A key advance is the sixty-day percutaneous system. A thin lead is placed through the skin, worn for up to sixty days, then pulled out. No permanent implant is left behind. The idea is that steady stimulation may reset the oversensitive circuit, not just mask the signal while the device runs.
Published prospective studies support lasting relief in a good share of patients after the lead comes out. The RESET trial met its primary endpoint (its main goal). More patients got at least fifty percent pain relief at three months than those getting standard interventional care. The evidence is younger and smaller than for spinal cord stimulation. We present it that way, not as settled.
Auricular vagal stimulation for diabetic peripheral neuropathy
For painful diabetic peripheral neuropathy we use the NS-100, a programmable peripheral electrical nerve stimulator made by Nalu. It is an FDA-cleared Class II device.
It is applied to the auricular branches — the nerve branches at the ear — not to the nerves in the painful limb. It acts as a vagal stimulator. That is the part patients find strange. The device sits at the ear, and the pain being treated is in the feet. It works through the vagal pathway and how that pathway shapes the way pain signals are handled. It does not block the painful nerve where it hurts.
The stimulator is worn for a set time — up to 30 days, though most patients are treated for around 20. Nothing is left permanently in place.
Placement is done under local anesthetic with no sedation. You drive yourself home, and there are no activity restrictions afterward.
On coverage. Peripheral nerve stimulation is a covered category under Medicare’s national coverage determination for electrical nerve stimulators, and local coverage determinations set the criteria that apply. That is the category, not a promise about your claim: your specific plan, indication and documentation still govern, so coverage is verified before anything is scheduled. An authorization, where one is obtained, is not itself a guarantee of payment.
See diabetic peripheral neuropathy for how the condition is evaluated before this point is reached.