Stimwave announced today that its StimQ Peripheral Nerve Stimulator System has been cleared by the FDA for use during full-body MR exams under certain scanning conditions.

“This device can be used in the MRI because of its size and the passive nature of the implant,” Laura Perryman, CEO of Stimwave, told HCB News. “It is powered from outside the body wirelessly, so there is no battery and there are no long wires in the body that can cause issues with MRIs.”

The StimQ PNS System is implanted with a minimally-invasive, outpatient procedure and treats pain syndromes including shoulder pain, upper extremity neuropathy, mid and lower back pain and lower extremity neuropathy. It’s an alternative for patients who don’t want to undergo invasive surgical procedures or continuous opioid treatments.
These patients are now able to receive MR scans of any part of their body without having to remove the implant. Patients with peripheral nerve-related pain continue to require frequent MR scans through their body to manage their pain and monitor their current and future medical needs.

“Our stimulator is the [only] one that can be used at those locations and still enable the scans to be done,” she added. “If you get another product [off-label] you will never be able to have the MRI of that body part again.”

Studies have shown that PNS is an effective treatment, but previous devices were difficult to implant. They were bulky, had long cables and connectors and pulse generators were needed to stimulate a small nerve target.

The StimQ PNS System is less than five percent the size of other standard implanted options and is powered by a small, flexible wearable external unit. It provides pain relief by delivering small pulses of energy to electrodes that are placed at a peripheral nerve, which allows the brain to remap specific pain signals.

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