Boston Scientific Announces One-Year Results In The VANTAGE Clinical Study Evaluating The Vercise™ DBS System Data Presented at the 18th International Congress of Parkinson's Disease and Movement Disorders Demonstrate Highly Significant Improvement in Motor Function for Patients with Parkinson's Disease

NATICK, Mass., June 11, 2014 /PRNewswire/ -- Patients with Parkinson's disease (PD) treated with the Boston Scientific Corporation (NYSE: BSX) Vercise™ Deep Brain Stimulation (DBS) System demonstrated a highly significant and consistent improvement in motor scores, according to the latest one-year data. 

VANTAGE is a prospective, multi-center trial evaluating the Vercise DBS System assessing patient outcomes in PD, including effectiveness, safety and health economic data.  Forty patients with PD were treated with the Vercise DBS System at six European centers.

Results of the follow-up were presented at the 18th International Congress of Parkinson's Disease and Movement Disorders in Stockholm, Sweden by Prof. Dr. Lars Timmermann, of University Hospital in Koln, Germany.

The VANTAGE study reported a 62 percent improvement in motor function at 12 months post implant, as assessed by the UPDRS III1 scale, when compared to baseline.  This result is consistent with the six month interim data presented last year, demonstrating that patients benefitted from therapy over time.  In addition, patients reduced medication usage by 58 percent at 12 months compared to their usage prior to the DBS procedure.2 

"We are pleased to see not only a highly significant improvement in motor function over the longer term, but also a highly significant improvement in overall quality of life for the VANTAGE study patients3," said Prof. Dr. François Alesch, professor for Stereotactic and Functional Neurosurgery at Medical University, Vienna, Austria and neurosurgical principal investigator of the trial.  "I believe these results are rooted in the Vercise DBS System's multiple independent current control technology, which is designed for accurate neural targeting to improve patient outcomes and minimize the side effects of unwanted stimulation."

"We look forward to following these VANTAGE study patients over the next five years, especially since the Vercise DBS System is the only rechargeable DBS platform with a battery life of 25 years," said Prof. Dr. Lars Timmermann, neurological principal investigator of the trial. "With this system, patients will not need to undergo battery replacement surgery every few years and can expect to benefit from their therapy over time."

"We are pleased to see that the one-year VANTAGE study data deliver highly significant results, reinforcing our belief in the clear advantages of our Vercise DBS technology," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "We are committed to demonstrating the clinical value of our differentiated innovations with a cadence of clinical data releases including VANTAGE, the CUSTOM-DBS study, and the ongoing Vercise Registry."

DBS is a surgical treatment that can help reduce some PD symptoms.  It involves the placement of a device that stimulates specific areas of the brain using electrical signals.  DBS is typically used to treat people with advanced PD whose symptoms are no longer controlled by medication. PD is a progressive neurological disorder which affects 6.3 million people worldwide4

Boston Scientific is an innovation leader in implantable DBS technology.  The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in Europe, Israel, Australia and select countries in Latin America for PD, and has CE Mark approval for intractable primary and secondary dystonia. 

In the U.S., the Vercise DBS System is investigational and not available for use or sale.  The INTREPID clinical trial began enrollment in the U.S. in mid-2013 to evaluate the safety and effectiveness of the Vercise DBS System for the treatment of Parkinson's disease. 

  1. Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
  2. Calculated using levodopa equivalents
  3. Quality of life assessed with the Parkinson's Disease Questionnaire (PDQ-39) Schwab and England and motor diaries
  4. http://www.epda.eu.com/en/parkinsons/in-depth/parkinsonsdisease/

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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, clinical trials and data impact, product performance and impact, 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:
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
763-494-2664 (office)
media@bsci.com

Simonetta Balbi
PR and Corporate Communication EMEA
Boston Scientific Corporation
+ 39 3387936422 (mobile)
+ 39 0106060281 (direct)
Balbis@bsci.com

Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
508-652-5345 (office)
investor_relations@bsci.com

SOURCE Boston Scientific Corporation



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