NIH Reporter #1IU1RD000665-01A2

Translation of flexSTIM: a biomimetic implanted pattern generator for effective long-term pressure injury prevention through automated weightshifting and enhanced tissue health.

This award supports the development and preclinical testing of the flexSTIM implantable device to prevent pressure injuries in Veterans with spinal cord injury by enabling automated weight-shifting.

Description

The project involves the development and preclinical testing of the flexSTIM biomimetic implantable pattern generator (IPG), a fully implantable system designed to support automated weight-shifting and pressure injury prevention in Veterans with spinal cord injury (SCI). Objectives include completing all pre-clinical testing required for full Investigational Device Exemption (IDE), conducting benchtop and GLP biocompatibility testing to ISO 10993 standards, performing long-term in-vivo testing for function, reliability, and safety, and submitting full IDE for early feasibility study in 10 Veterans with SCI.

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