Boston Scientific Announces FDA Approval Of New Leads For The Precision Plus™ Spinal Cord Stimulator System

Main Category: Back Pain
Also Included In: Neurology / Neuroscience;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 30 Jul 2010 - 1:00 PDT

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Boston Scientific Corporation (NYSE: BSX) announced U.S. Food and Drug Administration approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus™ Spinal Cord Stimulator System, the world's first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs. The Linear™ 3-4 and Linear™ 3-6 Percutaneous Leads offer wider contact spacing to expand the lead choices available to physicians. The Company plans to launch the products immediately in the U.S.; they were launched in Europe and other international markets earlier this year.

SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain. The new leads, in combination with the recently launched W4 and D4 lead splitters, provide the broadest range of percutaneous lead configurations in the industry.

"I have had great results using Boston Scientific's Linear Lead with tight contact spacing for my chronic pain patients," said Stephen Pyles, M.D., of the Florida Pain Clinic in Ocala, Florida. "When I want wider contact spacing, these new leads provide that option."

"Our products are designed to meet the unique clinical demands of SCS pain patients," said Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division. "The approval of these products expands our portfolio of leads for the Precision Plus System, offering pain management physicians more choices to help optimize pain relief for their patients."

Pain is the most common reason Americans seek medical treatment, and many chronic pain patients have found that SCS helps them manage their pain and live better lives.

About Boston Scientific Neuromodulation

Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology. The Precision Plus™ Spinal Cord Stimulator System, powered by SmoothWave™ Technology, uses pulses of electricity delivered directly along nerve fibers through the spinal cord to mask pain signals to the brain. Through its investments in technology, clinical science and world-class service, Boston Scientific Neuromodulation is committed to Making life smoother™ for physicians and patients.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our 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.

Source: Boston Scientific Corporation

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