FDA Approval for Spinal Cord Stimulation in Diabetic Neuropathy
Nevro Corp. was the first private company to gain FDA approval for spinal cord stimulation specifically for diabetic neuropathy, receiving approval for their 10-kHz high-frequency SCS system (Senza) in 2021. 1, 2
Historical Context of SCS Regulation
The regulatory pathway for spinal cord stimulation devices has evolved significantly over decades:
In 1976, the FDA asserted authority over implantable medical devices, and during the 1980s reviewed neurostimulation devices. 3
The FDA ruled that spinal cord and peripheral nerve stimulation devices could continue to be marketed in the US without formal clinical trials of efficacy based on available publications and expert testimony for general chronic pain indications. 3
However, no company had received specific FDA approval for diabetic neuropathy as an indication until recently. 2
The Breakthrough Approval
Nevro's 10-kHz SCS system received FDA approval based on the SENZA-PDN randomized controlled trial, which enrolled 216 participants with painful diabetic neuropathy refractory to conventional medical management. 4, 5, 1
Key Trial Results Supporting Approval:
76% mean pain relief after 6 months of 10-kHz stimulation compared to conventional medical management alone. 5
Sustained improvements in health-related quality-of-life measures over 12 months, demonstrating durability of effect. 1
No unexpected safety issues in this patient population. 5
Distinction from Traditional SCS
The 10-kHz high-frequency system differs fundamentally from conventional low-frequency SCS:
Traditional low-frequency SCS (LF-SCS) modulates axonal activity in the dorsal column and is paresthesia-dependent (patients feel tingling sensations). 5
10-kHz SCS targets neurons in the superficial dorsal horn and is paresthesia-independent, providing pain relief without causing paresthesias. 5, 6
Current FDA-Approved Pharmacologic Options
For context, the FDA has approved only three medications specifically for painful diabetic neuropathy: duloxetine, pregabalin, and tapentadol extended release. 3, 2 Capsaicin is approved only for foot PDN. 2 The FDA approval of the spinal cord stimulation system represents the first device-based therapy specifically approved for this indication. 2