NEUROMODULATION
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BE BOLD.
EMPOWER YOUR PATIENTS TO LIVE XR.

Give your patients superior* pain relief with the Proclaim™ XR SCS system; a battery that lasts up to 10 years at low-dose settings** without the hassles of recharging.

SUPERIOR* PAIN RELIEF WITH A BATTERY THAT LASTS UP TO 10 YEARS AT LOW-DOSE SETTINGS**  

 

LOWER THE DOSE, RAISE YOUR EXPECTATIONS

The Proclaim™ XR Recharge-Free SCS system allows patients to attain relief from chronic intractable pain of the trunk and limbs.26

By delivering low doses of stimulation, the system's battery can last up to 10 years** without the burden of recharging.

BE CONFIDENT IN THE THERAPUTIC WINDOW

Dosing simulation can maintain theraputic effect while lowering risk of overstimulation.19

THE PROCLAIM™ XR SCS SYSTEM BACKED BY THE BOLD GUARANTEE

Chronic Pain Exercise icon
  • Up to 10-year battery life at low-dose settings**
  • Freedom from the hassles of recharging 
  • Superior* BurstDR™ stimulation therapy1
  • Familiar Apple‡ devices
  • Upgradeable platform
  • Full-body MR conditional labeling***
  • Backed by an industry-leading 5-year battery-life warrranty

A PROPRIETARY WAVEFORM THAT IS UNIQUELY DOSABLE

BurstDR™ stimulation is a unique and proprietary waveform that mimics natural firing patterns in the brain.3 A non-linear charge accumulation phase creates a powerful signal that modulates both the medial and lateral pathways in the brain. This unique mechanism of action gives patients relief from both physical pain and the emotional suffering associated with the pain.1 Additionally, there is an observed carry-over effect20 meaning the therapy is effective even after stimulation is turned off.19

 

Lat and Med Burst  pathways

 

UNIQUE CHARACTERISTICS OF BURSTDR™ STIMULATION

Waveform graphic

BURSTDR™ STIMULATION DELIVERS CONSISTENT, POSITIVE RESULTS1-2,5-19,21,23-25

BurstDR stimulation has not only proven to have superiority over tonic stimulation in a large, randomized, controlled trial,1 but it has also shown consistent and replicable results across diverse clinical settings around the world for over a decade.1-2,5-19,21,23-25

In 970 patients, over 10 years, and 3 continents, BurstDR™ stimulation has been proven to provide consistent, repeatable, and superior* relief from pain and suffering.1-2,5-19,21,23-25

VNS slash NRS score chart

Weighted average = an average that normalizes for study size. Based on the collection of final VAS/NRS scores from publications using BurstDR™ stimulation. Not all real world data came from randomized controlled multicenter clinical studies.

PATIENTS PREFER THE RELIEF AND CONTROL OF BURSTDR™ STIMULATION1,2,5,6,8,11,13,14

Patient preference for BurstDR™ stimulation is clear – and supported by a growing body of clinical evidence from around the world. Replicable clinical experience indicates that 8 out of 10 patients prefer BurstDR™ stimulation for their chronic pain.2

8 out of 10 image

Based on weighted average from studies with preference data

BURSTDR™ STIMULATION IS UNIQUELY DOSABLE19

BurstDR™ stimulation’s unique and proprietary waveform characteristics have an observed carry-over effect,20  allowing it to be dosed without sacrificing efficacy.19

The BOLD study evaluated the therapeutic efficacy of different BurstDR stimulation dosing programs in patients with chronic intractable pain. Dosed BurstDR stimulation delivered statistically significant reductions in pain, and led to improved quality of life.19

BOLD pie chart image
Reorder Number Weight (g) Battery

3660

48.9

5.3 Ah

3662

58.3

7.5 Ah

QUESTIONS ABOUT REIMBURSEMENT?

We’ve got the answers you’re looking for.

 

BurstDR™ neurostimulation, exclusively from Abbott, is also referred to as Burst stimulation in clinical literature.

The BoldXR™ dosing protocol is only a guide and each patient should be programmed as needed to ensure the best outcome. It should not replace the IFU or recommendations and advisement of the treating health care practitioner.

*Superiority when compared to traditional tonic SCS in SUNBURST.
**Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. NOTE: In neurostimulation therapy, ‘dose’ refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information. Hassle-free means recharge-free.
***Refer to the Instructions for Use for full details on the Proclaim™ XR IPG MR Conditional scan parameters.
†Pain and suffering as measured by VAS
‡Apple is a trademark of Apple, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc.

