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FDA approved spinal cord stimulators for chronic back pain

On May 16, 2023, the US Food and Drug Administration (FDA) approved spinal cord stimulation (SCS) devices from the pharmaceutical company Abbott for the treatment of chronic back pain in people who have not had or are not eligible for receiving back surgery, per a press release from Abbott. The approval was granted after a six-month study of 200 participants showed spinal cord stimulation provided significant relief and improvements in pain, function, quality of life and mental health.

Those enrolled in the study had experienced an average of nearly 13 years of disabling chronic back pain. Participants were ineligible for corrective back operations because they were medically frail or had numerous degenerative changes in their spine, none of which were severe enough to qualify for corrective surgery but still caused significant symptoms.

After six months, 85 percent of those implanted with Abbotts SCS devices achieved a significant reduction in back pain, compared with only 7 percent who received conservative medical management. On average, people who received SCS therapy experienced about a 70% reduction in pain.

Historically, people who have no options for corrective surgery to address their chronic back pain are typically treated with combination therapies: physical therapy and chiropractic care, injections and pain relievers, says Allen Burton, MD, division vice president and chief medical officer. of Abbott’s neuromodulation activity. However, these options are not effective for a significant subset of people who previously lacked other therapies, making the treatment pathway complicated and uncertain for others. People who suffer from chronic back pain and don’t meet typical surgical criteria tend to forgo future care, eventually resigning themselves to living with chronic debilitating pain.

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