Boston Scientific Spinal Cord Stimulator Receives CE Mark
Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of its Precision Spectra Spinal Cord Stimulator (SCS) System. The system has 32 contacts and 32 dedicated power sources, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic back pain. The first commercial implant of the Precision Spectra System was performed in November this year by Simon Thomson, M.D., a consultant in pain medicine and neuromodulation, at the Basildon and Thurrock University Hospitals in the United Kingdom.
Chronic pain affects one in five adults in Europe, or about 95 million people 15 to 64 years of age. 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.
Spinal cord stimulators are designed to manage chronic pain by delivering electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals traveling to the brain. Until now, according to Boston Scientific, SCS systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. Precision’s 32 contacts and four lead points offer more coverage of the spinal cord. Also, the additional lead ports 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, claims the company.
“Over the past 30 years, SCS systems have evolved from four to eight to 16 contacts,” said Thomson. “At each step, we have seen an improvement in our ability to cover pain. 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 is headquartered in Natick, Mass., while its neuromodulation business is located in Valencia, Calif. The company plans to make “significant investment” in several clinical trials to beef up its current portfolio of chronic pain management and neuromodulation solutions. Already in progress are two trials: The Options Trial to characterize the benefits of a 32 contact option using the Precision Spectra System; and the Map Trial which is working 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 U.S. Food and Drug Administration, and is not available for sale in the United States.