A small dose for a big impact.

BOLDXR™ DOSING PROTOCOL EXCLUSIVELY FOR BURSTDR™ STIMULATION

A SMALL DOSE FOR A BIG IMPACT.Medications are dosed. Now you can dose stimulation in the same way.

O P T I M A L D O S E

BE CONFIDENT IN THE THERAPEUTIC WINDOW.

T I M E

THE

RA

PE

UTI

C E

FFE

CT

Dosing stimulation can maintain therapeutic effect while lowering risk of overstimulation.1

S U B T H E R A P E U T I C

S I D E E F F E C T

BoldXR™

DOSING PROTOCOL

The world’s first standardized electronic dosing protocol for BurstDR™ stimulation designed to improve the patient experience.1,20

PROGRAMMING

THERAPY LONGEVIT Y

BAT TERY LIFE

Simple and effective programming that identifies the lowest therapeutic dose without sacrificing therapy effectiveness.1

Dosing BurstDR™ stimulation may uniquely address therapy longevity by reducing stimulation on-time.1,2

Dosed programming extends battery life, allowing more patients to live recharge-free.21

BurstDR stimulation’s unique and proprietary waveform characteristics have an observed carry-over effect,3 allowing it to be dosed without sacrificing efficacy.1

Lateral Pathway Medial PathwayB U R S T D R ™ S T I M U L AT I O N

BurstDR™ stimulation is uniquely dosable.

powerful enough for small doses.

A PROVEN WAVEFORM BurstDR stimulation proved superior* to tonic stimulation in a large randomized controlled trial. And for over eight years BurstDR stimulation continues to produce CONSISTENT, SUPERIOR* and REPLICABLE results in diverse clinical settings around the world.4-18

6 RANDOMIZED CONTROLLED TRIALS4-18

3 PLACEBO CONTROLLED TRIALS4-18 3

CONTINENTS8+YEARS

600+PATIENTS

13+STUDIES

OF PEOPLE PREFER BURSTDR™

STIMULATION TO TONIC+

+87%

Passive Discharge Phase Non-linear Charge Accumulation Phase

B O L DX R ™ D O S I N G P R O T O C O L

The world’s first standardized electronic dosing protocol for BurstDR™ stimulation designed to improve the patient experience.1,20

n=24

ON-TIME /DAY

6 HOURS OR LESS3.4 HOURS OR LESS

1.8 H

OURS OR LESS

100% of patients receiving clinically relevant pain relief with dosed settings.

66% of patients use less than 4 hours of stimulation per day.

43% of patients utilizing program with lowest dose setting.

100%

BASED ON THE BOLD STUDY 1 Dosing results in patients receiving minimal stimulation while maintaining therapeutic effect.

66%

43%

MAKE THE BOLD CHOICE.

Join the low-energy revolution.Talk to your Abbott Representative about the BoldXR™ dosing protocol, exclusively for BurstDR stimulation.

References

Rx Only

1. Deer, T. (2019). Efficacy of Burst Spinal Cord Stimulation Microdosing in a De-Novo Patient: Preliminary Analysis. Presented at NANS 2019.

2. Byrne, J.H., 1982. Analysis of synaptic depression contributing to habituation of gill-withdrawal reflex in Aplysia californica. Journal of Neurophysiology, 48(2), pp.431-438.

3. 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.

4. 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. 0;46:489–11. doi:10.1111/ner.12698.: 1-2.

5. 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.

6. 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.

7. 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.

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. Espinet A, Courtney P, Mitchell B, et al. Burst spinal cord stimulation provides su-perior 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, 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

20. Memo on file. SJM-BDR-0219-0096.

21. St. Jude Medical™ Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

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.

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

*Superiority when compared to traditional tonic SCS in SUNBURST.

+Indicates reference numbers 4, 5, 7, 8, 11, 13, 14, 19

Brief Summary: Prior to using these devices, please review the Clinician’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. Indications for Use: Spinal cord stimu-lation 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). Clinician’s Manual must be reviewed for detailed disclosure.

Abbott One St. Jude Medical Dr. St. Paul, MN 55117 USA Tel: 1 651 756 2000 Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third party trademark, which is property of its respective owner.

© 2019 Abbott. All Rights Reserved.

32386-SJM-BDR-0219-0095 Item approved for global use.