The FDA has cleared Nevro's Senza spinal cord stimulator system for the treatment of chronic pain associated with painful diabetic neuropathy.
Senza is the only FDA-approved spinal cord stimulator with a specific indication to treat with painful diabetic neuropathy. The approval is specific to Nevro's 10 kHz high-frequency therapy, according to a July 19 news release.
The system could allow painful diabetic neuropathy patients to discontinue long-term drug therapy and avoid "unwanted drug side effects," said Frances Broyles, MD, medical director of diabetes/endocrinology and nutrition at Swedish Health Services in Seattle.
Nevro Chair, CEO and President Keith Grossman, MD, said he expects the new indication to be an "important driver of the long-term growth of our business for years to come."
The company has initiated a commercial launch of the device.