Integra LifeSciences Holdings Corporation says it has received approval from the U.S. FDA for the packaging of its new product, Integra® Omnigraft™ Dermal Regeneration Matrix, which clears the way for its commercial release. The product’s unique packaging is designed for ease of handling and application in the outpatient wound care setting.
Omnigraft is indicated for use in the treatment of partial and full-thickness neuropathic diabetic foot ulcers (DFUs) that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
The FDA approved the PMA Supplement for Integra® Dermal Regeneration Template (IDRT), also marketed as Integra Omnigraft Dermal Regeneration Matrix, for the treatment of DFUs on January 7, 2016, based on results from the FOUNDER study. The published study, one of the largest to support the treatment of DFUs, demonstrated that, compared to conventional therapy, Omnigraft increases the incidence of wound closure by 59%, increases the average rate of wound size closure by 50%, and reduces the median time to wound closure by five weeks. Compared to other DFU therapies, Omnigraft healed patients with fewer applications, with 92% of those who healed requiring two applications or fewer.
“Over 30 million people in the United States are impacted by diabetes, and the numbers are growing. Of these, almost 1 million have hard-to-heal diabetic foot ulcers, which require treatment with advanced wound care solutions,” said Peter Arduini, Integra’s President and CEO. “We are extremely pleased that we can now offer clinicians a differentiated treatment solution for their patients’ DFUs. We believe Omnigraft is a great fit for the evolving healthcare environment, and will help improve the quality of life for patients and their families.”
“This is a very exciting opportunity for Integra,” said Mark Augusti, President of Integra’s Orthopedics & Tissue Technologies division. “We have a dedicated wound care sales team, and have already educated over 175 health care professionals on the use of Omnigraft. We have also created www.omnigraft.com, for clinicians, patients and payers to learn more about this new product. With Omnigraft, we hope to solve the needs of diabetics by closing their hard-to-heal DFUs.”
Source: Globe Newswire