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.