FDA Approves New Device to Treat Chronic Pain

The FDA has approved the Senza spinal cord stimulation (SCS) system (Senza System), an aid for the treatment of chronic intractable pain of the trunk and/and or limbs.

The system is meant to help manage pain in those with failed back surgery syndrome, low back pain, and leg pain.

“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,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.
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“Since some patients don’t like the parenthesis associated with traditional SCS, this device offers another treatment option,” he explained.

Once a physician determines the need for stimulation based on a patient’s symptoms—and after receiving Senza System treatment for a 1 to 2 week simulation using an implanted lead and model of the stimulus generator that is worn outside the body—the SCS system is implanted through a minimally invasive surgical procedure.

The thoracolumbar area of the spinal cords receives electrical stimulation through leads connected to a rechargeable pulse generator that is implanted in the upper buttocks region or abdomen. Patients can control the pulse generator using a remote.

To determine the efficacy and safety of the device, a clinical study was conducted including 198 participants with chronic intractable pain. The participants received either the Senza System or another FDA-approved device that deleiered 2 to 1,200 Hz of stimulation and produced parenthesia.

The study showed that 75% of participants using the Senza System experienced a 50% decrease in pain after 3 months and a 55% decrease by 12 months.

The most common adverse events associated with using the Senza System included dislocation of the device lead under the skin and pain at the implant site.

-Michelle Canales Butcher

Reference:

FDA. FDA approves spinal cord stimulation system that treats pain without tingling sensation. May 8, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm446354.htm. Accessed May 11, 2015.