Industry Insider

Integra to Launch DFU Matrix

Integra LifeSciences (Plainsboro, NJ), a global medical technology company, has announced the prepared launch of its Omnigraft™ Dermal Regeneration Matrix slated for June, pending receipt of final U.S. Food and Drug Administration (FDA) packaging approval.

The FDA gave premarket approval of a supplement for Integra Dermal Regeneration Template for the treatment of diabetic foot ulcers (DFUs) Jan. 7, based on results from the Foot Ulcer New Dermal Replacement (FOUNDER) Study. The published study, reportedly one of the largest to support treatment of DFUs, demonstrated that Omnigraft increases wound closure by 59%, increases the rate of wound size reduction by 50%, reduces the median time to wound closure by five weeks (over standard of care), and treats patients with fewer applications than other DFU therapies, according to Integra officials. Omnigraft is indicated for use in the treatment of partial- and full-thickness neuropathic DFUs that are > 6 weeks in duration with no capsule, tendon, or bone exposed when used in conjunction with standard diabetic ulcer care.

Integra has held medical education events at several leading industry conferences and conducted hands-on training over the last two months, officials said.

“We have already trained more than 175 healthcare professionals on the use of Omnigraft, and are dedicated to providing best-in-class hands-on and didactic training throughout the year,” said John Mahoney, vice president of professional affairs and medical education.

The FOUNDER Study provides the strong clinical evidence necessary to drive payer access for Omnigraft, officials said. More than 112 million covered lives have access to Omnigraft, through both private insurance and Medicare. Currently, 93% of Medicare patients in 47 states have access. Omnigraft may help to lower total cost of treatment, based on the clinical data, which demonstrated that among those patients who healed, 72% did so with one application and 92% with two applications or fewer.

“The results of the study were remarkable, and I see Omnigraft as a game changer in terms of not only quality of care, but also the economics of healthcare,” said Carl Van Gils, DPM, medical director of the wound clinic at Intermountain Healthcare’s Dixie Regional Medical Center, St. George, Utah, and a FOUNDER study participant. “I’m looking forward to the availability of Omnigraft as another treatment option for my patients’ hard-to-heal DFUs.”

NPUAP Adopts Use of ‘Pressure Injury’ Over ‘Pressure Ulcers’

Officials with the National Pressure Ulcer Advisory Panel (NPUAP) have announced the organization will, moving forward, use the term “pressure injury” — replacing “pressure ulcer” — for purposes of the staging system. The change in terminology more accurately describes pressure injuries to both intact and ulcerated skin, according to the NPUAP. In addition to the change in terminology, NPUAP will now use Arabic numbers in the names of the stages instead of Roman numerals. In the previous staging system, stage I (Stage 1, per NPUAP) and deep tissue injury described injured intact skin while other stages described open ulcers. This led to confusion because the definitions for each of the stages referred to the injuries as “pressure ulcers,” according to NPUAP. Additionally, the term “suspected” has been removed from the deep tissue injury diagnostic label. Additional pressure injury definitions include medical device-related pressure injury and mucosal membrane pressure Injury.

The updated staging definitions etc. were presented at a meeting of more than 400 professionals held in Chicago April 8-9. The stages were reportedly revised based on questions received by NPUAP from clinicians attempting to diagnose and identify the stage of pressure injuries. Schematic artwork for each of the stages of pressure injury was also revised and will be available for use at no cost through the NPUAP website. For more information, visit www.npuap.org/resources/educational-and-clinical-resources/pressure-injury-staging-illustrations.