The Proclaim™ Elite Recharge-Free SCS System delivers revolutionary BurstDR™ stimulation to help you find the relief you need to take control of your life again. Along with advanced chronic pain relief, the patient-friendly design helps you focus on the things you care about — not your pain or managing it.
FAMILIAR TECHNOLOGY THAT FITS INTO EVERYDAY LIFE
The Proclaim™ Elite Recharge-Free SCS System is controlled through Apple‡ mobile digital devices and Bluetooth® wireless technology, so it fits seamlessly with the technology you use every day.
Future Ready: The system is upgradeable, so you won’t need additional surgery to benefit from our next advancement in chronic pain therapy. When new therapies are approved and available, they can be delivered to your implantable pulse generator (IPG) via software updates.
MR Conditional: Our newest neurostimulation systems allow scanning with a wide variety of medical imaging techniques, including magnetic resonance imaging scans (MRIs).** Learn more about MR conditional devices.
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 discuss the risks and benefits of neurostimulation with your doctor.
The Proclaim™ Elite SCS system delivers two types of spinal cord stimulation therapy: the revolutionary BurstDR™ stimulation, as well traditional tonic stimulation. The system includes a small device called an implantable pulse generator (IPG) that’s implanted in the body along with thin, insulated wires called leads. When your system is turned on, the generator sends mild electrical pulses through the leads to nerves along your spinal cord to reduce the level of pain you feel.
SEE HOW BURSTDR™ WORKS
See how BurstDR™ stimulation may help people with chronic leg, and/or back pain find relief – and why many say they prefer BurstDR™ stimulation.2
ABOUT BURSTDR™ STIMULATION
BurstDR™ stimulation is a unique kind of neurostimulation that changes the way pain signals travel to your brain. It actually changes the way you perceive those signals, providing potential relief from the physical pain as well as the physical and emotional challenges that come with it.1
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 to1:
· Provide better pain relief than traditional neurostimulation therapy
· Reduce or eliminate the tingling sensation felt with traditional neurostimulation
· Make it easier to perform everyday activities‡
TRY IT OUT BEFORE YOU DECIDE
One of the advantages of a neurostimulator is that you can try the therapy using a temporary system before committing to an implanted system. Learn more about trying a system.
WHAT’S THE DIFFERENCE BETWEEN TRADITIONAL NEUROSTIMULATION AND BURSTDR™ STIMULATION?
When you feel chronic 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 unique, proprietary form of neurostimulation.
Similar to tonic, BurstDR™ stimulation works to reduce chronic 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.
CAN I GET MAGNETIC RESONANCE IMAGING (MRI) SCANS WITH THIS DEVICE?
You may or may not be able to get a full-body scan with the Proclaim™ Elite Recharge-Free SCS System. Ask your doctor if you may be eligible for what’s called an MR Conditional scan within approved parameters.4,5
Learn more about MRI scans and electromagnetic interference (EMI).
IS IT SAFE TO PASS THROUGH METAL DETECTORS?
Some metal detectors and anti-theft devices may affect your stimulation therapy. Before you go through these kinds of devices, show your device ID card to security personnel and ask how best to proceed.
If you have to go through a metal detector or anti-theft device, turn off your neurostimulator and proceed carefully, moving quickly through the device. Once passing through the detector or device, be sure to check the status of your IPG.
Learn more about MRI scans and electromagnetic interference (EMI).
CAN THE PROCLAIM™ ELITE RECHARGE-FREE SCS SYSTEM HELP ME WTH PAIN IN MULTIPLE AREAS?
Your doctor may place more than one lead (thin wires that deliver electrical pulses) in areas along your spine that match areas where you may feel pain. Talking to your doctor about the specific areas where you feel pain can help identify potentially appropriate placement for the leads.
WILL THE PROCLAIM™ ELITE RECHARGE-FREE SCS SYSTEM HELP ME CUT BACK ON PAIN MEDICATIONS?
Every person responds differently to neurostimulation. Many people with SCS find they don’t need to take as many pain medications.
HOW LONG WILL THE PROCAIM™ ELITE RECHARGE-FREE SCS SYSTEM LAST?
This system contains a battery that does not need to be recharged. How long a recharge-free system lasts depends on its settings and how often it is used. The benefit of a recharge-free system is that it requires little effort to maintain. Learn more about the system’s battery and getting a replacement system.
WILL THE IMPLANTED DEVICE BE VISIBLE?
It depends on the size and shape of your body and where the device is implanted. For many people, it is not visible. However, some people can see the outline of the device and feel it just beneath their skin.
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.
Find answers to more frequently asked questions.
While neurostimulation helps most patients experience at least some reduction in chronic 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 is a trademark of Apple, Inc. Bluetooth and the Bluetooth logo are registered trademoarks of Bluetooth SIG, Inc.
*Based on 12-month data studied by Deer.1
**Within approved parameters.
†Based on PGIC scores of moderately better improvement or higher.
1. Deer T., Slavin K.V., Amirdelfan K., North R.B., Burton A.W., Yearwood T.L., Tavel E., Staats P., Falowski S., Pope J., Justiz R., Fabi A.Y., Taghva A., Paicius R., Houden T., Wilson D. 2017. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation 2017; E-pub ahead of print. DOI:10.1111/ner.12698
2. Deer, T., Slavin, K., North, R., Staats, P.,Burton, A., Davis, K., and Hutson, C. (2017). Randomized, Controlled Trial Assessing Burst Stimulation for Chronic Pain: Two-year Outcomes from the SUNBURST Study. Presented at the 2018 North American Neuromodulation Society Annual Meeting. Las Vegas, NV.
3. De Ridder, D., Vanneste, S., Plazier, M., & Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude Medical’s Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices, 12(2), 143–150.
4. St. Jude Medical (2016). St. Jude Medical™ Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX.
5. St. Jude Medical (2017). St. Jude Medical™ MRI Procedure Information Clinician’s Manual. Plano, TX.
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