Spinal Cord Stimulation (SCS) clinical data

Advancing clinical leadership in spinal cord stimulation therapy

Unmatched clinical data supporting SCS

Boston Scientific’s multiple mechanism SCS therapy is proven by 4 Level I RCTs and 4 Real-world Studies.1-9

View the 4 Level 1 RCTs and 4 Real-world studies.

Every minute counts on the journey to pain relief. Time Matters. Why Wait?

Discover the latest clinical data supporting FAST™ Therapy

Boston Scientific’s proprietary FAST Therapy provides rapid and profound paresthesia-free pain relief in minutes that lasts for years.  

2 minutes to pain relief10,11†

2 pain score11,12,13†

2-year outcomes12,13,14

†Disclaimer: These outcomes reflect approximated data as determined in the referenced studies.

Give your patients another option if their SCS therapy is no longer effective

Boston Scientific’s Multiple Mechanism Therapy enables: 

60% trial salvage15

60% implant salvage16

View our robust clinical data

Provide your patients with personalized SCS treatments that are backed by strong clinical evidence.

Access the 4 Level I RCTS

PROCO RCT1

With proper neural dosing, 1kHz provides excellent pain relief using less energy

WHISPER RCT3

Patients achieve superior outcomes when they can choose between multiple options: sub-perception AND paresthesia

COMBO RCT5

Boston Scientific’s proprietary Combination Therapy (Contour + Paresthesia) delivers high clinical and functional success that is sustained for years

SOLIS RCT8

SCS with multiple modalities delivers high clinical and functional success in NSBP patients that is sustained for years

Access the 4 Real-World Studies

HALO STUDY2

The Contour™ Algorithm at 200 Hz delivers Simple, Efficient, and Effective sub-perception pain relief 

LUMINA STUDY4

Using Boston Scientific’s Illumina 3D™ Algorithm, paresthesia-based SCS provides excellent pain relief

WAVEWRITERTM STUDY6


WAVEWRITERTM STUDY7

Boston Scientific’s WaveWriter System delivers excellent durable outcomes in the real-world

RELIEF NSBP REGISTRY9

Boston Scientific’s global RELIEF registry confirmed high responder rates and patient satisfaction from the SOLIS RCT in the real-world out to 2-years

REFERENCES:

  1. Thomson SJ, Tavakkolizadeh M, Love-Jones S, et al. Effects of rate on analgesia in kilohertz frequency spinal cord stimulation; results of the PROCO randomized controlled trial. Neuromodulation. 2018;21(1):67-76. (n=20)
  2. Paz-Solis J. Thomson S, Jain R. Chen L, Huertas I, Doan Q. Exploration of high- and low-frequency options for subperception spinal cord stimulation using neural dosing parameter relationships: the HALO study. Neuromodulation, 2022;25(1):94-102. (n=30)
  3. North J, Loudermilk E, Lee A, et al. Outcomes of a multicenter, prospective, crossover, randomized controlled trial evaluating subperception spinal cord stimulation at ≤1.2 khz in previously implanted subjects. Neuromodulation. 2020:23(1):102-108. (n=140)
  4. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3d) neural targeting shows superior chronic axial low back pain relief compared to traditional scs-lumina study. Pain Med. 2017;18(8):1534-1548. (n=169)
  5. Wallace MS, North JM, Phillips GM, et al. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023:13(3):171-184. (n=59)
  6. Metzger CS, Hammond MB, Pyles ST, et al. Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes, Expert Rev Med Devices. 2020;17(9):951-957. (n=84)
  7. Metzger C, et al. Long-Term Chronic Pain-Relief Outcomes Using an SCS System Capable of Combination Therapy (WaveWriter Outcomes Study] [Abstract]. Twenty-fifth Annual Meeting of the North American Neuromodulation Society, January 13-15th, 2022. (n=84)
  8. North J., et al. Evaluating SCS and Medical Management for Chronic Pain Without Prior Surgery: SOLIS RCT 24-Month Outcomes [Abstract], NANS 2025 Annual Meeting, Jan 30- Feb l, 2025. (n=77)
  9. Rauck R. et al. Real-World Outcomes Using Spinal Cord Stimulation for Treatment of Chronic Back Pain with No Prior Back Surgery [Abstract 88). Third joint Congress of the INS European Chapters, August 31-September 2nd, 2023, (n=48)
  10. Gage E., et al. Rapid Onset of Analgesia during Trial Period Utilizing Fast-Acting Sub-Perception Therapy SCS [Abstract] NANS 2023 Annual Meeting, Jan 12-15, 2023. (n=44)
  11. Anitescu M., et al. Utilizing SCS Designed to Engage Surround Inhibition Using Fast-Acting Sub-Perception Therapy  (FAST): Prospective, Multicenter, Long-Term Outcomes [Abstract] NANS 2025 Annual Meeting, Jan 30-Feb 1, 2025. (n=20)
  12. Metzger C., et al. Two-year Outcomes Using Fast-Acting Sub-perception Therapy for Spinal Cord Stimulation: Results of a Real-World Multicenter Study in the United States. Expert Rev Med Devices. Published online January 2025. (n=50)
  13. Bayerl S, Paz-Solis J, Matis G, et al. Two-year outcomes using fast-acting, sub-perception therapy for spinal cord stimulation: a European, real-world, multicenter experience. JCM. 2024;13(22):6999. (n=52)
  14. Ferro R. et al. Streamlining Spinal Cord Stimulation Therapy via Personalized Automation of Programming [Abstract] NANS 2025 Annual Meeting, Jan 30-Feb 1, 2025. (n=23)
  15. Haider N, Ligham D, Quave B, et al. Spinal cord stimulation (SCS) trial outcomes after conversion to a multiple waveform SCS system. Neuromodulation. 2018:21(5):504-507.  (n=16)
  16. Rigoard P. Billot M. Bougeard R, et al. Improved outcomes and therapy longevity after salvage using a novel spinal cord stimulation system for chronic pain: multicenter, observational, European case series. J Clin Med. 2024;13(4):1079. (n=43)

*Sub-perception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia inducing stimulation for at least six months. Full stimulation parameter ranges and options for both paresthesia-based and sub-perception therapy are available for clinician's use throughout the patient's experience and treatment with SCS. 

US Indications for Use: The Boston Scientific Spinal Cord Stimulator Systems are 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, Complex Regional Pain Syndrome (CRPS) Types I and II, Diabetic Peripheral Neuropathy of the lower extremities, intractable low back pain and leg pain, radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.  Contraindications, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. Refer to the Instructions for Use provided with the SCS System or Pain.com for potential adverse effects, warnings, and precautions prior to using this product.

Warning: Stimulation modes. Only paresthesia-based stimulation mode has been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.