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Boston Scientific Receives European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System
By: PR Newswire
Dec. 7, 2012 03:30 AM
-- World's First and Only System with 32 Contacts and 32 Dedicated Power Sources is Designed to Provide Pain Relief to a Broad Spectrum of Chronic Pain Patients
NATICK, Massachusetts, Dec. 7, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval and has begun the European market launch of the Precision Spectra™ Spinal Cord Stimulator (SCS) System. The Precision Spectra System is the world's first and only SCS system with 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 pain. The first commercial implant of the Precision Spectra System was performed last month by Dr. Simon Thomson, 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.
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 Dr. 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."
"The Precision Spectra System is a major milestone in the advancement of SCS therapy," said Maulik Nanavaty, president of the Neuromodulation business at Boston Scientific. "Our innovation is focused on pain relief and the Precision Spectra System demonstrates our commitment to providing improved pain relief to a broader spectrum of chronic pain patients."
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:
In addition to the Precision Spectra System, the Boston Scientific Neuromodulation business has recently launched several new products and has received expanded regulatory indications for products approved in Europe. These include:
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.
About Boston Scientific Neuromodulation
In 2004, Boston Scientific launched the world's first rechargeable SCS device, the Precision System, which was also the world's first 16-contact implantable SCS device. Today, more than 60,000 patients worldwide have been treated using Boston Scientific SCS systems. When compared to non-rechargeable SCS systems, rechargeable SCS devices may offer clinical benefits by extending therapeutic longevity and therefore avoiding frequent replacement surgeries and complications that may arise from repeated surgeries.
About Boston Scientific
Cautionary Statement Regarding Forward-Looking Statements
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
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