CLINICAL DATA

Boston Scientific’s SCS therapy is backed by years of science and extensive clinical evidence. This includes three Randomized Control Trials (RCTs), two Real-world Studies, and one Prospective Registry study.
Extensive clinical evidence supports the design of Boston Scientific’s SCS therapy.

LEVEL 1 STUDIES

PROCO RCT1

With proper neural dosing, 1 kHz provides excellent sub-perception pain relief using less energy than higher frequencies.1 (n=20)
Proco RCT study chart

WHISPER RCT2

Multiple therapy options deliver superior outcomes in long-term implanted patients. (n=140)
Whisper RCT study chart
The WHISPER RCT studied a population of highly-disabled, previously-implanted pts (n=140) not typically studied in SCS RCTs.

COMBO RCT3

BSN is investing in the Level 1 COMBO RCT to demonstrate the value of combination therapy using Spectra WaveWriter.

REAL-WORLD STUDIES

Metzger WaveWriter Study4

WaveWriter delivers significant and sustained pain relief in the real world. (n=420)

LUMINA Study5

When delivered with the Illumina 3D™ Algorithm, paresthesia-based SCS provides excellent pain relief. (n=213)
Illumina 3D cross-section
3D anatomical model of the spinal cord.

PROSPECTIVE REGISTRY

RELIEF GLOBAL REGISTRY6

RELIEF registry with >1000 pts shows a low explant rate and a high rate of patient improvement. (n=1151)
  • Included previous generation BSN systems (Precision Plus, Precision Spectra)
  • 88% of patients reported improvement after 3 years
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References

  1. Thomson et al, PROCO RCT, Neuromodulation 2018.
  2. North et al., WHISPER RCT, Neuromodulation 2019.
  3. https://clinicaltrials.gov/ct2/show/NCT03689920
  4. Metzger et al, Outcomes Using an SCS Device Capable of Delivering Combination Therapy and/or Advanced Waveforms/Field Shapes, INS 2019.
  5. Veizi et al, LUMINA Study (n=213), Pain Medicine 2015.
  6. Rauck et al., RELIEF Registry (N=1151), NANS 2019.

*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, intractable low back pain and leg pain. Associated conditions and etiologies may be: 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. 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 risks, or are pregnant. Refer to the Instructions for Use provided with the SCS System or ControlYourPain.com for potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Outside of US Indications for Use: CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.

Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.

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