Nevro: Using neurostim to treat painful diabetic neuropathy
Nevro recently touted the results of a trial of its Senza system for treating painful diabetic neuropathy (PDN).
Redwood City, Calif.-based Nevro, which published the results of the SENZA-PDN trial in JAMA Neurology, said in a news release that, if approved, the Senza spinal cord stimulation (SCS) system would be the first FDA-approved SCS system with a specific on-label indication for treating PDN. Senza is already approved for chronic pain from other sources.
The randomized SENZA-PDN trial met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said. The trial compared Senza, plus conventional medical management, to medical management alone in 216 patients across 18 centers in the U.S.
The system and its high-frequency therapy could address the many diabetic neuropathy patients who cannot find relief with medication, Nevro CEO D. Keith Grossman said when the company applied for FDA approval in November. Assuming a six-month review cycle and FDA approval, Senza could launch in the second half of 2021, the company said.