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In the largest RCT of its kind, Nevro HFXTM demonstrated substantial and durable pain relief, as well as sensory improvement in the majority of patients.1
90% Responder Rate1 (≥50% relief)
80% Average Pain Relief1
65% Experienced Sensory Improvements1
Download: 24-Month PDN RCT Results in Diabetes Research and Clinical Practice
Finally, there’s an FDA-approved nonpharmacological treatment for painful diabetic neuropathy. Patients can try it before they decide, in a one-week temporary trial to evaluate their individual relief.
How it Works
Nevro HFX is a small device placed under the skin that delivers electrical pulses which disrupt pain signals to the brain.
What an endocrinologist has to say about Nevro HFX
Finally, there’s a treatment option for PDN patients refractory to conventional medical management (CMM).
SCS is a well-established approach to managing chronic pain
Nevro HFX uses 10 kHz Therapy to activate inhibitory neurons in the dorsal horn, calming abnormal pain signals to the brain.
Proven to effectively treat chronic pain for over 10 years in 100,000 patients. Now proven safe and effective for patients with diabetes.
At 24 months, the infection rate of just 5.2% (8 of 152 implanted patients) was consistent with reports for other SCS procedures.1
Frequently Asked Questions: Patient Access
- 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
- 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
- A Nevro HFX implanting physician will be able to determine appropriateness of HFX 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
Additional Resources
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