Nevro announced that the Food and Drug Administration (FDA) has approved the Senza System, a spinal cord stimulation (SCS) system as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain.

The Senza System delivers Nevro’s proprietary HF10 therapy that can reduce pain by providing high frequency stimulation (at 10kHz) and low stimulation amplitudes without producing paresthesia. Electrical impulses are sent to the thoracolumbar area of the spinal cord for pain relief via small electrodes on leads that are placed near the spinal cord and connected to a compact, battery-powered generator implanted under the skin.

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Prior to receiving treatment with the Senza System, patients participate in a 1–2 week simulation using an implanted trial lead and a model of the stimulus generator worn outside the body. If the clinician determines that the stimulation performs well based on the patient’s symptom reports, the system is implanted via a minimally invasive surgical procedure. A clinician initially programs the device and patients can use a remote to control the pulse generator within the output ranges programmed by the clinician.

The FDA approval was based on a review of the safety and efficacy of the Senza System from a clinical study in which 198 patients with chronic intractable pain of the trunk and/or limbs were randomized to the Senza System or treatment with another FDA-approved device that delivers stimulation in the 2–1,200Hz frequency range that produced paresthesia. For the patients using the Senza System, 75% achieved a 50% reduction in pain from baseline at 3 months and 55% at 12 months. No stimulation-related neurological deficits were observed for either treatment group.

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