StoryRegulatory
FDA expands WaveWriter Alpha spinal cord stimulators to painful diabetic neuropathy
Boston ScientificWaveWriter Alpha SCS
The FDA approved WaveWriter Alpha for leg and foot pain caused by diabetic nerve damage. It opens spinal cord stimulation to a large, fast-growing group of patients as a non-opioid option.
- About 37 million Americans have diabetes; roughly half will develop neuropathy.
- Includes a setting that relieves pain without the tingling older stimulators cause.
- Earlier approval (Dec 2020) covered chronic trunk and limb pain, including failed back surgery.