A new neuromodulation device—billed as the smallest available—can be used to relieve chronic peripheral nerve pain in patients who can undergo MRI scans while the device remains in their bodies.
The StimQ Peripheral Nerve Stimulator (Stimwave LLC) has received FDA 510(k) clearance as the first wireless, microtechnology neuromodulation device that can enable ongoing full-body MRI scans under certain scanning conditions.
More than 400 million people worldwide suffer from severe intractable chronic pain. The StimQ Peripheral Nerve Stimulator System offers an alternative for those who do not want to rely on invasive surgical procedures or ongoing opioid treatments.
The device can be placed in a minimally-invasive, outpatient procedure for the treatment of various pain syndromes, such as shoulder pain, upper extremity neuropathy, mid and lower back pain, and lower extremity neuropathy. The new FDA clearance enables pain sufferers to have frequent and necessary MRI scans of any part of their bodies without removing the implant.
While studies have shown peripheral nerve stimulation (PNS) to be effective, device placement has been difficult due to the bulk and length of cables, connectors, and pulse generators needed to stimulate a small nerve target. Stimwave says its new device is less than 5% of the size of other standard implanted options.
The multi-electrode programmable device provides pain relief by delivering small pulses of energy in a fully-selectable manner to electrodes placed at a peripheral nerve enabling the brain to remap specific pain signals. The implant is powered by a small, flexible, wearable external unit. The company previously received FDA clearance for the Freedom-8A/4A Spinal Cord Stimulation (SCS) System, which is also cleared for full body MRI scans and utilizes the same technology specifically for back and leg pain based on placements in the spinal column region.
Source: Stimwave LLC; August 9, 2017.