Nerve Repair Device Study Completed

Just completed is a two-year follow-up of a controlled, randomized, blind multi-center study of peripheral nerve repair using Integra LifeSciences Holding Corporation’s NeuraGen Nerve Guide. The Nerve Guide is a semi-permeable, resorbable Type 1 collagen tube designed for nerve repair. The study compared the NeuraGen Nerve Guide to direct suture in patients who had traumatic injuries to their median or ulnar nerves.

Thirty-two patients, who were routinely examined for sensory and motor electrophysiological function, post-operative pain assessments and overall hand function, completed the two-year post-operative period.

Results of the study showed that operation time using the collagen conduit was significantly shorter than was performing a conventional repair. 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 was as effective a method of joining severed nerves as was direct microsurgical suture.

Integra’s Chief Scientific Officer Simon Archibald said, “The successful completion of the NeuraGen Nerve Guide clinical trial is the culmination of over 30 years of basic science and clinical translation efforts by a wide range of industrial and academic collaborations across Europe and the United States. The clinical follow-up of nerve repair is a long and exacting task; the entire team is to be congratulated on completing this 10-plus year investigation.”

Michel Boeckstyns, M.D., and colleagues, presented the study titled A Collagen Conduit vs. Microsurgical Neurorrhaphy. Two-Year Follow up of a Prospective Blinded Clinical and Electrophysiological Multicenter RCT, at the Annual Meeting of the American Society for Surgery of the Hand in the Best Papers segment at the 68th Annual Meeting of the American Society for Surgery of the Hand, October 3-5, 2013, San Francisco, California.