Advanced Illumina™ 3D Programming Software Provides Highly Significant Pain Relief in Study Patients
New retrospective data highlighting the Boston Scientific Corporation (NYSE: BSX) Precision Spectra™ Spinal Cord Stimulator (SCS) System demonstrate the device provided sustained and highly significant relief of low-back pain six months after implantation. Results were presented at the World Institute of Pain (WIP) 7th World Congress in Maastricht, The Netherlands May 7-10, 2014.
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. A key challenge in SCS therapy is stimulating the neural target without stimulating undesired areas. By taking into account the conductivity of 3D anatomical structures and physician placement of the SCS leads, the Illumina 3D Software is designed for simple point-and-click pain targeting.
The retrospective study of 213 patients at 13 centers is focused on patients with chronic pain who were treated with the Precision Spectra SCS System. To date, 140 patients have reached six months post-implant. Results include:
- Sustained and highly significant reduction in pain from an average baseline score of 7.15, on a 10-point scale, to an average score of 2.93 at six months post-implant (n=140).
- In those patients with only low-back pain (N=62), sustained and highly significant reduction of low back pain, from an average baseline score of 7.53, on a 10-point scale, to an average of 3.45 at six months post-implant.
- In those patients with severe low back pain (N=38, baseline score of 8 or greater on a 10-point scale), sustained and highly significant reduction in pain, from an average score of 8.78 at baseline to 3.68 at 6 months post-implant.
"The goal of SCS is sustained pain relief, and individuals with chronic back pain are among the most difficult to treat," said Salim Hayek, M.D., Ph.D., chief, Division of Pain Medicine at University Hospitals of Cleveland. "In this study, these retrospective results demonstrate that the Precision Spectra System is maintaining effective therapy for these challenging patients out to six months post-implant."
Boston Scientific also initiated the full European launch of the Precision Spectra Clinician Programmer, a mobile, touchscreen tablet powered by an Intel® Core™ i5 Processor.1 The new Precision Spectra Clinician Programmer provides clinicians with a sleek, powerful and easy-to-use device to drive the advanced Illumina 3D Software.
Chronic pain affects 95 million people in Europe and more than 100 million people in the United States.2,3 Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. 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. 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.
"Boston Scientific specifically developed the Precision Spectra System to achieve better therapy outcomes," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "These six-month results demonstrate our dedication to improving the lives of patients with chronic pain through meaningful innovation. We look forward to the long-term outcomes of this ongoing clinical study."
The clinical data presented at WIP are part of a robust clinical program that has been established to characterize further 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.
In 2004, Boston Scientific launched the world's first rechargeable SCS device, the Precision™ System, which was also the world's first 16-contact implantable SCS device. Today, more than 60,000 patients worldwide have been treated using a Boston Scientific SCS System. When compared to non-rechargeable SCS systems, rechargeable SCS devices may offer clinical benefits by extending therapeutic longevity and therefore avoiding frequent replacement surgeries and complications that may arise from repeated surgeries.
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, new product launches, clinical trials and impact, 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.