FDA clears Integra's collagen nerve guide:
This article was originally published in Clinica
Integra LifeSciences (Plainsboro, New Jersey) has received US FDA 510(k) clearance to market its absorbable implant for repairing severed peripheral nerves in the extremities. The NeuraGen nerve guide consists of a collagen tube that provides both a protective environment for the regenerating nerve and a conduit through which regenerating axons can bridge an injury. The firm plans to launch the product through its Integra NeuroSciences division later this year. It also intends to CE-mark the device for sale in Europe and is working with its partner, Century Medical, to gain market approval in Japan.