PLAINSBORO, N.J., April 27, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a arch all-around medical technology company, today appear that the Aggregation is able to barrage Omnigraft™ Dermal About-face Cast in June 2016, awaiting cancellation of final U.S. Food and Drug Administration (FDA) packaging approval.
The FDA accustomed the PMA Supplement for Integra® Dermal About-face Template (IDRT) for the analysis of diabetic bottom ulcers (DFUs) on January 7, 2016, based on after-effects from the FOot Abscess New DErmal Backup (FOUNDER) Study. The appear study, one of the better to abutment the analysis of DFUs, accustomed that Omnigraft increases anguish cease by 59%, increases the amount of anguish admeasurement abridgement by 50%, reduces the average time to anguish cease by bristles weeks, over accepted of care, and treats patients with beneath applications than added DFU therapies. Omnigraft is adumbrated for use in the analysis of fractional and full-thickness neuropathic DFUs that are greater than six weeks in duration, with no capsule, bond or cartilage exposed, back acclimated in affiliation with accepted diabetic abscess care.
Integra has captivated medical apprenticeship contest at several arch industry conferences and conducted hands-on training over the aftermost two months.
“We accept already accomplished added than 175 healthcare professionals on the use of Omnigraft, and are committed to accouterment best-in-class hands-on and academic training throughout the year,” said John Mahoney, Integra’s Vice President of Professional Affairs and Medical Education.
The FOUNDER Abstraction provides the able analytic affirmation all-important to drive payer admission for Omnigraft. Over 112 million covered lives accept admission to Omnigraft, through both clandestine allowance and Medicare. Currently, 93% of Medicare patients, in 47 states, accept access. Omnigraft may advice to lower absolute amount of treatment, based on the analytic data, which accustomed that of those patients who healed, 72% did so with one appliance and 92% with two applications or fewer.
Dr. Carl Van Gils, Medical Director of the Anguish Dispensary at Intermountain Healthcare’s Dixie Regional Medical Center, St. George, Utah, and a FOUNDER abstraction actor said, “The after-effects of the abstraction were remarkable, and I see Omnigraft as a bold banker in acceding of not alone affection of care, but additionally the economics of healthcare. I’m attractive avant-garde to the availability of Omnigraft as accession analysis advantage for my patients’ hard-to-heal DFUs.”
“Integra currently markets PriMatrix® Dermal Adjustment Scaffold, an acellular dermal matrix, in both the hospital and out-patient anguish dispensary ambience for the analysis of DFUs,” said Bill Weber, Integra’s Vice President and General Manager, Tissue Technologies. “In addition, we afresh appear an acceding to bazaar and advertise VolTAC™ antimicrobial anguish dressings, an avant-garde anguish affliction technology that can be acclimated to administer abiding and astute wounds. Once Omnigraft is launched, we will be in the different position to action clinicians a ample portfolio of anguish affliction solutions.”
About the FOUNDER Study The FOot Abscess New DErmal Backup (FOUNDER) Abstraction was a multi-center, randomized, controlled, alongside accumulation analytic balloon conducted beneath an Investigational Device Exemption (IDE). The cardinal analytic balloon enrolled 307 patients at 32 sites, and patients were monitored for up to 29 weeks. The primary endpoint of the abstraction was the accident of complete anguish cease at 16 weeks, as adjourned by the investigator. The accessory aftereffect measures included time to complete anguish closure, amount of anguish closure, accident of recurrence, and change in affection of activity metrics. The average cardinal of applications per patient, including the antecedent application, for the IDRT accumulation was one. The after-effects from the FOUNDER Abstraction were printed in the November/December affair of Wound Adjustment and Regeneration in the publication, “A analytic balloon of Integra Template for diabetic bottom abscess treatment.”
About Integra’s Anguish Affliction ProductsIntegra was founded on a technology belvedere to adjustment and change tissue with engineered collagen devices. In 1996, the FDA accustomed the Company’s aboriginal product, Integra® Dermal About-face Template, a collagen cast advised as a bark backup arrangement for the analysis of catechize burns. Integra Dermal About-face Template was the aboriginal artefact accustomed with a affirmation of about-face of dermal tissue. Integra’s bark and anguish articles additionally accommodate Integra® Meshed Bilayer Anguish Matrix, which can be acclimated with Negative Pressure Anguish Therapy; and Integra® Flowable Anguish Matrix, advised for accessible appliance to tunneled and/or debilitated wounds. Together, these articles represent over 30 years of science and accession in the development of collagen technology. Integra’s Ultra Pure Collagen™ is the abject absolute of implants acclimated auspiciously in over 12 actor procedures.
In July 2015, Integra acquired TEI Biosciences and TEI Medical, which added the SurgiMend® and PriMatrix® artefact curve to abode a cardinal of break in anguish affliction and tissue repair.
Integra® Dermal About-face Template is an avant-garde bark backup matrix, advised to accommodate absolute anguish cease and abiding about-face of the dermis. The artefact is placed in absolute acquaintance with the excised anguish and consists of a circuitous three-dimensional absorptive cast that acts as a arch for corpuscle clearing and allows for about-face of the dermal band of the patient’s skin.
About IntegraIntegra LifeSciences, a apple baton in medical technology, is committed to attached ambiguity for clinicians, so they can apply on accouterment the best accommodating care. Integra offers avant-garde solutions, including arch artificial and adorning technologies, in specialty surgical solutions, orthopedics and tissue technologies. For added information, amuse appointment www.integralife.com.
This account absolution contains advanced statements aural the acceptation of the Clandestine Securities Litigation Reform Act of 1995. Advanced statements include, but are not bound to, statements apropos the articles and casework provided by Integra. Such avant-garde attractive statements absorb risks and uncertainties that could account absolute after-effects to alter materially from predicted or accepted results. Among added things, the alertness of surgical professionals to use Integra articles may affect the affairs for their use in surgical procedures. In addition, the economic, competitive, governmental, abstruse and added factors, articular beneath the branch “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year concluded December 31, 2015 and advice independent in consecutive filings with the Securities and Exchange Commission could affect absolute results.
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