Sprint Nerve Stimulator Gains Broader Indication

FDA has cleared an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation (PNS) System. The device’s previous clearance limited its use to the back and extremities, but the new indication allows it to also be used in areas of the head, neck, and the front of the torso, according to the company. “The clearance was based on real world safety data collected from over 5,500 patients using the Sprint PNS System commercially, both on-label and off-label,” it says.

SPR says its Sprint neuromodulation system provides a 60-day treatment to “recondition” the central nervous system to provide significant and sustained relief from chronic pain without a permanent implant, nerve destruction or addiction risk. “The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain,” it says. It is not intended to treat pain in the region innervated by the cranial and facial nerves.