Nevro HFX™ Spinal Cord Stimulation
Spinal cord stimulation for chronic back, leg, and diabetic nerve pain, with relief that doesn't depend on tingling
How HFX works
Chronic nerve pain happens when damaged nerves send too many pain signals to the brain. Spinal cord stimulation quiets those signals at the source, using gentle electrical pulses delivered to the spinal cord.
HFX is a small implant, about the size of a pacemaker, that provides relief day and night. It pairs with a smartphone app you use to track your relief and adjust your therapy.
Before committing to an implant, you try HFX for approximately 7 days to see how well it works for you.
What makes HFX different
Relief without tingling
Traditional stimulators cover pain with a tingling sensation called paresthesia, which some people find uncomfortable. HFX's 10 kHz therapy can relieve pain without it.
High and low frequency in one device
HFX can deliver both high-frequency and traditional low-frequency stimulation, giving your physician more options to find and keep your best relief.
An app that learns from you
You complete short check-ins on your pain, activity, sleep, and medication use. HFX uses your answers to recommend program changes†, and you decide whether to make them.
Approved for more types of pain
Along with back and leg pain, HFX is FDA-approved for painful diabetic neuropathy and for back pain in people who haven't had back surgery and aren't candidates for it.
In a large randomized study comparing HFX's 10 kHz therapy with traditional spinal cord stimulation, after 2 years 77% of patients with back pain and 73% with leg pain had at least half their pain relieved with HFX, compared with 49% using a traditional stimulator.1
Individual results vary.
See how HFX relieves chronic pain
Your path to relief
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Consultation
Meet with one of our physicians to review your pain, its location and history, and the treatments you've tried, and decide whether HFX may be right for you.
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Trial
Try HFX for approximately 7 days with a temporary external device. The trial procedure is similar to an epidural injection, needs no incisions, and you go home the same day. If you get at least 50% relief, you can move forward with the implant.
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Implant
HFX is placed in an outpatient procedure through two small incisions, with anesthesia or sedation for comfort. The device sits under the skin in your lower back or buttock. Recovery typically takes 4 to 8 weeks.
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Fine-tuning
About a week after your implant, your device is turned on and programmed. You'll work with your care team and a dedicated HFX Coach to find the settings that give you the most relief.
Is HFX right for you?
HFX may be an option if:
- You have nerve-related chronic pain that has lasted more than six months
- Your pain is in your back, trunk, legs, or arms
- You haven't found relief with other treatments
- You've had back surgery and still have pain, aren't a candidate for back surgery, or have painful diabetic neuropathy in your feet or legs
Our physicians will review your symptoms, exam, and imaging to determine whether spinal cord stimulation is a good fit for you.
Important safety information
Patient experiences with the HFX iQ™ or Senza Omnia™ spinal cord stimulation (SCS) system vary by individual, including the amount of pain relief. The occurrence of adverse effects associated with SCS implant surgery or use also varies by patient.
Indications for Use: The HFX iQ, Senza Omnia, and HFX Trial spinal cord stimulation systems aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. These systems when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy and the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).
Contraindications: These include patients who are poor SCS surgical candidates, are unable to operate the SCS system and fail to receive effective pain relief during trial stimulation.
Warnings: Safety and effectiveness has not been established for pediatric use or in pregnancy. Interference with other implanted stimulators, such as cardiac pacemakers and defibrillators which have sensing features and may result in sensing problems or inappropriate responses. Sources of electromagnetic interference (theft detectors, security screening devices, power lines, RF equipment, mobile phones, radio systems, electrostatic discharge etc.) may interact with the system, resulting in unexpected changes in stimulation, serious patient injury and system damage. Energy from diathermy can be transferred through the implanted system and can cause tissue damage, resulting in severe injury or death. Senza implantable stimulators are MR conditional and scanning under different conditions may result in severe patient injury or device malfunction. Use of certain medical devices or procedures (electrocautery, radiation therapy, ultrasonic scanning) may result in device damage. Induced electrical currents from radiofrequency (RF) or microwave ablation may cause heating, resulting in tissue damage.
Precautions: Avoid activities that put stress on the implanted spinal cord stimulation system components. Safety has not been established for Transcranial Magnetic Stimulation (TMS) or Electroconvulsive Therapy (ECT) in patients who have an implanted SCS system. Patients experiencing persistent discomfort or excessive redness around the wound areas may need to be checked for infection by their physician.
Adverse Events: May include hematoma, epidural hemorrhage, paralysis, pain at implant site, infection and other surgical risks. Device related adverse events may include loss of pain relief or paresthesia, undesirable change in stimulation (uncomfortable, jolting or shocking sensation), tissue reaction or allergy to implanted materials.
Refer to www.nevro.com/manuals for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events.
†HFX AdaptivAI™ customized programs are pre-defined parameters programmed by the physician.
1Kapural L, et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery. 2016;79(5):667–677.
HFX, HFX iQ, HFX AdaptivAI, HFX Coach, Senza Omnia, Nevro, and the Nevro logo are trademarks or registered trademarks of Nevro Corp. Images and video courtesy of Nevro Corp.