PLAINSBORO, N.J., Dec. 12, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the publication of the clinical study, Collagen Conduit Versus Microsurgical Neurorraphy: 2-Year Follow Up of a Prospective, Blinded Clinical and Electrophysiological Multicenter Randomized, Controlled Trial, in the December issue of The Journal of Hand Surgery.
The study provides two-year follow up of a controlled, randomized, blind multi-center study of peripheral nerve repair, comparing NeuraGen® Nerve Guide to the conventional method of direct suture repair in patients who had complete traumatic nerve injuries to the median and/or ulnar nerves. Thirty-two patients completed the two-year post-operative follow-up period, during which they were routinely examined for sensory and motor electrophysiological function, post-operative pain assessments and overall hand function.
Results showed that operation time using the collagen conduit was 40% less than performing direct suture repair, and patients who received NeuraGen Nerve Guide had lower post-operative pain than those treated with direct repair. The study concluded that entubulation nerve repair using the NeuraGen Nerve Guide is as effective a method of repairing mixed motor and sensory nerves as direct microsurgical suture.
"Demonstrating the equivalent effectiveness of clinical entubulation repair of the major nerves of the forearm compared to the "gold standard" of microsurgical repair is a significant milestone for this technology," said Simon Archibald, Integra's Chief Scientific Officer. "This is the first report in the literature of a prospective, randomized, controlled study of functional recovery following the repair of major mixed motor and sensory nerves, using an approved and commercially available nerve conduit. We hope that this new information will aid the expansion and further adoption of the technique."
About NeuraGen Nerve Guide
NeuraGen Nerve Guide is a semi-permeable, absorbable Type 1 collagen tube implant, designed for peripheral nerve repair. It was engineered with a specific pore size, allowing for nutrient diffusion and retention of representative Nerve Growth Factor, and provides a protective environment for axonal growth and nerve regeneration across a nerve gap. The NeuraGen Nerve Guide development included years of extensive scientific and preclinical research, prior to receiving 510 (k) clearance from the U.S. Food and Drug Administration (FDA) in 2001, and CE Mark from the European Union in 2003. To date, the Company estimates that over 60,000 NeuraGen Nerve Guides have been implanted, worldwide.
About Integra LifeSciences
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source:Integra LifeSciences Holdings Corp.