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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, markets for our products, clinical trials and data impact, product performance and impact, and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Boston Scientific Corporation
Susie Lisa, CFA
Boston Scientific Corporation
SOURCE Boston Scientific Corporation