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Help your patients step into life again

HFX* for PDN is the only spinal cord stimulation system approved by the FDA with a specific indication to treat painful diabetic neuropathy (PDN).

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Introducing HFX for PDN. Finally, a nonpharmacologic approved to treat painful diabetic neuropathy.

85% of patients achieved at least 50% pain relief1

76% average pain relief1

92% of patients were satisfied with their treatment1

What an endocrinologist has to say about HFX for PDN

Finally, there’s a treatment option for PDN patients refractory to conventional medical management.

SCS is a well-established approach to managing chronic pain

The HFX Solution uses 10 kHz Therapy to activate inhibitory neurons in the dorsal horn, calming abnormal pain signals to the brain.


85% of patients receiving 10kHz Therapy achieved more than 50% pain relief vs CMM1

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Patients receiving 10kHz Therapy experienced 76% average pain relief vs CMM1

Compared to conventional medical management alone, the HFX Solution is proven to significantly reduce pain from diabetic neuropathy using 10 kHz Therapy.


Additional RCT observations include neurological response1

Reduced numbness, burning, tingling, and cold sensation for patients receiving 10 kHz Therapy.

Proven safe and effective for patients with diabetes1

At 6 months, 3 of 90 patients receiving 10 kHz therapy (3.3%) experienced infections.

Frequently asked questions about patient access

Is SCS covered under Medicare?

  • SCS is covered under the Medicare Part B benefit
  • Spinal cord stimulation is broadly covered by a National Coverage Decision for “chronic tractable pain of the trunk and limbs” with more specific local coverage determinations for some Medicare Administrative Contractors (MACs)
  • SCS trial and implant procedures do not require prior authorization except when done in the Hospital Outpatient setting
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How is SCS covered under a commercial health plan?

  • SCS is covered under the medical benefit of the health plan
  • Spinal cord stimulation is broadly covered by all major commercial health plans with specific coverage language and indications varying by plan type
  • Prior authorization of the SCS trial and implant procedure is typically required for all commercial health plans
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How is individual patient coverage determined?

  • An HFX implanting physician will be able to determine appropriateness of the HFX Solution for their PDN patients
  • Due to medical necessity requirements, a detailed clinical history of tried and failed conservative therapies will be needed to facilitate access during the prior authorization process
  • Individual out of pocket amounts will be determined during benefit investigations and will be based upon individual plan details, deductible limits, and out of pocket maximum amounts
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Request a representative

Learn more about HFX for PDN by speaking with one of our representatives

Send an email