MARLBOURGH, Massachusetts,
June 10, 2015 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) presented new data demonstrating
that the Precision Spectra™ Spinal Cord Stimulator (SCS)
System provided 1.5 times better overall pain relief and 2 times
better low back pain relief than the previous generation Precision
Plus™ SCS system. The improved outcomes with the Precision Spectra
System were achieved in conjunction with the use of the proprietary
Illumina™ 3D neural targeting software, designed to target pain
with point-and-click simplicity. Results from the LUMINA cohort of
the Precision Spectra System observational study were presented
this week at the International Neuromodulation Society 12th World
Congress in Montreal, Canada.
The LUMINA cohort includes three patient groups: 213
consecutive patients treated with the Precision Spectra System for
up to 24 months post-implant; 130 consecutive patients treated with
the previous generation system, Precision Plus™, in a comparative
evaluation with the Precision Spectra System; and 25 consecutive
patients treated with the Precision Spectra System and the new
CoverEdge 32 Surgical Leads for up to 6 months post-implant.
"The results are exciting because we looked at consecutive
patients – some with only low back pain – in a real-world setting,"
said Julie Pilitsis, M.D., Ph.D.,
associate professor, Albany Medical
College and one of the lead investigators for this study.
"This is strong clinical evidence of the effectiveness of the
Precision Spectra System in treating the types of challenging
chronic pain patients that physicians see every day."
Key findings of the study included:
LUMINA Spectra group:
- Sustained and highly significant reduction in overall pain from
an average baseline score of 7.17 to 2.98 at 24 months post-implant
(N= 117), as measured on the 0-10 numeric rating scale (NRS)
- In a subset of patients with only low back pain (N=51), a
sustained and highly significant reduction from an average baseline
score of 7.21 to 3.20 at 24 months post-implant
- Significant reduction in disability (N=51), maintained out to
12 months, as measured by the Oswestry Disability Index.
- Comparison between the Precision Spectra and Precision Plus
Systems groups:
- Responder rates (greater than or equal to 50% pain reduction)
at 12 months post-implant for the Precision Spectra System were 72%
for overall pain, 82% in leg pain only patients and 71% in low back
pain only patients. For low back pain, the improvement with Spectra
was more than twice that of the previous generation system group
(Precision Plus™).
LUMINA Surgical group:
- Highly significant reduction in overall pain from an average
baseline score of 7.7 to 2.7 at 6 months post-implant (N=23).
- In a subset of patients with only low back pain (N=9), 90%
responder rate and a highly significant reduction from an average
baseline score of 7.8 to 1.6 at 6 months post-implant.
"We designed the Precision Spectra SCS System to achieve even
better outcomes when treating low back pain," said Maulik Nanavaty, president, Neuromodulation,
Boston Scientific. "These real-world clinical data demonstrate that
the Precision Spectra System with our proprietary neural targeting
software is a significant scientific advancement in pain
management."
The LUMINA cohort is part of the Boston Scientific PRO
observational study.
About Chronic Pain
More than 100 million Americans suffer from chronic pain. Living
in constant pain for an extended period of time can have a
devastating impact on quality of life for many patients; without
relief, or the hope for relief, many patients lose the ability to
sleep, work and function normally. In particular, conventional
spinal cord stimulator therapy can be effective in treating low
back pain but not all patients get optimal relief. As a result,
there is a continuing need for new therapies and technologies to
meet this very specific pain area.
About the Precision Spectra SCS System
The Precision
Spectra SCS System is the first and only SCS system with Illumina
3D™ software and 32 contacts, and is designed to provide improved
pain relief to a wide range of patients who suffer from chronic
pain. Prior to the release of the Precision Spectra SCS System with
32 contacts, SCS systems offered a maximum of 16 contacts and two
lead ports, with each lead port allowing the placement of a single
lead. Additional lead ports give physicians more flexibility to
cover their patients' pain at the time of implant and more
flexibility to adapt to changing pain patterns in the future. With
more contacts, the Precision Spectra SCS System also offers more
coverage of the spinal cord for the management of chronic pain.
Popular Mechanics magazine awarded the Precision Spectra System the
2014 "Breakthrough Award" in the field of medical devices for its
innovation in meeting the needs of patients with chronic pain.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the
world. As a global medical technology leader for more than 35
years, we advance science for life by providing a broad range of
high performance solutions that address unmet patient needs and
reduce the cost of healthcare. For more information, visit
www.bostonscientific.com and connect on Twitter and Facebook.
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CONTACT:
Nisha Deo
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External Communications
Boston Scientific Corporation
Nisha.Deo@bsci.com
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Boston Scientific Corporation
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