References

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. 2017;20(6):543-552.
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. Van Havenbergh, T., Vancamp, T., Van Looy, P., Vanneste, S., & De Ridder, D. (2014.) Spinal cord stimulation for the treatment of chronic back pain patients: 500-hz vs. 1000-hz burst stimulation. Neuromodulation, 18(1), 9-12.
5. Schu, S., Slotty, P.J., Bara, G., von Knop, M., Edgar, D., & Vesper, J. (2014). A prospective, randomized, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation, 17(5), 443-450.
6. De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010;66(5):986-990.
7. Bara B, Schu S, Vesper J. First results of Burst high frequency stimulation in failed FBSS stimulation patients. One year follow up. Neuromodulation. 2013;16(5):e136.
8. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World neurosurgery. 2013;80(5):642-649.e641.
9. Espinet A, Courtney P, Mitchell B, et al. Burst spinal cord stimulation provides superior overall pain relief compared to tonic stimulation. Pain practice: the official journal of World Institute of Pain. 2014;14(s1):114.
10. De Vos CC, Bom MJ, Vanneste S, Lenders MW, de Ridder D. Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014;17(2):152-159.
11. Courtney P, Espinet A, Mitchell B, et al. Improved Pain Relief With Burst Spinal Cord Stimulation for Two Weeks in Patients Using Tonic Stimulation: Results From a Small Clinical Study.  Neuromodulation. 2015;18(5):361-366.
12. De Ridder D, Lenders MW, De Vos CC, et al. A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. Clinical Journal of Pain. 2015;31(5):433-437.
13. Tjepkema-Cloostermans MC, de Vos CC, Wolters R, Dijkstra-Scholten C, Lenders MW. Effect of Burst Stimulation Evaluated in Patients Familiar With Spinal Cord Stimulation. Neuromodulation. 2016;19(5):492-497.
14. Colini-Baldeschi G, De Carolis G, Papa A, et al. Burst stimulation for chronic low back and leg pain. 8th World Congress of the World Institute of Pain; 2016; New York, USA.
15. Kretzschmar M, Vesper J, Van Havenbergh T, et al. Improved pain and psychosocial function with Burst SCS: 1 year outcomes of a prospective study. Neuromodulation. 2017;20(7):e450.
16. Kinfe TM, Muhammad S, Link C, Roeske S, Chaudhry SR, Yearwood TL. Burst Spinal Cord Stimulation Increases Peripheral Antineuroinflammatory Interleukin 10 Levels in Failed Back Surgery Syndrome Patients With Predominant Back Pain. Neuromodulation: Technology at the Neural Interface. 2017;20(4).
17. Wahlstedt A, Leljevahl E, Venkatesan L, Agnesi F. Cervical burst spinal cord stimulation for upper limb chronic pain: A retrospective case series. Poster presented at 16th Annual Pain Medicine Meeting; 2017; Lake Buena Vista, FL.
18. Muhammad S, Roeske S, Chaudhry SR, Kinfe TM. Burst or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data. Neuromodulation. 2017.
19. Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2020 Mar 23. doi: 10.1111/ner.13143. Epub ahead of print. PMID: 32202044. 
20. Saber, M. Schwabe, D. et al 2018, Rat fMRI brain responses to noxious stimulation during tonic, burst, and burst-microdosing spinal cord stimulation. NANS summer series; 2018; New York, NY.
21. Kriek, Nadia, et al. Preferred frequencies and waveforms for spinal cord stimulation in patients with complex regional pain syndrome: a multicenter, double-blind, randomized and placebo-controlled crossover trial. European Journal of Pain. 2017;21(3):507-519.
22. Byrne, JH. Analysis of synaptic depression contributing to habituation of gill-withdrawal reflex in Aplysia californica. Journal of Neurophysiology. 1982:48(2):431-438.
23. Bocci T, De Carolis G, Paroli M et al. Neurophysiological comparison among tonic, high frequency, and burst spinal cord stimulation: novel insights into spinal and brain mechanisms of action. Neuromodulation 2018;21:480–488.
24. Grider, Jay S., and Michael Harned. "Cervical Spinal Cord Stimulation Using Monophasic Burst Waveform for Axial Neck and Upper Extremity Radicular Pain: A Preliminary Observational Study." Neuromodulation: Technology at the Neural Interface (2019).
25. Pope, Jason E., et al. “Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study.” Neuromodulation: Technology at the Neural Interface (2019).
26. Abbott. Proclaim™ XR SCS system Instructions for Use. Plano, TX. 2019.

MAT-1900007 v1.0

IMPORTANT SAFETY INFORMATION

Spinal Column Stimulation (SCS)

PRESCRIPTION AND SAFETY INFORMATION

Read this section to gather important prescription and safety information.

INTENDED USE

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. 

CONTRAINDICATIONS

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 medical.abbott/manuals). For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/MRI-ready

WARNINGS

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.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.

Explosive and flammable gases. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

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.

Device modification. 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

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken).

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.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

PRECAUTIONS

The following precautions apply to this neurostimulation system.

General Precautions

  • 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.
  • Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components.
  • Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.
  • 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).
  • Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.
  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

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.
  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.
  • 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.
  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.
  • 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.

Hospitals 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.

Home and Occupational Environments

  • 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. 

ADVERSE EFFECTS

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.)
  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure
  • Stimulation in unwanted places (such as radicular stimulation of the chest wall) 
  • Lead migration, causing changes in stimulation or reduced pain relief 
  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space 
  • Cerebrospinal fluid (CSF) leakage 
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 
  • Persistent pain at the electrode or 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

 

MAT-2006973 v2.0

 

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