Clinical Data

Recent clinical studies show that the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System provides sustained and highly significant pain reduction at 2 years post-implant. The latest LUMINA Data on consecutive real world patients are summarized below:

Select a study to see the study details:

LUMINA SPECTRA GROUP

Observed highly significant pain relief maintained out to 24 months post-implant for all patients (n=169) and a subset with low back pain only (n=70).

LUMINA COMPARATIVE DATA

Precision Spectra is >70% more effective at treating low back pain than previous generation Boston Scientific SCS Systems.

LUMINA PRECISION SPECTRA GROUP

Long-Term Reduction in Back Pain and Disability with Anatomically-Guided Neural Targeting: Final Results of the Multicenter LUMINA Study

Frey et al., Long-Term Reduction in Back Pain and Disability with Anatomically-Guided Neural Targeting: Final Results of the Multicenter LUMINA Study, Presented at the North American Neuromodulation Society 19th Annual Meeting, Las Vegas, NV 2015.
Note: Clinical study results may not necessarily be indicative of clinical performance. Results in other studies may vary.

Purpose

Presenting outcome data from an observational, multi-center study of the Precision Spectra SCS System.

Methods

Observational study of 213 consecutive patients who underwent Precision Spectra trials at 13 sites.
Clinical outcomes were analyzed in terms of baseline and 24 month post-implant pain intensity (0-10 NRS), and responder rate (≥ 50% reduction in NRS score).
The number, configurations, and location of leads used during the permanent implant were also reported.
Clinical outcomes were assessed at end of trial, 3 months, 6 months, 12 months, and 24 months post-IPG implantation.

HIGHLIGHTS

Severe patients reported

greater pain relief.

In this study, severe patients reported a statistically significant difference of

5.34 points

between baseline pain and 24 months post-implant (p< 0.0001).

Overall Pain Relief

Patient cohort

Subjects were treated with the Precision Spectra SCS System for chronic, intractable pain of the back and/or legs.

Mean baseline pain intensity of all patients (n=213) was 7.17 (0-10 NRS).
Mean baseline pain intensity of severe patients (n=108) was 8.75 (0-10 NRS).

^{(figure 1)}

Results

At 24 months post-implant, patients (n=169) showed a highly significant reduction in pain intensity (p<0.0001) with a difference of 4.23 points between baseline pain (7.17) and 24 months post-implant (2.94). (Figure 1)
Severe patients (n=91) demonstrated an even greater improvement (p<0.0001) with a difference of 5.34 points between baseline pain (8.75) and 24 months post-implant (3.41). (Figure 1)
Trial-to-perm ratio was 86% in this cohort (184 out of 213 pts).
74% responder rate (≥50% NRS reduction).
A wide range of lead configurations was used, consistent with intended flexibility.
Lead placement for permanent implant procedures, based on location of the lead tip, was predominantly in the T6-T8 vertebral levels, capturing 82% of cases. (Figure 2)
Other clinical improvements reported by these patients included improvement in activities of daily living, sleep, and physical function.

Author Conclusions

Highly significant overall pain relief maintained out to 24 months post-implant.
High trial-to-perm ratio (86%).
Illumina 3D™ Algorithm is versatile and may be used for subjects with varying pain severities, pain locations, lead numbers and lead configurations.
Illumina 3D Algorithm had a 74% responder rate (≥50% NRS Reduction) for at least 24 Months

Low Back Pain Relief

Patient cohort

Real-world cohort — only requirement is on label treatment with the Precision Spectra SCS System for low back pain only. Low Back Pain only patients were a subset of the Overall Pain patients.

Mean baseline pain intensity of all low back patients (n=89) was 7.21 (0-10 NRS).
Mean baseline pain intensity of severe low back patients (n=49) was 8.60 (0-10 NRS).

HIGHLIGHTS

New observational data highlighting the Boston Scientific Precision Spectra Spinal Cord Stimulator (SCS) System demonstrate the device provided highly significant low back pain relief maintained out to 24 months post-implant.

Results

At 24 months post-implant, patients (n=70) showed a highly significant reduction in low back pain intensity (p<0.0001) with a difference of 4.12 points between baseline pain (7.21) and 24 months post-implant (3.09). (Figure 1)
Severe patients (n=38) demonstrated an even greater improvement (p<0.0001) with a difference of 5.62 points between baseline pain (8.60) and 24 months post-implant (2.98). (Figure 1)
71% responder rate (≥50% NRS reduction).

Author Conclusions

Highly significant low back pain relief maintained out to 24 months post-implant.
These results suggest that the novel anatomically-guided neural targeting algorithm, with the 32-contact Precision Spectra System, may provide previously-unattained clinical outcomes for low back pain.

LUMINA Comparative Data

Patient cohort

Comparative evaluation of responder rates at 24 months post-implant:

Precision Spectra Group included 213 consecutive patients that were trialed with Precision Spectra. 184 of them received the permanent implant, and 169 reached the 24-month follow up.
Precision™ Plus Group included 213 consecutive patients that were trialed with Precision Plus. 147 of them received the permanent implant, and 141 reached the 24-month follow up.
Consecutive cohort with propensity score matching to control for baseline differences (by site, diagnosis, pain severity, pain location, age, and gender).

Results

Comparative evaluation of responder rates at 24 months post-implant:

Responder rates (≥50% pain reduction) at 24 months post-implant for the Precision Spectra System were 74% for overall pain, 81% in leg pain only patients and 71% in low back pain only patients.
For low back pain, the improvement with Precision Spectra was more than 70% greater than the previous generation system group (Precision Plus™).

Author Conclusions

Neural Targeting SCS is a novel SCS variant based on anatomical placement of the stimulation field.
Pain relief with Neural Targeting SCS was >70% more effective for low back pain relief than with a previous generation (non-Neural Targeting) system.

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