REACTIV8 PATIENT JOURNEY

Questions & Answers for each step of your ReActiv8 Journey

Discovery
Decision
Preparing for Implant
Using The Therapy
Long-Term Expectations

Searching for a CLBP treatment

Identified as a possible candidate

Elected to receive ReActiv8

Post-Implant & Recovery

Living with
ReActiv8

REACTIV8
PATIENT JOURNEY

Questions & Answers for each step of your ReActiv8 Journey

Discovery

Searching for a CLBP treatment

Decision

Identified as a possible candidate

Preparing for Implant

Elected to receive ReActiv8

Using The Therapy

Post-Implant & Recovery

Long-Term Expectations

Living with ReActiv8

Phase 1: Discovery

Initial education on multifidus dysfunction, neuromuscular control, and ReActiv8

1. Pathology

What is mechanical chronic low back pain?
    • Mechanical chronic low back pain results from an injury or stress on the tissues surrounding the spine, including soft tissues, muscles, bones, and joints. Often times, this type of pain is due to impaired muscle control and neural inhibition of the multifidus, which is the largest stabilizing muscle in your back. When this neuromuscular inhibition occurs, there can be lack of spinal support, causing uncontrolled loading and pain. Improving the neuromuscular control of the multifidus muscle can stabilize the spine, thereby increasing function and decreasing pain. ReActiv8 restorative neurostimulation is designed to address the underlying cause of mechanical low back pain by helping patients restore neuromuscular control of the multifidus muscle.
Why is the multifidus muscle important?
    • The multifidus muscle is the key stabilizing muscle in the lower back. Even a single injury to the back can cause impaired muscle control of the multifidus. This lack of muscle control can decrease the spine’s functional stability, leaving the spine susceptible to further injury and overloading. Restoring the neuromuscular control of the multifidus muscle can stabilize the spine, thereby increasing function and decreasing pain.
What is ReActiv8?
    • ReActiv8 is designed to address the underlying cause of mechanical low back pain by helping patients restore neuromuscular control of the multifidus muscle. The device is implanted underneath the skin during a minimally invasive outpatient procedure. A generator is connected to two electrical leads, which are positioned to stimulate the nerves that control your multifidus muscle. The patient controls the twice-daily therapy sessions, which can feel like a deep tissue massage.
How does the therapy work?
    • By stimulating the nerves that activate the multifidus muscle, ReActiv8 overcomes neural inhibition and allows the body to regain control of the multifidus, improving patient function and reducing mechanically based pain.
    • The therapy program ReActiv8 uses is simple: using a remote control, the patient activates a 30-minute therapy session twice a day, which allows the system to contract and relax the multifidus muscle via the stimulation of the medial branch nerve. This presents a comfortable sensation that the patient can perform while resting in bed or on the couch.
    • Once the patient obtains their goals of improved functionality and reduced pain, they can tailor the therapy usage to fit their needs. Some patients still use the therapy twice a day, while others use it as needed. A few even find that they can remove the system in a few years because they no longer require the therapy to keep them functional and pain free.

2. Patient Selection

Am I a candidate for ReActiv8?
    • ReActiv8 is for patients who have mechanical chronic low back pain, but have not found relief through medical management or physical therapy. Candidates should not have had (and are not in need of) spine surgery. Your doctor can help determine if ReActiv8 is right for you.
Does ReActiv8 work for older patients?
    • Yes, ReActiv8 has been shown to provide significant and clinically meaningful benefits in disability, health-related quality of life, and pain in well-selected patients, irrespective of age.
Will this help with my nerve pain?
    • ReActiv8 is for mechanical chronic low back pain and is not indicated for predominantly neuropathic pain such as radiculopathy or complex regional pain syndrome.
Can I get ReActiv8 if I have had back surgery?
    • ReActiv8 is not indicated for patients that have previously had spine surgery in the lumbar region.
What if I also have leg pain?
    • ReActiv8 is best suited for patients whose back pain is worse than their leg pain, assuming their leg pain does not extend below the knee.
Do specialists recommend trying to get in shape first? Or is this for someone who ignored the pain so long it’s just too late?
    • Maintaining a healthy lifestyle is always important, however it is understandable that CLBP may prevent you from doing the amount of activity that you would like. Many patients in the ReActiv8 clinical trials were not able to exercise or successfully do physical therapy due to back pain, but with ReActiv8 therapy, were able to gain function so they could start getting back in shape.
If you stop the pain in the middle of the back shouldn’t that stop the pain from going down your leg?
    • The mechanism that causes radiating leg pain is different from back pain, and ReActiv8 is not indicated to treat the former (leg pain).

