Integra LifeSciences Holdings Corporation, a leader in medical technology, 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.
"Integra is pleased to announce the approval of IDRT for the treatment of diabetic foot ulcers. This approval allows us to provide clinicians and their patients with a product backed by a robust clinical trial to treat the nearly 1 million non-healing DFUs that will occur this year. This significant milestone enables us to remain on track for DFU market commercialization in mid-2016," said Peter Arduini, Integra's president and chief executive officer.
The prevalence of diabetes continues to rise, currently affecting an estimated 30 million people in the United States. Of those diagnosed, as many as 15% may experience a diabetic foot ulcer in their lifetime. The advanced active healing dressings market is approximately $3.0 billion in the US, of which nearly $600 million is in cellular and tissue-based products (CTPs).
"The new indication for IDRT, supported by clinical evidence, will benefit clinicians and their patients. This product has been used in the operating room to treat life-threatening third-degree burns since 1996, and can now be used in the clinic to treat patients who suffer from diabetic foot ulcers," said FOUNDER Study Principle Investigator Dr. Lawrence A. Lavery, DPM, MPH of University of Texas Southwestern Medical Center.
The FOot Ulcer New DErmal Replacement (FOUNDER) Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The pivotal clinical trial enrolled 307 patients at 32 sites, and patients were followed for up to 29 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks. The secondary outcome measures included time to complete wound closure, incidence of recurrence, and quality of life. The median number of applications per patient, including the initial application, for the IDRT group was one. The results from the FOUNDER Study were printed in the November/December issue of Wound Repair and Regeneration in the publication, "A Clinical Trial of Integra Template for Diabetic Foot Ulcer Treatment."
Integra was founded on a technology platform to repair and regenerate tissue with engineered collagen devices. In 1996, the FDA approved the company's first product, Integra Dermal Regeneration Template, a collagen matrix designed as a skin replacement system for the treatment of third-degree burns. Integra Dermal Regeneration Template was the first product approved with a claim of regeneration of dermal tissue.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for caregivers, so they can concentrate on providing the best patient care.