Biosafety Assessment of an Intra-Neural Electrode (TIME) following Sub-Chronic Implantation in the Median Nerve of Göttingen Minipigs
Abstract
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.
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In a study of TIME implantation in the median nerve of pigs during a 38-day follow up, there was no necrosis, formation of fibrotic capsule was limited, and all electrodes were stable.
“A different study evaluated the outcomes of TIME implantation in the median nerve of pigs during a follow up of 38 days. There was no necrosis, the formation of fibrotic capsule was limited, and all the electrodes were stable [189].”
From Interfaces with the peripheral nervous system for the control of a neuroprosthetic limb: a review (2020) · cites this paper as [189]
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- Authors
- Kundu, A., Wirenfeldt, M., Harreby, K. R., & Jensen, W.
- Affiliations
- Aalborg University (DK)
- Aalborg University Hospital (DK)
- Corresponding author
- Kundu, Aritra
- Venue
- The International Journal of Artificial Organs
- Publisher
- SAGE Publications
- Published
- 2014-06
- Volume
- 37
- Issue
- 6
- Pages
- 466-476
- ISSN
- 0391-3988 (ISSN-L)
- 1724-6040
- OpenAlex
- W2123405986
- Cited by
- 15
- References
- 29
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 2 · 2021: 1 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 3 · 2016: 1 · 2014: 1
- FWCI
- 0.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The International Journal of Artificial Organs (publishedVersion)
- PubMed (publishedVersion)
- VBN Forskningsportal (Aalborg Universitet) (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Nerve injury and regeneration
- Keywords
- peripheral nerve interfaces, neural prosthesis, biocompatibility, biosafety, median nerve, nerve fibrosis, fibroblasts, inflammation, necrosis, Göttingen minipig
- MeSH terms
- Animals, Electrodes, Implanted, Equipment Design, Equipment Safety, Median Nerve, Swine, Swine, Miniature, Equipment Failure Analysis, Neural Prostheses
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