Omnigraft Device Gains Diabetic Foot Ulcers Indication
The Food and Drug Administration (FDA) has approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat diabetic foot ulcers. Omnigraft is made of silicone, cow collagen, and shark cartilage. When placed over the ulcer, it allows for new skin and tissue to regenerate and heal the wound.
The FDA's approval is based on a clinical study in which the matrix device healed 51% of patient's ulcers after 16 weeks, compared to just 32% of a group of patients treated with standard foot ulcer care alone.
The new indication for the Omnigraft comes after its initial approval 1996 for the treatment of life-threatening burn injuries, before skin grafts were possible. Then in 2002, Omnigraft was approved to treat patients undergoing reconstructive surgery for burn scars who could not have skin grafts.
For more information visit FDA.gov.