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Boston Scientific Announces FDA Approval and Launch of Lead Splitters for the Precision Plusâ„¢ Spinal Cord Stimulator System

Thu, 06/24/2010 - 6:37am
Boston Scientific

NATICK, Mass., June 24 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration approval and launch of two spinal cord stimulation (SCS) lead splitters 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, back and/or limbs.  The W4 and D4 splitters each enable multi-site placement of up to four leads, which are designed to deliver electrical pulses to the spinal cord that mask pain signals to the brain.  The products will be introduced at the 12th annual meeting of the American Society of Interventional Pain Physicians (ASIPP), June 26 – 30 in Arlington, Virginia.

The new splitters offer a broader range of lead configurations and are designed to provide physicians more treatment options for their chronic pain patients.  

"Spinal cord stimulation is an important treatment option for chronic pain," said Giancarlo Barolat, M.D., Medical Director of Barolat Neuroscience in Denver.  "Boston Scientific's lead splitters give pain management physicians more choices to help optimize pain relief when using the Precision Plus System."  

"Our goal is to design products that provide lasting pain relief for patients," said Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division.  "We are pleased to introduce this expanded line of splitters for multi-site SCS lead placement."  

Pain is the most common reason Americans seek medical treatment, and an estimated 26 million Americans experience frequent back pain.  Many chronic pain patients have found that SCS helps them manage their pain and live better lives.  

Boston Scientific will present its full line of Neuromodulation products at booth #22/43 at the ASIPP annual meeting.

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.  For more information on Precision Plus technology, visit http://www.ControlYourPain.com.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.

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.

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