New retrospective data evaluating the Boston Scientific Corporation (NYSE: BSX) Precision Spectra™ Spinal Cord Stimulator (SCS) System demonstrate that the device provided sustained, highly significant relief of low back pain 12 months after implantation. Results from the PRO Study were presented 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. The system's Illumina™ 3D Software, an anatomy-driven computer model designed for simple point-and-click pain targeting, helps to address a key challenge in long term back pain relief: stimulating the neural target without stimulating undesired areas.
At 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.
- This cohort will be followed through the 24-month interval.
"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."
"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."
Together with the clinical data presented at NANS, additional presentations will describe an advanced research program of investigational studies of Boston Scientific SCS systems. These studies include ACCELERATE, a prospective multicenter trial evaluating conventional high-rate (10 kHz) spinal cord stimulation in the management of chronic, intractable pain, and WHISPER, a prospective multicenter trial evaluating the use of sub-perception multiple independent current control (MICC) SCS at up to 1.2 kHz.
About Chronic Pain
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 relief, or the hope for relief, many patients lose the ability to sleep, work and function normally. In particular, conventional spinal cord stimulator therapy can be effective in treating low back pain but not all patients get optimal relief. As a result, there is a continuing need for new therapies and technologies to meet this very specific pain area.
About the Precision Spectra SCS System
Recently, Popular Mechanics magazine awarded the Precision Spectra System the 2014 "Breakthrough Award" in the field of medical devices for its innovation in meeting the needs of patients with chronic pain.The 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. Prior to the release of the Precision Spectra SCS System, SCS systems offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of a single lead. Additional lead ports give physicians more flexibility to cover their patients' pain at the time of implant and more flexibility to adapt to changing pain patterns in the future. With more contacts, the Precision Spectra SCS System also offers more coverage of the spinal cord for the management of chronic pain.
The upgradeable Precision Spectra SCS System is 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.