US FDA clears Stimwave’s full-body MRI-ready wireless peripheral nerve stimulator

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Stimwave has received US Food and Drug Administration (FDA) 510(k) clearance for the first wireless, micro-technology neuromodulation device that can enable ongoing full-body MRI scans under certain scanning conditions for the relief of chronic peripheral nerve pain.

The StimQ Peripheral Nerve Stimulator (PNS) System is intended to offer an alternative for those who do not want to rely on invasive surgical procedures or ongoing opioid treatments. The smallest neuromodulation device available, StimQ can be placed in a minimally-invasive, outpatient procedure for the treatment of various pain syndromes, including, but not limited to: shoulder pain, upper extremity neuropathy, mid and lower back pain, and lower extremity neuropathy. The new FDA clearance enables the pain sufferer to have frequent and necessary MRI scans of any part of their body without removing the implant.

“This is great news for many chronic pain patients who previously did not have a minimally-invasive implant option available for peripheral nerve-related pain and will continue to require frequent MRI scans throughout their body for management of their pain and monitoring of their current and future medical needs,” says Konstantin Slavin, professor of neurosurgery at University of Illinois at Chicago, Chicago, USA. “While PNS has been shown in literature to be an effective treatment, for many years device placement has been difficult due to the bulk and length of cables, connectors and pulse generators needed to stimulate a small nerve target. This miniature wireless peripheral nerve stimulator that minimises the need for surgery in patients who are already suffering from pain, while allowing on-going care with full body MRI scan capabilities may provide a viable, non-opioid option for long-term pain management.”

The device, which is >5% of the size of other standard implanted options, 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 and comfortable wearable external unit. The company previously received FDA clearance for the Freedom-8A/4A Spinal Cord Stimulation (SCS) System, which is also full body MRI scan-cleared and utilises the same technology specifically for back and leg pain based on placements in the spinal column region.

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