Boston Scientific has received CE mark approval and has begun the European market launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. The system is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.
According to the company, the Precision Spectra System is the world’s first and only SCS system with 32 contacts and 32 dedicated power sources. The first commercial implant of the Precision Spectra System was performed in November 2012 by Simon Thomson, consultant in Pain Medicine and Neuromodulation, Basildon and Thurrock University Hospitals, UK.
Designed to manage chronic pain, spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals traveling to the brain. Until now, SCS systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. By providing 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain. Additional lead ports also give physicians more flexibility to treat their patients’ pain at time of implant and more flexibility to adapt to changing pain patterns in the future.
“Over the past 30 years, SCS systems have evolved from four to eight to 16 contacts. At each step, we have seen an improvement in our ability to cover pain,” said Thomson. “Now, by doubling the number of contacts to 32 while providing a dedicated power source for each contact, the Precision Spectra System advances our ability to provide pain relief.”
Boston Scientific plans to make significant investment in several clinical trials and build upon its current portfolio of chronic pain management and neuromodulation solutions.
The company has recently begun the following trials:
- OPTIONS trial: A prospective, multicentre, single arm study to further characterise the benefits of having a 32 contact option using the Precision Spectra System.
- MAP trial: A cross-sectional, multicentre study to identify the prevalence of multiple areas of pain in SCS-eligible patients with certain diseases.
The Precision Spectra SCS System is currently under review by the US Food and Drug Administration, and is not available for sale in the United States.