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.
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 (CMM), to CMM alone in 216 patients across 18 centers in the U.S.
In addition to meeting the primary endpoint, the system proved to deliver statistically significant, clear differences from the best available medical treatments in seven of eight secondary endpoints.
“No conventional, low-frequency SCS treatments have been thoroughly evaluated or demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to offer our innovative treatment option to patients who are unable to find relief with currently available pharmacologic options,” Nevro chairman, CEO & president D. Keith Grossman, Chairman said in the release. “A six-month review cycle by the FDA could position the company to achieve approval and initiate U.S. launch activities to provide HF10 therapy for the treatment of chronic pain in PDN patients during the second half of 2021.”