3. Insurance FAQs

Is ReActiv8 covered by my insurance? (US)
    • By enrolling in the RSVP program, you are able to increase your access to ReActiv8 through the submission of prior authorization and patient-based appeals facilitated by experts in this area.

Phase 2: Decision

Identified as a possible candidate & making the decision to get ReActiv8

1. Therapy Options

What is the difference between restorative treatments and palliative treatments?
    • Restorative treatments focus on improving function for patients by addressing the underlying cause. Palliative treatments focus on blocking pain through treatments like Spinal Cord Stimulation, oral medication, injections, or burning nerves (RFA, MBB).
What are the key differences between ReActiv8 and Spinal Cord Stimulation (SCS)?

ReActiv8 and SCS are different in almost every way. Most importantly, they each target different CLBP patient populations:

    • ReActiv8 addresses musculoskeletal/mechanical/axial predominantly nociceptive CLBP.
    • SCS addresses predominantly neuropathic CLBP and radiculopathy.

They employ different mechanisms of action:

    • ReActiv8 aims to restore multifidus motor control and functional segmental stability.
    • SCS aims to interfere with the perception of pain with a palliative objective.

They have a completely different delivery schedule:

    • ReActiv8 delivers stimulation to cause repetitive multifidus contractions during two 30-minute sessions daily.
    • SCS typically delivers stimulation 24/7 to cover the pain.
Can SCS devices be used to treat non-surgical CLBP?
    • There is no long-term data to support the use of SCS devices for mechanical CLBP. Physicians should be testing for multifidus dysfunction prior to any interventional therapy. If they test positive for multifidus dysfunction then restorative neurostimulation is the best treatment option. If there is no multifidus dysfunction, then an alternative therapy may make sense.
What about 60-day temporary PNS devices?
    • There is no long-term data to support the use of temporary PNS devices for mechanical CLBP. Physicians should be testing for multifidus dysfunction prior to any interventional therapy. If they test positive for multifidus dysfunction then restorative neurostimulation is the best treatment option. If there is no multifidus dysfunction, then an alternative therapy may make sense.
Is the ReActiv8 system like a TENS (Transcutaneous Electrical Nerve Stimulation) unit?
    • No. The ReActiv8 system is designed to stimulate the nerves that control the muscles that stabilize the lumbar spine. This results in a comfortable therapy that cycles deep muscular contractions, with the goal of restoring your neuromotor control of the lumbar spine. In contrast, TENS units attempt to block painful signals by transmitting electrical signals through your skin. This results in a completely different sensation and does not address the root cause of mechanical back pain.
What is the difference between ReActiv8 and RFA? Can I get ReActiv8 if I’ve had a previous RFA?
    • ReActiv8 is designed to activate your deep stabilizing muscles correctly (physiologically). Radiofrequency ablation (RFA) destroys the nerves that connect the brain to the parts of the spine and deep muscles with the purpose of keeping painful signals from reaching the brain. Unfortunately, this also prevents the brain from communicating to these deep muscles to control spine stability.
How is this different from the other stimulators my doctor has offered me?
    • ReActiv8 is the only neurostimulation therapy that works through a restorative mechanism, retraining your body to function naturally to support your spine. All other stimulators work by attempting to cover up the pain signals.

