Boston Scientific Reports Favorable Results Assessing Real-World Experience with the Precision Spectra™ Spinal Cord Stimulator System
Dec 06, 2013
New Retrospective Data Presented at NANS 2013 Show Highly Significant Reduction in Pain and High Trial Therapy Success Rate of Precision Spectra in the Treatment of Chronic Pain
New retrospective data highlighting the Boston Scientific Corporation (NYSE: BSX) Precision Spectra™ Spinal Cord Stimulator (SCS) System demonstrate the device provided highly significant pain relief three months after implantation. Results were presented at the North American Neuromodulation Society (NANS) 17th annual meeting in Las Vegas.
Precision Spectra is the first SCS System designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. By providing 32 contacts – twice the number of contacts available with other SCS systems – the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain.
The retrospective study of up to 213 consecutive patients at 13 centers focused on patients with chronic pain who were treated with the Precision Spectra SCS System. Results include:
- A 94 percent SCS trial therapy success rate (n=213)
- A highly significant reduction in pain from an average baseline score of 7.8, on a 10-point scale, to an average score of 3.2 at three months post implant (in the patients who have reached the three-month follow up, n=113)
- A highly significant reduction in low back pain from an average baseline score of 7.0, on a 10-point scale, to an average of 2.9 at three months post implant (in the low back pain patients who have reached the three-month follow up, n=32)
- Early results indicate improvements in function, including walking and sleeping, in addition to reductions in opioid use and disability
"The primary objective of SCS is pain relief," said Salim Hayek, M.D., Ph.D., chief, Division of Pain Medicine at University Hospitals of Cleveland. "These initial results indicate that the Precision Spectra System is effectively reducing pain in these real-world patients at three months post implant."
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 pain relief, or the hope for relief, many patients lose the ability to sleep, work, and function normally. Spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These contacts provide pain relief by masking pain signals traveling to the brain.
"Boston Scientific is committed to advancing science to improve pain relief," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "These data are very promising and we look forward to the results of our ongoing clinical programs to demonstrate the long term benefits of the Precision Spectra SCS System."
These results are part of a robust clinical program that has been established to further characterize the benefits of the Precision Spectra System in providing pain relief. Other initiatives include RELIEF, a global registry for long term assessment of neuromodulation therapy for pain, and OPTIONS, a prospective, multi-center study of the Precision Spectra System.
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 markets for our products, our business plans, clinical trials, product performance 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.