HealthDay News — The FDA approved the Senza spinal cord stimulation system to treat chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery, low back pain, and leg pain. The device can reduce pain without the paresthesia that often characterizes more traditional pain-relieving methods.
The implanted device uses high-frequency stimulation to avoid paresthesia, the agency said in the news release. Before treatment with Senza begins, potential users are treated with a trial system for a week or two, the FDA said. Once a physician determines that the trial device has worked, patients have minimally invasive surgery to implant Senza in the upper buttocks or abdomen. The device includes a patient-operated remote control.
Senza’s safety and effectiveness were clinically evaluated in a study involving nearly 200 people. Three-quarters of those treated with Senza reported pain reduction of about 50%, the FDA said. The most common adverse reactions included pain at the implant site and dislocation of the device lead after implantation.
“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,” 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. “Since some patients don’t like the paresthesia associated with traditional spinal cord stimulation, this device offers another treatment option.”
The system is manufactured by Nevro Corp., based in Menlo, Calif.
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