# Toward translation of flexSTIM: a biomimetic implanted pattern generator for effective long-term pressure injury prevention through automatedweight shifting and enhanced tissue health.

> **NIH VA IU1** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2024 · —

## Abstract

Pressure injury (PrI) prevention remains a major challenge over the long term for Veterans with impaired
mobility, in particular those with spinal cord injury (SCI). PrI limit activities of daily living, often leading to
prolonged bedrest, hospitalization and even death. Clinical practice guidelines recommend weight-shifting
every 20 minutes for persons with SCI, which is impractical when busy with activities of daily living. We have
previously shown that long term use of dynamic gluteal intermittent stimulation (iGSTIM) using percutaneous
electrodes and an external stimulator effectively provides an extra means of weight shifting, improves local
blood flow, increases muscle size and reduces the incidence of tissue breakdown, specifically pressure
injuries. User feedback was that long-term use of iGSTIM meant they no longer worried about recurrent skin
problems requiring significant periods of bedrest. Furthermore, daily use of the system was easy and fit well in
to their activities of daily living. However, continued usage is necessary to sustain improvements in tissue
health and the need to keep percutaneous lead exit sites covered and regularly cleaned became arduous over
time. Users requested a fully implanted iGSTIM for regular weight shifting and PrI prevention.
Our team has been contacted many times over the years by individuals asking for a system that could be
entirely implanted. Other prevention methods these individuals tried have failed and they are desperate for a
new alternative. We have therefore developed the flexSTIM biomimetic implantable pulse generator (IPG).
Prior funding synergized recent advances in flexible hybrid electronics, additive manufacturing and packaging
with our prior clinical findings to provide initial development and testing of the flexSTIM IPG laying the
foundation for translation and clinical implementation in persons with SCI. Combined with industry-standard
intramuscular electrodes, the VA-patented flexSTIM IPG is a novel technology that proactively addresses the
issues of decreased muscle quality and the long-term need for regular weight-shifting for persons with limited
mobility, in particular Veterans with SCI. This small flexible 2-4 channel system meets the end user need for
straightforward automated weight-shifting and can be initiated daily at the touch of a button. flexSTIM is
designed to be inserted into a subcutaneous pocket through a 1” incision, with the whole iGSTIM system
implemented as an outpatient procedure.
The overall goal of this TRRA-1 planning grant is to complete review of technical merit of the research
completed to date together with evaluating the further testing proposed, in order to assemble the detailed
documentation necessary for a pre-IDE (Q-Sub) meeting with the FDA on the iGSTIM system including
implanted flexSTIM Class III IPG and intramuscular electrodes with an external (primary) coil. Specific activities
will include: Management of regulatory tasks including regulatory ...

## Key facts

- **NIH application ID:** 10864214
- **Project number:** 1IU1RX005078-01
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** KATH BOGIE
- **Activity code:** IU1 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2023-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10864214

## Citation

> US National Institutes of Health, RePORTER application 10864214, Toward translation of flexSTIM: a biomimetic implanted pattern generator for effective long-term pressure injury prevention through automatedweight shifting and enhanced tissue health. (1IU1RX005078-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10864214. Licensed CC0.

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