In July 2021, the U.S. FDA granted a specific indication for Nevro’s 10 kHz therapy to treat PDN, following strong randomized-trial results.
What Is HFX 10 kHz Therapy?
Spinal cord stimulation uses a small implanted pulse generator and thin leads placed near the spinal cord to deliver gentle electrical pulses that modulate pain signaling. HFX delivers high-frequency (10 kHz) stimulation that does not create tingling (no paresthesia), which helps many people wear it all day without noticing the stimulation.
Why 10 kHz for PDN?
PDN pain can persist even with excellent diabetes care and guideline-based medications. In the landmark SENZA-PDN randomized clinical trial, adding 10 kHz SCS to conventional medical management provided large, durable pain reductions and meaningful functional gains compared with medications alone.
- Durable pain relief: At 24 months, average pain reduction was about 80%, and approximately 90% of patients achieved at least 50% pain relief.
- Neuropathic symptom improvement: Clinically meaningful gains on validated neuropathic pain measures.
- Sensory and functional improvements: Many patients demonstrated improved foot sensation and better sleep and activity levels.
Independent publications and real-world analyses report similar outcomes, including better quality of life and sleep and high patient satisfaction.
How It May Help Restore Function
When pain eases and sensation improves, people often regain confidence in their feet. That can translate into:
- Better balance and stability during walking
- More total daily steps and participation in activities
- Improved sleep quality, which supports healing and energy
- Greater independence in daily tasks and self-care
Notably, the SENZA-PDN program documented not just pain relief but investigator-assessed improvements in sensory testing for a majority of patients—an encouraging signal that goes beyond masking pain.
Who May Be a Candidate?
- Painful diabetic neuropathy for 12 months or longer
- Inadequate relief or side effects on standard medications
- Reasonable glycemic control and medical optimization
- No active infection or unhealed foot ulcers
- Realistic goals (less pain, better function, improved sleep)
Your pain specialist will also review your imaging, medication history, and any anesthesia or bleeding-risk concerns.
What the Process Looks Like
- Evaluation & goal-setting: Confirm diagnosis, review prior treatments, and align on measurable goals (e.g., reduce pain to ≤3/10, walk 30 minutes most days, sleep through the night).
- Trial (temporary leads): A short outpatient procedure places thin leads through the skin and connects them to an external battery for about 5–7 days. You live your normal routine while tracking pain, sleep, and function.
- Decision: If you achieve meaningful improvement (commonly ≥50% pain relief and better function), you may opt to proceed.
- Implant: A small pulse generator is placed under the skin and connected to the leads. Most people resume light activity within days per clinician guidance.
- Personalization & follow-up: Your care team fine-tunes programs wirelessly over time. Many patients report steady gains in the first weeks to months.
Safety and Side Effects
All procedures carry risk. Potential issues include lead migration, infection, discomfort at the implant site, or need for reprogramming. In published SENZA-PDN studies and follow-ups, most adverse events were manageable, and long-term benefit was common. Your physician will review risks in the context of your health profile.
How Does HFX Compare with Conventional SCS?
Traditional lower-frequency SCS often produces tingling sensations and has mixed evidence in PDN. HFX 10 kHz is paresthesia-free and uniquely carries an FDA indication for PDN based on randomized-trial evidence. It isn’t the right choice for everyone, but it’s an important option to consider if medications fall short.
Insurance Coverage
Following FDA clearance and growing clinical evidence, payer coverage for 10 kHz therapy in PDN has expanded. Coverage varies by plan; our team can help with verification and any preauthorization steps.
Smart Questions to Ask Your Clinician
- Am I a good candidate for HFX 10 kHz therapy given my diabetes history?
- What goals should I track during a trial?
- How will this therapy interact with my other conditions or devices?
- What does long-term follow-up and battery replacement look like?
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