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Boston Scientific Begins Patient Enrollment in Clinical Trial Assessing Deep Brain Stimulation for Parkinson's Disease

Tue, 11/09/2010 - 4:36am
Boston Scientific

NATICK, Mass., Nov. 9, 2010 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the first implantation of its Vercise™ Deep Brain Stimulation (DBS) System as part of the VANTAGE clinical trial.  VANTAGE is a multi-center, prospective trial designed to examine the improvement of motor function in approximately 40 European patients implanted with the Vercise DBS System for the treatment of Parkinson's disease.

The Vercise Deep Brain Stimulation System is a neurostimulation device designed to deliver electrical signals to specific areas within the brain through individual lead contacts that allow a more tailored amount of current flow based on patient needs.

The first patient was implanted by a team at University Hospital Koln in Germany led by Prof. Lars Timmermann, M.D., Professor of Neurology and Co-Principal Investigator of the trial, and Mohammad Maarouf, M.D., Vice-Chairman of the Department of Stereotaxy and Functional Neurosurgery.  

"DBS has been available for many years as a treatment for Parkinson's disease, but I believe this new technology could provide a major step forward in this area of therapy," said Prof. Timmermann.  "I look forward to the results of this study with great interest."

"We are excited to begin implanting patients with this innovative device, which represents a more advanced, focused and adaptable form of DBS therapy," said Prof. Francois Alesch, M.D., Professor for Stereotactic and Functional Neurosurgery, Medical University of Vienna, Austria and Co-Principal Investigator of the trial.

"The Vercise System is the only DBS system that incorporates multiple, independent current control designed to enable greater 'customization' of the therapy," said Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division.  "The Company is excited to expand into a new area of stimulation therapy, demonstrating our continued commitment to investment in neuromodulation technology to improve patients' lives."

The Vercise Deep Brain Stimulation System is not available for sale.

Parkinson's disease is a progressive neurodegenerative disorder that affects 2 million Europeans and 7 to 10 million people worldwide, according to the World Health Organization and the Parkinson's Disease Foundation.  

About Boston Scientific Neuromodulation

Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology.  The Precision Plus™ Spinal Cord Stimulator System 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 27A of the Securities Act of 1933 and 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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