ReActiv8 (Restorative Neurostimulation)

What is ReActiv8?

ReActiv8, also called restorative neurostimulation™ and multifidus stimulation, is a surgically implanted device that helps manage chronic lower back pain. An electrical impulse activates your muscles to relieve pain.

The device targets your lumbar multifidus muscles. This is a long grouping of muscles located on the lower (lumbar) left and right sides of your spine. These muscles help hold your spine in place and allow you to move. Sometimes, these muscles don’t work as expected. As a result, you may feel pain and discomfort that can take you away from the activities that you once enjoyed.

What does ReActiv8 treat?

A ReActiv8 device may help you manage:

• Degeneration (deconditioning) of the multifidus muscle
• Chronic lower back pain

Your provider may consider this if other types of treatment to manage lower back pain, like medications and physical therapy, aren’t successful.

How does ReActiv8 work?

The neurostimulation device works by activating or turning on your muscle to restore its function. It allows your muscle to build strength so it can function again (reconditioning). This results in pain relief.

Your surgeon will implant the device in your body. You’ll use a remote, similar to the one you use to change the channel on your television, to turn on the device as directed by your healthcare provider. You’ll stimulate your muscles a couple of times each day, usually in timed intervals (for example, 30-minute sessions, twice per day).

How should I prepare for ReActiv8 surgery?

Before surgery, you’ll meet with a healthcare provider to make sure you’re in good health for surgery. They’ll do an exam, learn more about your medical history and run tests. Let your provider know about any medications or supplements you regularly take, as they may adjust those before the procedure.

Your provider will give you instructions specific to your situation, like when to stop eating the night before and when to arrive at the hospital. This is an outpatient procedure. You’ll most likely be able to go home the same day. You should arrange to have someone drive you home and take care of you for at least the first 24 hours after surgery.

What happens during ReActiv8 surgery?

On the day of your surgery, an anesthesiologist will give you general anesthesia. This will put you to sleep so you won’t feel any pain.

Your surgeon will be working near your lumbar spine. This region is designated as “L” for lumbar with a number for each spinal bone or vertebra. Your multifidus muscle is near these bones.

In the operating room, your surgeon will:

1. Make a cut (incision) in your skin at your lower back (above the L4 vertebra)
2. Use an X-ray to guide the lead wire near the L3 vertebra to a nerve called the L2 medial branch
3. Test the lead to make sure it stimulates the muscles correctly
4. Make a second cut in your skin in your butt or lower back
5. Create a pocket to hold the device in your body and insert it
6. Connect the leads to the device
7. Test the device to make sure it works as expected
8. Close the incision sites

What happens after ReActiv8 surgery?

After the procedure, you’ll move to an area of the hospital until your anesthesia wears off. Your care team will monitor you during this time to make sure everything went well.

You’ll be able to go home the same day, but someone will need to drive you.

After the procedure, your surgeon will give you specific instructions to follow. These will include surgical site care, what activities are safe to do and when you can go back to school or work. They’ll also schedule follow-up appointments with you so they can remove stitches, if necessary.

The device won’t be on immediately after surgery. Your provider will give you instructions on how to use the remote and how often you need to turn on the device each day. This usually happens at your first post-op appointment. Let them know if you have any questions about how to use the device or if you notice any new or worsening symptoms during recovery.

What are the benefits of ReActiv8?

The benefits of ReActiv8 may include:

• Lower back pain relief
• Multifidus muscle function improvement
• Ease of movement and spine stability
• Less use of pain relievers

What is the success rate of ReActive8?

One study found that after two years, the ReActiv8 device reduced pain levels from severe to mild levels. In the same study, many people reported that they had better movement control. This device also reduced their need to take as many or any opioids to manage pain.

Your provider will give you the best outlook on what you can expect, as everyone is different, and your case may or may not match statistics.

What are the side effects of ReActiv8 surgery?

All surgical procedures come with possible risks, like surgical site infection, pain and bleeding. The ReActiv8 device has specific side effects that your provider will explain before the procedure. These include:

• Infection
• Device malfunction
• Continued back pain
• Movement of lead wire within your body (lead migration)

These side effects usually require an additional surgery to either remove the device from your body or fix a problem with the device.

What is ReActiv8 surgery recovery time?

It usually takes four to six weeks to recover after ReActiv8 surgery. Your body and situation are unique, so talk to your provider about what you can expect, as this varies slightly for each person.

You’ll likely have some mild pain (known as “pocket pain” where the device sits) and discomfort until your body gets used to the device. This may take up to three months to go away.

How long does a ReActiv8 battery last?

The device implanted within your body has a battery life that should last at least five years with regular use. Often, it lasts longer than this timeframe.

When it’s time to replace the device battery, a surgeon can complete a quick procedure. They’ll open your skin at the previous incision site, replace the battery in the device and then close the incision site. Your surgeon doesn’t need to move the leads or the device from its placement in your body to change the battery.

When should I call my healthcare provider?

Contact your provider if you experience any of the following symptoms after surgery:

• Fever
• Drainage from the incision site
• Swelling that doesn’t improve after several days
• Severe pain or pain that doesn’t improve with medication

What is the difference between ReActiv8 and spinal cord stimulator?

ReActiv8 and spinal cord stimulation are both types of neuromodulation. This is a technique that uses electrical stimulation to affect how your nervous system functions.

Both types of neuromodulation target different areas of your body. ReActiv8 focuses on the multifidus muscle in your lower back to treat lower back pain. You use a remote to tell the device when to send an electrical stimulation to your muscle.

Spinal cord stimulation targets the epidural space, just outside of your spinal canal to treat chronic pain in several areas of your body. It works by disrupting pain signals to your brain. It works on a schedule to continuously deliver pulses of electrical stimulation to your spinal cord to relieve pain.