2. Imaging

What sort of imaging can patients receive with a ReActiv8 system?
    • CT scans, fluoroscopy, ultrasound and X-Ray are all compatible with the ReActiv8 device. Special considerations must be made for MRI scans, however, and patients should review the ReActiv8 manual for more detailed guidance regarding MRIs.
Can I have an MRI (Magnetic Resonance Imaging)?
    • ReActiv8 patients can receive an MRI. The ReActiv8 Implantable Pulse Generator (device) and 45 cm implantable leads (Model 8145) are MR Conditional devices with demonstrated safety in the MR environment only within specified conditions. Refer to the document ReActiv8 System Magnetic Resonance Imaging (MRI) Guidelines for an up-to-date list of approved MR Conditional components, model numbers, and required conditions. Failure to follow these guidelines for MRI scans may result in severe patient injury and/or device malfunction. Consult with your healthcare provider prior to an MR exam and inform MRI site personnel that you have an MR Conditional medical device during MR screening prior to the MR exam. Carry your device identification card with you at all times.
ReActiv8 Pain and Function Improvment

1. Gilligan et al. Five-Year Longitudinal Follow-up of Restorative Neurostimulation Demonstrates Durability of Effectiveness in Patients with Refractory Chronic Low Back Pain associated with Multifidus Muscle Dysfunction. https://doi.org/10.1016/j.neurom.2024.01.006

3. Long-term Clinical Outcomes

What are the outcomes for patient with ReActiv8?
    • Patients experience progressive long-term improvements in pain and function, over time, demonstrating a durable, consistent, and restorative result. This has been demonstrated through multiple clinical studies, with the largest randomized controlled trial demonstrating first of its kind results out to five years.
    • ReActiv8 demonstrated favorable safety profiles compared to other neurostimulators.

Phase 3: Preparing for Implant

Decision to receive ReActiv8 & preparation for procedure

1. Procedure

Will the patient be able to see or feel their implant?
    • While patients will typically be able to feel where the IPG is located with their hands, after 60-90 days, the body will heal around the IPG to the point where it is less perceptible. The patient may be able to see the location of the incisions, but won’t typically be able to see the IPG outline through their skin (when standing naturally) or over clothing. In comparison, neurostimulation systems such as pacemakers are typically much more noticeable due to where they are located.
How does the doctor decide where to place the lead and generator?
    • ReActiv8 and SCS are different in almost every way. Most importantly, they each target different CLBP. While everyone’s body is a little different, the nerve that is stimulated by the ReActiv8 leads is located in the same place in almost everyone. Your doctor will use x-ray images of your spine to obtain the best position of the leads to stimulate the nerve. The IPG (which also contains the battery pack) is generally implanted deep under the skin in the upper part of the buttock, below the belt line and above the seat line, or in the flank between the hips and the ribs, to make it as comfortable as possible. You should discuss the location of the IPG with your doctor before surgery.

Phase 4: Using the Therapy

Post-recovery process & how to use ReActiv8

1. Recovery

After the implant procedure, you will have two incision sites, one central on the back about 1-2 inches in length and another at the location of the battery about 2 inches in length. The incisions will be closed using sutures with either glue, steri-strips, or a plastic incision closing device, then covered with a gauze dressing.

