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.

Lower the dose

Raise your expectations

The Proclaim XR recharge-free SCS system allows patients to achieve relief from chronic pain.

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 therapeutic window

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

A Proprietary WAVEFORM

THAT IS UNIQUELY
DOSABLE

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

Learn More

Unique Characteristics of BurstDR Stimulation

BoldXR™ Dosing Protocol

The world’s first standardized electronic dosing protocol for BurstDR stimulation1,21

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:

  • Provides simple and effective programming that identifies the lowest therapeutic dose.1
  • Is based on the BOLD clinical study which demonstrated that dosing BurstDR stimulation results in patients receiving minimal stimulation while maintaining therapeutic effect.1
  • May uniquely address therapy longevity by reducing stimulation on-time.1,22

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:

  • Delivered statistically significant reduction in pain.1
  • Led to improved quality of life.1

Introducing the

Proclaim XR SCS System

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.

Devices with one-hour recharge per day.

Make the

Bold Choice

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

Upgradeable platform

Full-body MR conditional labeling***

Backed by an industry-leading 5-year battery-life warranty


REFERENCES:

* When compared to traditional tonic stimulation.

**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.

Important Safety Information

SJM-PXR-0919-0037