Radiation Testing of the GERD Stimulation Therapy System Using a Particle Accelerator

This testing was conducted to determine if exposure from a particle accelerator used to treat cancer patients would alter the performance of the EndoStim® neurostimulator when programmed either passively or actively and while being irradiated.

A total of 12 EndoStim Lower Esophageal Sphincter (LES) Stimulation System implantable neurostimulators were investigated in this research. Included were six each of the EndoStim I and EndoStim II. Half were used for passive testing, with the remaining half for active testing. Bremsstrahlung x-rays were delivered having a nominal energy of 18 MV at a rate of 6 Gy/min. A total dose of 80 Gy was achieved in testing minimally.

Monitoring of stimulation frequency, amplitude, pulse width, stimulation time, and voltage was conducted using software developed by EndoStim along with an oscilloscope. No observed changes to the intended stimulation were noted and all scheduled parameter magnitudes were achieved with device operation. All functional parameter changes were within ±10% from baseline.

EndoStim I and EndoStim II implant pulse generators appear to be immune to x-ray radiation from the particle accelerator at energies up to 18 MV, at dose rates of up to 6 Gy/min, and up to cumulative doses of minimally 80 Gy. As there were no observable effects on neurostimulation requirements, the EndoStim LES Stimulation System implantable neurostimulators are capable of withstanding direct radiation. The recommendations of the manufacturer should be followed further regarding the labeling requirements for insured safety to patients.