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Affinity® is a fresh amniotic membrane containing viable cells, growth factors and cytokines and extracellular matrix proteins. Aseptically processed and hypothermically preserved using AlloFresh®, a proprietary storage system.
• Supports more natural wound healing as it is a fresh, living cellular amnion allograft
• Contains growth factors/cytokines that have angiogenic, regenerative and anti-inflammatory properties known to be important in the wound healing process
• Can be applied from head to toe and on wounds with exposed bone and tendon
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. See IFU 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, but not limited to, 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 | ● |
| Cryopreserved | |
| Sheet form | |
| Shelf life greater than 2 years | |
| Requires refrigeration | ● |
| 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
Remove Affinity® from its sterile packaging and rinse with a sterile irrigant using aseptic technique. Identify the stromal side (to be placed in contact with the wound bed) by touching a sterile cotton swab to both sides of Affinity®:
• The stromal side will be sticky.
• The epithelial side will be smooth.
Trim Affinity® as needed so that is slightly larger than the wound bed. Slide Affinity® onto the wound so that the stromal side is in contact with the wound bed (using two forceps at the corners of the product will help to maintain correct orientation).
A non-adherent, non-occlusive primary dressing may be used directly over the graft.
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.