Data Show Boston Scientific SCS System is Effective Six Months After Implantation

Boston Scientific Corp.’s Spectra Spinal Cord Stimulator System can provide sustained and significant relief of low back pain six months after it is implanted, according to data presented at the recent World Institute of Pain Congress (WIP) in The Netherlands.

“Boston Scientific specifically developed the Precision Spectra System to achieve better therapy outcomes,” Maulik Nanavaty, president of Neuromodulation at Boston Scientific, said in a news release. “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.”

Precision Spectra is the first spinal cord stimulation (SCS) system designed to improve pain relief using the Illumina 3-D Software, a 3-D anatomy-driven computer model. Because it takes into account the conductivity of 3-D anatomical structures and physician placement of the SCS leads, the Illumina 3D software is designed for simple point-and-click pain targeting, the company claims.

The retrospective study presented at the meeting included 213 patients with chronic pain treated at 13 centers with the Precision Spectra SCS System. In patients with six-month follow-up, average pain reduction on a 10-point scale changed from 7.15 points at baseline to 2.93 points at six months after implantation. 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 six 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 of the Division of Pain Medicine at University Hospitals of Cleveland (Ohio). “In this study, these retrospective results demonstrate 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. The new Precision Spectra Clinician Programmer provides clinicians with a device to drive the Illumina 3-D Software.

Chronic pain affects 95 million people in Europe and more than 100 million people in the United States, according to industry data. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients, BostonScientific notes. 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.

The clinical data presented at WIP are part of a clinical program established to 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.

BostonScientific launched the world’s first rechargeable SCS device, the Precision System (also the first 16-contact implantable SCS device) 10 years ago. 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, the company contends.