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The FDA approved the first (PDN), Nevro Corp announced on Monday.

The device, the only such treatment approved by the agency for this specific indication, delivers high-frequency stimulation (10 kHz frequency, 30 μs pulse width delivered via bipole, with an amplitude range of 0.5 to 3.5 mA) to the spinal cord. Two percutaneous leads are placed epidurally and connected to the pulse generator, and stimulation can be adjusted according to patient feedback.

"Diabetic neuropathy is one of the most prevalent and debilitating, chronic complications of diabetes, and for years, PDN patients have struggled with a lack of effective treatment options when conventional medications fail or are not tolerated," commented Frances Broyles, MD, medical director of Diabetes/Endocrinology and Nutrition at Swedish Health Services in Seattle, in a statement.

"The ability to now offer Nevro's proven 10 kHz Therapy, which may enable discontinuation of long-term drug therapy and eliminate unwanted drug side effects, is a welcome addition as a treatment option for my PDN patients dealing with this challenging condition," she added.

The approval comes based on the 6-month SENZA-PDN randomized controlled trial, presented earlier this year at the American Association of Clinical Endocrinology virtual meeting.

Among the 216 participants with diabetes, those who were treated with the device plus conventional medical management saw a 76.3% reduction in pain over 6 months. In addition, more than 85% of patients were considered responders to treatment -- experiencing 50% or greater reduction in pain.

About 60% of patients in the trial also achieved remission, defined as a pain visual analog scale of less than 3.0 cm for 6 consecutive months, whereas those treated with conventional medical management alone saw no pain relief during this time. Conventional medical management included pharmacotherapies such as first-line agents -- pregabalin (Lyrica), gabapentin (Gralise), or duloxetine (Cymbalta) -- second-line agents (other anticonvulsants like carbamazepine [Tegretol], other serotonin and norepinephrine reuptake inhibitors like venlafaxine [Effexor] or tricyclic antidepressants) -- or other agents like oral opioids or intravenous analgesics.

There were also improvements in dysesthesias, including reductions in numbness, burning, tingling, cold sensations, and sleep disturbances.

The participants will continue to be followed over the next 24 months, the researchers noted.

Nevro stated plans for an immediate commercial launch of the device in the U.S.

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