What are my post-op restrictions?
    • Do not submerge in water until you have been cleared to by your doctor. You may shower 48 hours after your procedure, and the dressing should be changed with gauze and tape at that time. If the dressing gets saturated with blood within the first 24 hours, give your physician a call. Some bleeding on the dressing is expected. The dressing may be changed each day as needed after that first dressing change.
    • For activity, we recommend to be out of bed as much as you can without exhausting yourself or worsening your pain.
    • Walking is encouraged. Do not bend or twist to extremes. Do not lift anything heavier than a gallon of milk (about 10 pounds).
    • Talk to your physician about pain control post-surgery. Many patients use Tylenol or NSAIDS along with ice for pain control, but your physician may have a specific plan for you.
    • If using ice, ice for no more than 15 minutes at a time and wait for 15 minutes before reapplying ice to allow the skin to recover so it doesn’t get a freeze burn. DO NOT use heat until follow up.
    • The steri-strips or glue will fall off on its own, so do not take them off yourself. Your doctor will remove anything needed at follow up and inspect the incision for proper healing.
After implant, when can I resume normal activity including exercise/physiotherapy?
    • Limit your activities to low or moderate levels during the first 4-6 weeks after implant. Light impact exercise such as walking or swimming is acceptable. Talk to your physician about what exercise may be right for you.
Can I lift heavy objects?
    • For the first 4-6 weeks, avoid lifting weights heavier than 10 pounds (e.g. a Gallon of milk).
How long until IPG pocket pain is gone?
    • Discuss with your physician ways to mitigate any pocket pain after the implant, as this should not persist for over a couple of weeks. Mild discomfort or awkward awareness of the pocket area typically subsides around 60-90 days.
How long is the recovery process?
    • Your wound will be checked around 10-14 days after surgery, where you will likely get your stitches removed. At this follow-up your system will be activated, and you will be instructed how to use your system and run therapy sessions. It is important to limit strenuous activity in the first 4-6 weeks to allow the system to heal.
Do I need to have someone taking care of me?
    • You will require someone to take you home on the day of your implant, but you should be self-sufficient after the effects of anesthesia wear off.

2. Activation

When does the ReActiv8 Therapy start?
    • The ReActiv8 device will not be turned on until the activation follow-up visit, about 10-14 days after surgery. At that time, the device stimulation will be programmed and individualized to patient therapy needs. The therapy starts with patients performing two, 30-minute sessions each day at convenient times. For most patients, this is typically once in the morning before getting out of bed and once in the evening when going to sleep or watching television.

3. Therapy Usage

How is the device controlled?
    • Using a hand-held remote, the patient controls the twice-daily therapy sessions.
What do the therapy sessions feel like?
    • Most patients say the sessions feel like a pleasant series of deep muscle contractions, like flexing a muscle in an arm or leg, but in the lower back region. The system is programmed to be as comfortable as possible, so that it is easy and even enjoyable to perform the daily therapy sessions.
How long are the therapy sessions? Can I use it for more than twice a day or more than 60 mins per day?
    • The therapy sessions are twice daily for 30 minutes each. The device has a timer on it and does not allow stimulation for more than 60 minutes per day.
Do I have to perform the session on my stomach or side?/Can I do the session on my back?
    • The stomach is the most preferable position because it puts the least amount of pressure on the leads. However, the goal is for you to use the device as much as possible in the first year to achieve the best results. If the back works for you, talk to your Mainstay representative about programming the device in your preferred position to get the most out of your therapy.
Why can’t I do therapy sessions sitting in a chair?
    • It is preferred to perform sessions while laying down to allow your muscles to be fully relaxed. Some recliner chairs or other situations may be acceptable if your muscles can be fully relaxed for the duration of the therapy session.
Why does it feel different when I change my position during a therapy session?
    • Changing position may alter the distance between your leads and the stimulated nerves, causing a slight increase or decrease in stimulation and a different sensation. Talk to your therapy specialist about the best positions to perform your therapy.
What if I miss a therapy session?
    • It is important to perform as many of your prescribed sessions as you can in the first 6-9 months of therapy, however missing a session periodically will not alter your outcomes as long as you are using the majority of your sessions.
Does the lockout start two hours from the start of the last session or two hours from the end of the last session?
    • The lockout period is designed to allow your muscles to rest and prevent overuse of stimulation. The system locks out for 2 hours after the first 30 min session, and for the rest of the day after the second session.
One side seems like it starts before the other, then they feel even - is that normal?
    • Yes, sometimes one side requires more energy output to correctly stimulate the nerve, and it takes longer to comfortably ramp this energy up to the programmed level. This can end up taking longer than the other side and therefore feel different.
When I lay on my side, the side that’s ‘up’ doesn’t feel as strong - should I rotate sides halfway through?
    • Talk to your therapy specialist about the best position for stimulation. Performing sessions on your stomach or your back tend to give more even stimulation, but if you need to do sessions on your side your system can be programmed to give equal stimulation for a constantly used position.
What if I have to use the restroom/answer the door during a session or can’t commit to a 30 minute session?
    • The activator does not have the ability to pause a session. You can stop the session and start a new one at any time. The new session will run for a full 30 min unless you manually stop it.
How do I clean my activator?
    • Soft cloth lightly dampened with warm water.
How long does the ReActiv8 battery last?
    • The ReActiv8 system is tested to have enough battery life to last a minimum of 5 years with continuous use (two 30-minute session per day). However, in practice, ReActiv8 systems have shown to last much longer. If the battery ever does need replacement, a straightforward procedure to switch out the battery can be performed without having to replace the implanted leads.
Do I have to charge the battery?
    • No, the battery is primary cell and does not need to be charged.

