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Boston Scientific Receives CE Mark Approval For GUIDE™ DBS System
NATICK, Mass., May 27, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of the GUIDE DBS System, the world’s first deep brain stimulation (DBS) visualization system. GUIDE DBS provides clinicians with 3D visualization information that simulates stimulation output, which may reduce programming time and enable more precise targeting of therapy. With GUIDE DBS, physicians are able to visualize the relative position of lead location and utilize stimulation field models within the brain.
“GUIDE DBS is an important tool for advancing DBS,” said Prof. Dr. Jens Volkmann, director of the Department of Neurology at the University Clinic Wurzburg in Germany. “The visualization of the stimulation fields is designed to improve therapy because physicians may take advantage of the unique programming options of the Vercise DBS System.”
The innovative GUIDE DBS technology, combined with the Vercise DBS System, was developed to provide the most advanced deep brain stimulation technology to neurologists, neurosurgeons and their patients. By visualizing the advanced stimulation options of the Vercise DBS System, clinicians can provide more tailored stimulation therapy to help meet patient needs.
GUIDE DBS is based on more than a decade of research and science validated in more than 30 peer-reviewed publications. It is the first commercial product resulting from the Boston Scientific acquisition of Intelect Medical in 2011.
“GUIDE DBS is a groundbreaking technology,” said Maulik Nanavaty, president of the Boston Scientific Neuromodulation division. “This innovative system is the first of its kind and designed to help physicians provide better therapy for their patients and improve programming time.”
GUIDE DBS and the Vercise DBS System are CE Marked for the treatment of Parkinson’s disease. The Vercise DBS System was approved for sale in Europe in 2012.
Parkinson’s disease is a progressive neurological disorder which affects 6.3 million people worldwide, according to the European Parkinson’s Disease Association.
In the U.S., the GUIDE DBS and Vercise DBS Systems are investigational and not available for sale.
Boston Scientific is an innovation leader in implantable DBS technology. The Vercise DBS System is the first and only DBS system commercially available to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology designed to provide physicians a fine level control of stimulation. Through its investments in technology, clinical science, and world-class service, Boston Scientific is committed to Making life smoother for physicians and patients.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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 our business plans, markets for our products, regulatory approvals, our technology and its importance, 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.
CONTACT:
Peter Lucht
508-650-8796 (office)
Global Media Relations
Boston Scientific Corporation
media@bsci.com
Ryan Davenport
763-494-2664 (office)
Global Media Relations
Boston Scientific Corporation
media@bsci.com
Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
SOURCE Boston Scientific Corporation
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