LifeSciences’ Omnigraft Snags New Indication
The FDA has blessed Plainsboro, N.J.-based LifeSciences with a new indication for its Integra Omnigraft dermal regeneration matrix to treat certain diabetic foot ulcers.
Omnigraft — which is made of silicone, cow collagen and shark cartilage — provides an environment for new skin and tissue to regenerate and heal the wound after placing the device over the ulcer.
The new indication is based on a clinical trial in which 51 percent of patients treated with Omnigraft saw their ulcers heal in 16 weeks versus 32 percent of patients treated with standard diabetic foot ulcer care alone.
The device first scooped up FDA approval in 1996 for the treatment of life-threatening burn injuries when the use of a patient’s own skin for a graft was not possible. — Michael Cipriano