FDA approves Integra's skin regeneration system to treat diabetic foot ulcers

The FDA expanded the indication of Integra's Omnigraft Dermal Regeneration Template via a PMA supplement approval, enabling it to be used to treat certain diabetic foot ulcers, a condition that leads to 50,000 amputations per year. The condition afflicts about a quarter of the 29 million Americans who have diabetes. Made of silicone, cow collagen, and shark cartilage, the Dermal Regeneration Template is placed over the ulcer to encourage new skin and tissue to regenerate and heal the wound, the agency says. "We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal," said Dr. William Maisel, the acting director of the FDA's device arm (CRDH). "Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities." The Dermal Regeneration Template was previously approved for treating life threatening burn injuries and burn scars when the use of a patient's own skin for a graft is not possible. More from FDA | Here's the company's release (PDF)