Phase 5: Long Term Expectations

Therapy compliance & setting expectations for programmings, follow-ups, and outcomes

1. Expectations & Programmings

How often do I have to come back in for appointments?
    • The ReActiv8 follow-up schedule is tailored to customize the therapy to the patient’s body as it begins to restore control over the supporting muscles of the spine. It is an opportunity to gauge progress and celebrate the journey toward improved functionality and reduced pain. After the activation appointment, further follow-ups at 1, 3, and 6 months (or as needed) will be performed to tune your programming as the patient’s body heals and begins to restore proprioception and spinal stability.

ReActiv8 Follow Up Schedule

2. Outcomes & Results

When will I start seeing results?
    • The majority of patients begin to feel improvement in their ability to function and perform activities with improved confidence between 6 and 16 weeks, but results can take longer than the average range in some patients. Patients report their back pain beginning to decrease shortly after they feel an improvement in function. The data from the clinical trials suggests that improvements seen in function and pain continue to accrue over time and are durable.
    • To maximize the benefit of the therapy, patients are prescribed two therapy sessions a day for the first 12 months or until improvement is made. When significant improvement is made, most patients choose to tailor their therapy to fit their treatment needs and lifestyle.
    • While some patients enjoy their therapy session every day in the long term, most tend to use their system when needed. A few patients have elected to have their system removed after a few years because they felt they had recovered.
    • Physical Therapy prescription may also be encouraged in conjunction with ReActiv8.
Have you seen improvement in the quality of life of patients post-procedure?
    • Quality of life has been measured in multiple studies and shows dramatic improvements out to 5 years.
Are these positive results only seen in controlled clinical studies?
    • No. Patient reported outcomes from various real world studies out to 3 years are consistent with those found in the controlled clinical studies.

3. Future Therapies and Procedures

Do I have it in me forever/can it be removed?
    • The procedure is entirely reversible and the device can be removed by your physician.
    • A small percentage of patients have elected to remove their device due to the resolution of symptoms after a few years of therapy.
Can I have chiropractic manipulation or deep tissue massage with ReActiv8?
    • Ask your physician first. It’s possible that chiropractic manipulation or deep tissue massage could damage your neurostimulator or dislodge the lead, which would cause you to need additional surgery to repair the system. It is generally advised to not attempt anything new/strenuous for the first 3 months as to not influence outcomes from Reactiv8.
If needed, can I have spine surgery at a later date?
    • ReActiv8 always allows for the possibility of any future surgery, as it does not alter the anatomy. However, depending on the surgery you may be required to remove the ReActiv8 device.

