity® is the only fresh amniotic membrane wound covering, retaining viable cells, growth factors and cytokines in a native ECM structure. Aseptically processed and hypothermically preserved using the proprietary AlloFresh® method.
• Proprietary AlloFresh™ preservation method retains viable cells, native ECM structure, growth factors, and cytokines
Affinity® is an allograft intended for use in the management of acute and chronic wounds as well as appropriate surgical applications. Affinity® may be applied as a wound covering to a variety of partial- and full-thickness acute and chronic wounds, and wounds with exposed tendon, muscle, joint capsule, and bone. Affinity® can be applied from the onset and for the duration of the wound, weekly, or at the discretion of the health care practitioner.
Affinity® is contraindicated for use on clinically infected wounds. Affinity® is contraindicated for use in surgical implantation sites with active or latent infection. Please refer to the Affinity® Instructions for Use for additional information.
As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted. However, this risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening criteria, laboratory testing, aseptic processing, and microbiological culturing of final product. Single patient, single use only. Do not sterilize or re-sterilize. Do not use if expiration date has been exceeded.
Transmission of diseases of unknown etiology; transmission of known infectious agents including, such as viruses, bacteria and fungi; immune rejection of implanted HCT/P; loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation and/or disintegration.
All fresh allografts must be maintained at refrigerated temperature (between 1°C and 10°C) during storage.
| Assigned HCPCS code | ● |
| Minimally manipulated | |
| Cryopreserved | |
| Requires refrigeration | ● |
| Sheet form | |
| 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
Burns
Chronic Wounds
Dehisced Wounds
Diabetic Foot Ulcers
Pressure Ulcers
Surgical Wounds
Trauma Wounds
Venous Leg Ulcers
Wounds with Exposed Bone and Tendon
Using aseptic technique, remove the inner tray from the outer tray. Peel back the foil lid from the inner tray, remove Affinity®, and place the product on the inner side of the foil lid. Identify which side is facing up by touching the surface with a sterile cotton swab. If the stromal or sticky side is up, then turn Affinity® over, so that the stromal side is facing down on the foil lid. If the epithelial or non-sticky side is facing up, then you do not need to turn the product over. Rinse with a sterile irrigant prior to application. Slide Affinity® off the foil lid and onto the wound so that the stromal side is in contact with the wound bed. Two forceps can be used to help with orientation. Trim Affinity® as needed so that it is slightly larger than the wound bed.
A non-adherent, non-occlusive primary dressing may be used directly over Affinity®.
Organogenesis is a global leader in advanced wound care, offering a comprehensive portfolio of regenerative medicine products capable of supporting patients from early in the wound healing process through to wound closure, regardless of wound type.
