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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

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What an endocrinologist has to say about HFX for PDN

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

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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.

pain-response

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

Download Jama Study
pain-relief

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.

neurologic-response

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