The St. Jude Medical™ Invisible Trial System for spinal cord simulation (SCS) is an easy way to try out SCS with your doctor’s supervision. Our discreet, temporary system uses a small external generator that easily hides under your clothing. You can even adjust your therapy wirelessly using a familiar Apple† iPod Touch† controller. The trial device doesn’t need to be implanted and can be easily removed, so it’s a great way to try out the treatment before you decide to have an implant.
A SIMPLE 3-PART SYSTEM
Our invisible trial system includes just three parts: an external pulse generator (EPG), thin insulated wires called leads and a digital patient controller
EPG: A compact device that sends small electric pulses to the leads
Leads: Thin wires that deliver the EPG’s stimulating electrical pulses to nerves along the spinal cord.
Patient Controller: A handheld device that lets you adjust your therapy wirelessly. The St. Jude Medical™ Invisible Trial System for SCS uses an Apple† iPod Touch† mobile digital device.
HOW IT WORKS
With our temporary neurostimulator, you and your doctor can see if neurostimulation helps control your chronic pain before you get a permanent implant. The system works just like an implantable system, but can be removed
TRYING OUT SCS WITH OUR INVISIBLE TRIAL SYSTEM
See how our invisible trial system uses an external pulse generator (EPG) and familiar wireless technology to provide a simple, discreet way to try spinal cord stimulation (SCS) therapy.
ABOUT BURSTDR™ STIMULATION
What’s more, the St. Jude Medical™ with the St. Jude Medical™ Invisible Trial System for SCS, you can try both the revolutionary BurstDR™ stimulation as well as traditional tonic stimulation.
BurstDR™ stimulation is a unique low-energy neurostimulation therapy that changes the way pain signals travel to your brain. It actually changes the way you perceive pain, providing potential relief from physical pain as well as the physical and emotional challenges that come with it.1
SEE HOW BURSTDR™ WORKS
See how BurstDR™ may help people with chronic leg and/or back pain find relief.
If you’ve tried traditional neurostimulation in the past and it didn’t work for you, or if you experienced side effects you couldn’t tolerate, Abbott’s proprietary BurstDR™ stimulation has been clinically proven to:
- Provide better pain relief than traditional neurostimulation therapy1
- Reduce or eliminate the tingling sensation felt with traditional neurostimulation1
- Make it easier to perform everyday activities*1
- May provide extended relief with a low-energy, low-maintenance device2,3
While neurostimulation helps most patients experience at least some reduction in pain, not everyone responds in the same way. The amount of pain relief varies with each individual. Complications related to placement and/or use of the device may occur, including infection, swelling, bruising and possibly the loss of strength or use in an affected limb or muscle group (i.e., paralysis). Be sure to talk to your doctor about the risks associated with the placement of a neurostimulation system.
WHAT’S THE DIFFERENCE BETWEEN TRADITIONAL NEUROSTIMULATION AND BURSTDR™ STIMULATION?
When you feel pain, it is because your nerves are sending pain signals to your brain. Traditional neurostimulation uses a small device to interrupt pain signals before they reach your brain. It replaces pain with a different feeling, which some people describe as a tingling or massaging sensation. BurstDR™ is Abbott’s proprietary form of neurostimulation.
Similarly, BurstDR™ stimulation works to reduce pain by altering the pain signals as they travel to the brain. However, BurstDR™ stimulation was designed to manage chronic pain more naturally by mimicking some of the natural patterns in your brain. 3 Most patients do not feel any sensation with BurstDR stimulation.1 Depending on what your doctor thinks is best for you, you can receive either kind of therapy with the Proclaim™ Elite Recharge-Free SCS System.
HOW LONG WILL THE TRIAL LAST?
Typically, a trial lasts five to ten days. Your doctor can tell you more about the length of your trial.
WILL I HAVE TO STOP TAKING MY MEDICATION DURING THE EVALUATION?
While many doctors allow their patients to take medications during the evaluation, every doctor has a different approach. Ask your doctor about taking medication during your evaluation.
DOES THE TRIAL SYSTEM PROCEDURE HURT?
Most people receive medication to help with any discomfort and anxiety they may feel as the leads are inserted. However, you may still feel sore at the insertion site afterward.
IS THE TEMPORARY SYSTEM REMOVABLE?
Yes. One of the benefits of the temporary evaluation is that it is designed to be removable. It is frequently performed in a doctor’s office or day surgery center.
WHAT CAN I DO DURING THE TEMPORARY EVALUATION? WILL I BE ABLE TO WORK?
The purpose of the evaluation is to determine your response to neurostimulation and to find out if it helps you manage your chronic pain throughout the day. You may be encouraged to try light activities, such as walking, to see if neurostimulation relieves your pain during those activities. Your doctor may advise you to avoid physically challenging activities. If your job is very physical, you may or may not be able to return to work. Your doctor will determine what is best for you.
WILL MY INSURANCE COVER THIS?
The evaluation procedure and implanted system are typically covered by most major insurance plans, Medicare and workers’ compensation programs. You will need to work with your doctor’s office and insurance company to determine your coverage.
WHAT ARE THE RISKS?
Talk to your doctor about complications related to the implant procedure and/or device, which include:
- Undesirable changes in stimulation
- The loss of strength or use in an affected limb or muscle group (e.g., paralysis)
See more risks.
See answers to more frequently asked questions about neurostimulation.
While neurostimulation helps most patients experience at least some reduction in pain, not everyone responds in the same way. The amount of pain relief varies with each individual. Complications related to placement and/or use of the device may occur. Be sure to talk to your doctor about the risks associated with the placement of a neurostimulation system.
Brief Summary : Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications for Use: Spinal cord stimulation as an 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 and intractable low back and leg pain.
Contraindications: Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
Warnings/Precautions: Diathermy therapy, implanted cardiac systems, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted.
Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Clinicians manual must be reviewed for detailed disclosure.
To review the full Impotant Safety Information (ISI), please click HERE
†Apple and iPod Touch are trademarks of Apple, Inc.
*Based on PGIC scores of moderately better improvement or higher.
1. Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018;21(1):56-66.
2. Deer, T. (2019). Efficacy of Burst Spinal Cord Stimulation Microdosing in a De-Novo Patient: Preliminary Analysis. Presented at NANS 2019.
3. Byrne, J.H. Analysis of synaptic depression contributing to habituation of gill-withdrawal reflex in Aplysia californica. Journal of Neurophysiology. 1982;48(2),431-438.
IMPORTANT SAFETY INFORMATION
SPINAL CORD STIMULATION
PRESCRIPTION AND SAFETY INFORMATION
Read this section to gather important prescription and safety information.
This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.
INDICATIONS FOR USE
This neurostimulation system is indicated as an 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 and intractable low back and leg pain.
This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
MRI SAFETY INFORMATION
Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician’s manual for neurostimulation systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.
The following warnings apply to this neurostimulation system.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.
During implant procedures, if electrosurgery devices must be used, take the following actions:
- Use bipolar electrosurgery only.
- Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.
- Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.
- Set the electrosurgery device to the lowest possible energy setting.
- Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.
Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.
The following precautions apply to this neurostimulation system.
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.
Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)
Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.
Sterilization and Storage
Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.
Handling and Implementation
Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.
System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.
Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
- Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
- Stimulation in unwanted places (such as radicular stimulation of the chest wall)
- Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
- Persistent pain at the IPG site
- Seroma (mass or swelling) at the IPG site
- Allergic or rejection response to implant materials
- Implant migration or skin erosion around the implant
- Battery failure