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StimQ PNS System Receives FDA Clearance

PharmaLive news release; 2017 Aug 9

Stimwave LLC has received 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. Designed for people who suffer from severe intractable chronic pain, the StimQ Peripheral Nerve Stimulator (PNS) System offers an alternative for those who do not want to rely on invasive surgical procedures or ongoing opioid treatments. Stimwave LLC is headquartered in Pompano Beach, FL.

Indications: The device, which is less than 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.

Administration: The StimQ device can be used 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 recent FDA clearance enables the pain sufferer to have frequent and necessary MRI scans of any part of their body without removing the implant.

Citation:

Stimwave receives FDA 510(k) clearance for the first full-body MRI scan ready wireless peripheral nerve stimulator (PNS) system. [news release]. Pompano Beach, Florida. August 9, 2017. http://www.pharmalive.com/stimwave-receives-fda-510k-clearance-for-the-f.... Accessed August 15, 2017.