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News From the Food and Drug Administration
June 16, 2015

Pain Relief Without Paresthesia

JAMA. 2015;313(23):2312. doi:10.1001/jama.2015.6326

Patients with chronic, intractable low back or leg pain have a new option for pain relief from an electrical stimulation device that doesn’t cause paresthesia. The Senza System, which delivers high-frequency stimulation, received FDA approval in early May.

“The FDA has approved several other totally implanted spinal cord stimulators for pain reduction, but this system is unique because it delivers a high-frequency output of 10 kHz that does not cause a tingling sensation—called paresthesia—in patients,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, said in a statement (http://1.usa.gov/1JwKgtt).