4. Expectations and Programming

Can I go through metal detectors or airport security with ReActiv8?
    • Yes, you can walk through metal detectors or screening devices with an implanted neurostimulator. Do not linger inside, and try not to touch the sides of the screening device. Tell the security personnel that you have a “pacemaker for pain” and show your ReActiv8 Patient Identification Card. You may also request a hand search. If the search involves a hand-held security wand, ask them not to hold the wand near your neurostimulator any longer than needed.
Can I use a hot tub with ReActiv8?
    • Yes, assuming that your doctor has cleared your incision as fully healed.
What other devices can I use with ReActiv8?
    • The ReActiv8 system cannot be used with Diathermy. The ReActiv8 system has not been tested with other active devices and you should consult with your physician.
When can I get back to doing sports/lifting weights etc?
    • It is suggested to wait 4-6 weeks before any heavy lifting or strenuous activity to ensure proper healing of your implanted system. Afterwards, refrain from activities that may induce excessive stress on your leads or IPG. For example, jiu jitsu, rowing, etc.
What happens if I get pregnant?
    • The impact of pregnancy on ReActiv8 therapy has not been studied, although there was incidence of this during the ReActiv8-B study. We will turn the device off for the duration of your pregnancy and then we will turn it back on at a later time.
What happens when I travel?
    • It is preferred to take your activator while traveling so you can continue your therapy. However, small interruptions in the therapy will not disrupt the results in the long term. Be aware that the system does not update time zones, so your 2 sessions within a 24- hour period may be shifted. Discuss with a Mainstay representative about how your sessions may be affected.
Can I go scuba diving? How deep can I dive?
    • The device is not designed to go further than 5 meters (16 feet) in depth.
Can I get a massage or chiropractic care with ReActiv8?
    • Yes, but make sure that the practitioner does not manipulate the area where the battery or leads are placed.
Can I get an allergic reaction to ReActiv8?
    • Due to the biocompatible materials used in the construction of ReActiv8, allergic reaction is unlikely. Your physician can assist with allergy testing if needed.
Can I use heavy machinery/welding tools?
    • While the device features protection from electromagnetic interference (EMI), some equipment can produce strong sources of EMI, e.g. transformers, electric welders etc., which may affect the device when in close proximity. Contact your physician if you have any questions.
Can I have phototherapy or infrared light therapy with vibrations?

Safety has not been established specifically with cryotherapy or infrared light therapy with vibration. Generally, these types of therapies are permitted, but note the following:

    • Avoid manipulating or rubbing the implanted components of ReActiv8 through the skin. Manipulation may cause component damage, lead dislodgement, skin erosion, or unwanted stimulation at the implant site.
    • Avoid using these treatments on an unhealed wound.
    • While the device features protection from electromagnetic interference (EMI), some equipment can produce strong sources of EMI, e.g. transformers, electric welders, etc., which may affect the device when in close proximity. Contact your physician if you have any questions.

5. Clinical Studies and Patients Living with ReActiv8

How long has this been on the market for? How many patients have ReActiv8 implanted?
    • Over 1000 patients have been implanted with ReActiv8 across AUS, US, UK, and Germany, including clinical trials and commercially. The development of ReActiv8 started in 2008, with clinical trials beginning in 2014. The long-term outcomes from the clinical trials are nearing the 10-year mark and many patients continue to see significant benefit from the therapy.

To learn more about the clinical studies surrounding the pathology and therapy, visit mainstaymedical.com/clinical.

Can I talk to another ReActiv8 patient?
    • Through the ReActiv8 Patient Ambassador Program, we offer the opportunity for patient-to-patient communications. You can sign up to talk to another patient by clicking here.

 

 

If needed, can I have spine surgery at a later date?
    • ReActiv8 always allows for the possibility of any future surgery, as it does not alter the anatomy. However depending on the surgery you may be required to remove the ReActiv8 device.

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