Biosafety assessment of an intra-neural electrode (TIME) following sub-chronic implantation in the median nerve of Göttingen minipigs.

Before a novel peripheral nerve interface can be applied in a neural prosthesis for human use, it is important to determine the biocompatibility of the device. The aim of the present study was to assess the biosafety of the recently developed transverse intrafascicular multi-channel electrode (TIME) in a large nerve animal model. Six TIMEs were implanted (33-38 days) into the median nerves of Göttingen minipigs, and nerve specimens were harvested for histological analysis. We analyzed samples from the area of the implant and from control regions. We found an expected layer of fibrosis around the implant and fibroblasts in both the implant and control region, however, we found no significant presence of inflammatory cells or necrosis. Our results indicated that the TIME may be an attractive, biocompatible neural interface for future neuroprosthesis applications in the clinic setting.