Medical devices maker Stimwave has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its StimQ peripheral nerve stimulator (PNS) system.
Claimed to be the first wireless and micro-technology neuromodulation device, the StimQ can allow ongoing full-body MRI scans under certain scanning conditions for the relief of chronic peripheral nerve pain.
StimQ is a smallest neuromodulation device, which can be placed in a minimally-invasive and 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.
According to Stimwave, the new system will help patients to avoid invasive surgical procedures or ongoing opioid treatments.
StimQ will provide pain relief by delivering small pulses of energy in a fully-selectable mode to electrodes placed at a peripheral nerve, helping the brain to remap specific pain signals.
The neuromodulation device is supported by a small and flexible wearable external unit.
Earlier, the company also secured FDA approval for the Freedom-8A/4A spinal cord stimulation (SCS) system.
It is also a full body MRI scan that uses the same technology specifically for back and leg pain based on placements in the spinal column region.
Stimwave chairman and CEO Laura Tyler Perryman said: “Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients reduce their chronic neuropathic pain by pinpointing stimulation directly to the affected peripheral nerves with a multi-electrode programmable device, which enables ongoing MRI scans.”
Stimwave is engaged in the development, manufacturing and commercialization of wirelessly powered and microtechnology neurostimulators.
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The US Food and Drug Administration.