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Extracorporeal Magnetic Innervation
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FDA Clearance
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As part of the FDA Clearance process in 1998, a study was conducted to demonstrate broad equivalence between magnetic stimulation and electrical stimulation by comparing the ability of the two devices to produce contractions of the pelvic floor musculature. The study involved measuring urethral pressures and electromyographic (EMG) activity of the peri-urethral muscles in healthy volunteers during electrical stimulation and during magnetic stimulation. Recordings were made in the same subject with the body at rest, with electrical stimulation, and with magnetic stimulation. All patients had stimulation with both electrical stimulation and magnetic stimulation. The study found that contractions produced by both electrical and magnetic simulation were both visual and palpable in all ten patients. In all cases, the magnitude of the sphincter EMG activity produced by magnetic stimulation was greater than that produced by electrical stimulation. Here is a sample of the EMG recordings of muscle contractions generated during this study.

A full copy of the study is available from the company upon request.

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