Boston Scientific on Friday announced CE Mark approval and has launched its new spinal cord stimulator system in Europe. The Precision Spectra Spinal Cord Stimulator (SCS) System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources, according to Boston Scientific. It is designed to provide relief to a wide range of patients who suffer from chronic pain.
The first commercial implant of the Precision Spectra System was performed last month at the Basildon and Thurrock University Hospitals in the United Kingdom.
Chronic pain affects one in five adults in Europe – about 95 million people 15 to 64 years of age, Boston Scientific says.
Spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals traveling up the spinal cord to the brain. Until now, Boston Scientific said, such 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.
Officials at Boston Scientific say they plan to invest and expand their offerings in neuromodulation and for the treatment of chronic pain in a big way. The Natick, Mass.-based company with about 5,000 Minnesota employees has recently begun other clinical trials and has launched several new products in Europe.
The Precision Spectra SCS System is currently under review by the U.S. Food and Drug Administration, and is not available for sale in the United States.