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.
BurstDR™ stimulation is a unique and proprietary waveform that mimics natural firing patterns in the brain.2 The unique characteristics of the waveform create a powerful signal that modulates both the medial and lateral pathways in the brain.3 This unique mechanism of action gives patients relief from both the physical pain and the emotional symptoms† of pain.3
The Proclaim XR SCS System harnesses the power of low-energy BurstDR stimulation, coupled with the BoldXR dosing protocol, to extend battery life and provide pain relief without the hassle of recharging.1
The BoldXR dosing protocol:
Based on the bold clinical study, at 6 months:1
100% of patients remained on dosed settings using 6 hours or less of stimulation per day.
Nearly 50% of patients remained on the lowest dose setting using only 1.8 hours of stimulation per day.
Dosed BurstDR stimulation:
Meaningful relief from chronic pain. Free from the hassles of recharging.
At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging.
Based on charging 1 hour per day, every day for up to 10 years for a total of 3,648 hours.
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.
Talk to your Abbott representative for more information.
The Proclaim XR SCS SYSTEM BACKED BY THE BOLD GUARANTEE:
Up to 10-year battery life at low-dose settings**
Freedom from the hassles of recharging
Superior* BurstDR stimulation therapy3
Familiar Apple‡ devices
Full-body MR conditional labeling***
Backed by an industry-leading 5-year battery-life warranty
* *BurstDR™ stimulation superiority when compared to traditional tonic stimulation as studied 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.
***Within approved parameters. Refer to the Instructions for Use for full details on the MR conditional scan parameters.
†Pain and suffering as measured by VAS.
1. Deer T. (2019). Efficacy of Burst Spinal Cord Stimulation Microdosing in a De-Novo Patient. Poster presented at NAPA Pain 2019.
2. 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.
3. 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.
4. Saber M, Schwabe D, et al. Rat fMRI brain responses to noxious stimulation during tonic, burst, and burst-microdosing spinal cord stimulation. NANS summer series; 2018; New York, NY.
5. 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.
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. 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.
8. Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014;17(5):443-450.
9. 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.
10. 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.
11. Deer T, et. al. Randomized, Controlled Trial Assessing Burst Stimulation for Chronic Pain: Two-year Outcomes from the SUNBURST Study. Poster presented at North American Neuromodulation Society Meeting; 2018; Las Vegas, NV.
12. 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.
13. 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.
14. 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.
15. Kriek N, 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. 21.3 (2017): 507-519.
16. 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.
17. 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).
18. 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.
19. 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.
20. 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.
21. Memo on file. SJM-BDR-0219-0096.
22. Byrne JH. (1982). Analysis of synaptic depression contributing to habituation of gill-withdrawal reflex in Aplysia californica. Journal of Neurophysiology. 48(2), pp.431-438.
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.
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.
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.
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:
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.
The following precautions apply to this neurostimulation system.
Sterilization and Storage
Handling and Implementation
Hospitals and Medical Environments
Home and Occupational Environments
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG: