Integra LifeSciences Holdings Corporation announced that the United States Food and Drug Administration (FDA) has approved the PMA Supplement for Integra® Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFU). The approval of this new indication is based on results from the FOUNDER (FOot Ulcer New DErmal Replacement) Study, a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The FOUNDER Study showed that patients treated with IDRT demonstrated a 59% improvement in the incidence of complete wound closure compared to standard of care.

IDRT, with its newly approved DFU indication, will be marketed under the name Integra® Omnigraft™ Dermal Regeneration Template.