Important safety information
100,000 people treated
Proven safe and effective
Who is a candidate for HFX?
Only an HFX-trained doctor can evaluate your condition to determine if HFX is right for you.
You could be a candidate for HFX if:
- You’re experiencing nerve-related chronic pain (pain lasting over 6 months)
- Your pain is in your back, trunk, legs, and/or arms
- Your pain is difficult to treat, and you haven’t found relief with other pain management treatment options
And/or you have one of the following conditions:
- You’ve had back surgery and are still experiencing pain (failed back surgery syndrome)
- You aren’t a candidate for back surgery (non-surgical refractory back pain)
- You have painful diabetic neuropathy in your feet or legs
Who isn’t a candidate for HFX?
HFX isn’t for everyone. HFX may not be appropriate for you if:
- You didn’t experience effective pain relief during your trial
- You have pre-existing medical conditions that may not make you a good candidate for the procedure
- You can’t operate the device
Important safety, side effects, and risks information
The safety of HFX has been thoroughly studied and proven. HFX has a similar safety profile, including side effects and risks, to other spinal cord stimulation devices that have been available for many decades and HFX is proven to be as safe as all other traditional spinal cord stimulation systems.
Some people may be at a higher risk for surgical complications, including people with diabetes. Please discuss the risks with your HFX-trained doctor so you both can understand all the risks involved.
It’s important to note not all people respond to spinal cord stimulation in the same way, and results may vary.
You will try HFX first in a 1-week trial to see if it’s right for you.
During your HFX trial, the area is numbed, and a thin, flexible wire (called a lead) is typically placed through a
small needle into your epidural space next to your spinal column. This procedure is very similar to an epidural
injection and doesn’t require any incisions.
The procedure takes about an hour, and you’ll go home the same day. You will need to bring someone with you to drive you home.
Uncommon risks that can happen from this procedure include bleeding, infection, pain at the procedure site,
headache from a cerebrospinal fluid leak, and in very rare cases, the possibility of neurological damage.
For a successful trial, the most important thing is to keep the site clean and dry and not do any activities that
will move your leads.
During the implant procedure, a lead is placed again. It’s possible your surgeon may recommend an alternative approach using a flat “paddle” lead directly into the epidural space with similar risks.
If you and your doctor decide HFX is right for you, you will then discuss what the implant procedure involves.
During a minimally invasive procedure, your surgeon will place the device, similar in size to a pacemaker, under your skin. HFX is placed in your lower back or buttocks area; you and your doctor will decide which location will be most comfortable for you.
The implant procedure typically takes up to two hours and is performed with anesthesia or sedation to make it as comfortable as possible. You’ll typically go home the same day and you will need to bring someone with you to drive you home.
Like other minor surgical procedures, complications can include anesthetic risks, infection, poor wound healing, and pain at the procedure site.
These types of events are generally expected with any kind of procedure, and almost all of them are resolved on their own or with medication within a few weeks or months.
Most complications are mild or temporary but in extremely rare cases can cause serious injury or death.
Always talk to your doctor if you have any questions or concerns during your recovery.
It’s possible you may experience complications after the device is implanted, which can include loss of
pain relief, lead migration, allergy, and pain or uncomfortable stimulation from lead migration.
These complications can be resolved by reprogramming the device, medical treatment, corrective surgery, or
removing the device.
The recovery period is about 4-8 weeks. During this time, you should engage only in light activity while you
recover and avoid lifting items that weigh more than 5 pounds, twisting, bending, climbing, stretching and any
movement that involves reaching over your head.
With your doctor’s approval, generally, after your recovery period you can do things like swim, travel, and return to the activities you love.
Low frequency safety information
If your device is programmed to low frequency (1,200 Hz or less), there are some extra precautions you need to take.
When using a low frequency program, you’ll typically feel a mild paresthesia (a sensation commonly felt as tingling, buzzing, or numbness) to help mask your pain.
If you change your posture or move abruptly, this could cause a decrease, or uncomfortable/painful increase, in the tingling sensation felt. To prevent this, you can easily turn the stimulation down or off before changing your posture. If you do feel uncomfortable or painful sensations at any time, you can stop this feeling by turning off stimulation immediately.
Due to the uncomfortable or painful sensation that can occur with low-frequency stimulation, don’t operate any automobile, other motorized vehicles, or dangerous equipment while running low-frequency stimulation. This sensation can cause sudden changes which could distract you from attentively operating the vehicle or equipment.
HFX is the only device that offers paresthesia-free (no tingling) programs, letting you just feel pain relief.
HFX and MRI compatibility
- HFX is generally safe for an MRI scan; however, different models of the device, including lead types, result in different approved MRI scanning conditions.
- People who need MRI scans as part of their healthcare should talk about HFX with their doctor.
- When you need an MRI, we have a dedicated team who will help you find a center that is compatible with spinal cord stimulators, help gather the information you need, and verify your compatibility.
FOLLOW INSTRUCTIONS FOR USE AT ALL TIMES
Please see the Patient Manual for additional safety information and detailed MRI information at www.nevro.com/manuals.