Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that the results of the multi-center human clinical trial comparing NeuraGen® Nerve Guide with direct suture repair have been accepted, in abstract form, for presentation at the joint meeting of the American Association for Hand Surgery (AAHS), American Society for Reconstructive Microsurgery (ASRM), and American Society for Peripheral Nerve (ASPN), January 12-18, 2011, Cancun Mexico.
The clinical trial was a controlled, randomized, blind, parallel group, multi-center study of peripheral nerve repair comparing NeuraGen® Nerve Guide to direct suture in patients who had complete traumatic nerve injuries to the median and/or ulnar nerves. Thirty-two (32) patients completed the 2-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 patients who received NeuraGen® Nerve Guide had lower post-operative pain than those treated with direct suture repair. The overall study conclusion was that entubulation nerve repair using the NeuraGen® Nerve Guide is as effective a method of joining severed nerves as direct microsurgical suture or short gap graft repair.
Dr. Christian Krarup, Director of the Department of Clinical Neurophysiology at the Rigshospitalet, Copenhagen University Hospital, was the Principal Investigator of the study that was conducted in Denmark and Spain. Dr. Krarup commented, "This study shows that repair with NeuraGen® Nerve Guide is a realistic alternative to conventional end-to-end or graft repair."
Dr. Simon Archibald, Integra's Chief Scientific Officer, stated, "The conclusion to the NeuraGen® Nerve Guide trial is the culmination of over 30 years of basic science and clinical translation efforts that have involved a wide range of industrial and academic collaborations across Europe and the United States. The clinical follow-up of repaired nerve lesions is a long and exacting task; the entire clinical team is to be congratulated on completing this 10+ year investigation. Integra is extremely pleased to have completed the study successfully, and of having been given the opportunity to present the results for the first time at the prestigious international forum provided by the AAHS."
Stuart Essig, Integra's CEO and President, stated, "We are honored to be working with such highly-respected and innovative clinicians and scientists. This study reinforces Integra's commitment to surgeons and their patients, as well as our position as an innovation leader in the field of regenerative medicine."
NeuraGen® Nerve Guide, launched in the U.S. in 2001, is a highly purified, type 1 collagen conduit used in peripheral nerve repair. It is sold by Integra's Extremity Reconstruction sales organization, which focuses on lower extremity reconstruction, upper extremity reconstruction, tendon protection/augmentation, peripheral nerve repair/protection, and wound repair.
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