Boston Scientific Corporation is pointing us at new retrospective data evaluating the Precision Spectra™ Spinal Cord Stimulator (SCS) System. The company says the study demonstrates that the device provided sustained, highly significant relief of low back pain 12 months after implantation.
Background
Boston Scientific says its Precision Spectra SCS System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, which is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. The software bit is described as an anatomy-driven computer model that can accurately target pain and in so-doing achieve stimulation of the neural target without stimulating undesired areas.
Results from the so-tagged PRO Study are being presented this weekend at the 18th North American Neuromodulation Society (NANS) meeting in Las Vegas
The outcomes review of 213 patients at 13 centers focuses on patients with chronic pain and chronic low back pain who are receiving treatment with the Precision Spectra SCS System. This cohort will be followed through the 24-month interval, but for now, 12 months post-implantation, results include:
- Sustained and significant reduction in overall pain measured on the 0-10 numeric rating scale (NRS) was reported, from an average baseline score of 7.17, to an average score of 2.96 at 12 months post-implantation (N= 178).
- In patients with only low back pain (N= 73), a sustained and significant reduction of low back pain (measured on the 0-10 NRS scale) was reported, from an average baseline score of 7.21 to an average of 3.17 at 12 months post-implantation.
- In patients with severe low back pain (N= 41, baseline score of 8 or greater measured on the 0-10 NRS scale), sustained and significant reduction in pain was reported, from an average score of 8.60 at baseline to 2.87 at 12 months post-implantation.
News of this study, perhaps unfortunately for its purveyor, follows that from another company in the field, Stimwave Technologies, which has just announced the commencement of the first ever sham-controlled study into neurostimulator-driven back pain relief, as reported here.
Investigator comments
“Treating low back pain has been challenging because so many therapies have had mixed results,” said Salim Hayek, M.D., Ph.D., chief, Division of Pain Medicine at University Hospitals of Cleveland and lead study investigator. “These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from this difficult to treat condition.”
Company comments
“When designing the next-generation Precision Spectra SCS System, we included new, innovative technologies with the goal of treating low back pain more effectively,” said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. “This long-term, ‘real-world’ study reflects our continuing commitment to advancing the science of pain relief to help achieve better outcomes for patients with chronic pain.”
Source: Boston Scientific Corporation, PR Newswire
published: December 12, 2014 in: Boston Scientific, Clinical Studies/Trials, Pain management