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.
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