Community Research and Development Information Service - CORDIS

FP5

REBEC NEUROMODULATIO Report Summary

Project ID: QLG5-CT-2001-00822
Funded under: FP5-LIFE QUALITY
Country: Germany

Hybrid Cuff Electrodes for recording afferent signals from peripheral nerves

Hybrid Cuff Electrodes for the stimulation and recording from the sacral nerves have been designed in a tripolar electrode arrangement in different diameters. This medical device were subjected to an intensive biocompatibility study according to the requirements of the ISO 10993 series and passed all tests of standards concerning biocompatibility testing of medical devices.

Based on the results of the series of biocompatibility tests performed on the raw materials and the ETO sterilized finished product, consequently no bioincompatibilites arising from the materials and the product can be expected during clinical application.

Documentations for clinical trial in humans have been prepared according ISO 14971:2000 and ISO 14155:2003 including risk analysis, clinical investigation plan and investigator brochure. Additionally in vivo tests in pigs showed the manageability and functionality of the Hybrid Cuff Electrodes.

Reported by

Fraunhofer Institut Biomedizinische Technik
Ensheimer Str. 48
66386 Sankt Ingbert
Germany
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