FDA expands indication for spinal cord stimulation system to cover nonsurgical back pain
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The FDA has approved an expanded indication of Boston Scientific’s spinal cord stimulation system that treats painful diabetic peripheral neuropathy, a complication of diabetes that often affects the lower extremities.
According to a release from Boston Scientific, the WaveWriter Alpha Spinal Cord Stimulator Systems, a non-opioid treatment, provides therapeutic pain relief by emitting mild electric pulses to the spinal cord that interrupt pain signals traveling to the brain. The latest approval by the FDA expands the indications to include diabetic peripheral neuropathy of the lower extremities for paresthesia-based stimulation.
The WaveWriter Alpha SCS Systems was approved by the FDA in December 2020 to manage chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome types I and II, as well as intractable low back pain and leg pain.
“The use of SCS to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world,” Jim Cassidy, president of neuromodulation at Boston Scientific, said in the release. This expanded indication is another testament to our commitment to delivering a robust portfolio of
interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.”
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