NATICK, Mass., April 12, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received approval by the U.S. Food and Drug Administration and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. The Precision Spectra System is the world's first and only SCS system with Illumina 3D™ software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. Boston Scientific, the United States market leader in rechargeable SCS devices exiting 2012, is introducing the system at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale, Florida. Images of the Precision Spectra System can be downloaded here.
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.
Spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts in order to mask pain signals traveling to the brain. The Precision Spectra System features Illumina 3D software designed to improve control of the stimulation field. The software is based on a proprietary computer model that takes into account 3D anatomical structures, including the conductivity of the spinal cord and surrounding tissue. The physician simply selects a desired location on the spinal cord and the programming software creates a customized stimulation field to mask the patient's pain.
"The Precision Spectra System represents a paradigm shift in spinal cord stimulation," said Giancarlo Barolat , M.D., medical director of Barolat Neuroscience in Denver. "The Illumina 3D Software is the first SCS programming technology based on advanced anatomical and scientific principles. When combined with 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra technology gives physicians more flexibility to customize therapy for patients."
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. 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 System also offers more coverage of the spinal cord for the management of chronic pain.
"The Precision Spectra System is a major milestone in the advancement of SCS therapy," said Maulik Nanavaty , president of the Neuromodulation business unit at Boston Scientific. "The launch of the Precision Spectra System demonstrates our commitment to bringing meaningful innovations to market that provide more pain relief to a broader spectrum of patients."
INVESTMENT IN CLINICAL STUDIES, NEW PRODUCTS AND INDICATIONS
Boston Scientific expects to make continued investments in clinical studies to further understand the needs of chronic pain patients and has recently begun the following trials:
- OPTIONS Trial: An ongoing prospective, multi-center, single-arm study to further characterize the benefits of having a 32-contact option using the Precision Spectra System.
- MAP Trial: An ongoing cross-sectional, multicenter study to estimate the prevalence of multiple areas of pain in SCS-eligible patients with certain diseases.
In addition to the Precision Spectra System, Boston Scientific has recently launched multiple new products in Europe and the United States, and has received expanded indications in Europe:
- Head-only MRI Conditional CE Mark Approval for the Precision™ Plus SCS System (in the U.S., this is not available for use or sale)
- Peripheral Nerve Stimulation CE Mark Approval for the Precision Plus SCS System (in the U.S., this is not available for use or sale)
- Vercise™ Deep Brain Stimulator System CE Mark approval for Parkinson's Disease (in the U.S., this is an investigational device and not available for sale)
- Infinion™ 16 Percutaneous SCS Lead with U.S. FDA and CE Mark approval