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Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review
Lizbeth A Leapo1, Michael E Miller2, Harry A Hoyen3
1Case Western Reserve University, Cleveland, OH, USA.
Summary
Neuroprosthetic devices for lower extremity function show good long-term survival rates. While malfunction rates are comparable to other implants, infection rates are slightly higher, necessitating future prevention strategies.
Area of Science:
- Biomedical Engineering
- Neuroscience
- Rehabilitation Medicine
Background:
- Neuroprosthetic devices offer functional restoration for individuals with paralysis due to central nervous system disorders.
- Implanted pulse generators aim to improve quality of life by restoring motor function in lower extremities.
Purpose of the Study:
- To analyze the 25-year outcomes of implanted pulse generators in volunteers with paralysis.
- To determine device survival rates, common malfunctions, and reasons for explantation.
- To identify factors influencing neuroprosthetic device performance.
Main Methods:
- Retrospective review of implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12, IST-16) device histories from 1996-2021.
- Analysis of surgical notes, regulatory documentation, and manufacturing records.
- Kaplan-Meier analysis for device survival and technical malfunction rates.
Main Results:
- 64.6% of 65 implanted devices remain operational.
- Explantation reasons included infection (7), internal failures (7), and external damage (6).
- Device survival rates at 5, 10, and 20 years were 92%, 84%, and 71%, respectively. Pooled infection rate was 5.4%.
Conclusions:
- Malfunction incidence aligns with other implanted medical devices; infection rates are slightly elevated.
- Future research should prioritize infection prevention and technique modification based on patient factors.
- Integrating experience from other motor neuroprosthesis applications is recommended.
