MedCity News is reporting that SPR Therapeutics of Cleveland, Ohio is close to receiving FDA regulatory approval for its SMARTPATCH Peripheral Nerve Stimulation System aimed at treating shoulder pain in patients post stroke. The device utilizes percutaneous leads to stimulate muscle activity and in turn reduce pain.
From MedCity News:
Clinical trials have shown that the device works, and SPR has submitted a 510(k) application to the U.S. Food and Drug Administration that, if approved, would clear the company to begin selling the device.
Additionally, SPR will pursue regulatory clearance for more clinical indications, such as general shoulder pain and lower back pain. A fully implantable version of the device, which will require following the FDA’s more onerous and lengthy Premarket Approval Application process, is planned for commercialization in about five years.
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Product page: SMARTPATCH…