NATICK, Mass., June 18, 2013 /PRNewswire/ -- Patients with Parkinson's disease using the Boston Scientific Corporation (NYSE: BSX) Vercise™ DBS (deep brain stimulation) System showed a significant improvement in motor scores according to interim data from the VANTAGE DBS study. Data from the six month follow-up of up to 40 participants enrolled in the VANTAGE trial were presented at the annual International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia by Prof. Dr. Lars Timmermann, of University Hospital in Koln, Germany.
The Vercise DBS System incorporates multiple independent current control, which is designed to selectively stimulate targeted areas in the brain, providing physicians with fine control of stimulation.
Preliminary analysis of the VANTAGE study displays approximately 60 percent mean improvement in motor function at six months post implant, as assessed by UPDRS III1 when compared to baseline. The Boston Scientific sponsored study was designed to document patient outcomes. These include effectiveness, safety, and health economic data derived from bilateral stimulation of the subthalamic nucleus (STN) in the brain using the implantable Vercise DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic Parkinson's disease. Forty participants with Parkinson's disease were implanted bilaterally at six European centers.
"We are pleased to see such a significant improvement in motor function," said Prof. Dr. Francois Alesch, professor for Stereotactic and Functional Neurosurgery at Medical University, Vienna, Austria and neurosurgical principal investigator of the trial. "I believe this unique technology, with its multiple current sources, may provide us with a more adaptable form of DBS therapy. I was very pleased with the simple recharging system. All of my patients were able to recharge successfully."
Highlights of the VANTAGE study interim data include:
- All 40 participants underwent successful implantation of the Vercise DBS System.
- The Vercise DBS System demonstrated a significant improvement in motor function (p<0.0001), as assessed by UPDRS III1 (approximately 60 percent mean improvement) at six (6) months post first lead implant as compared with baseline.
- Preliminary analysis suggests the Vercise DBS System improved participants' ON time, as assessed by at-home motor diaries, activities of daily living2 and quality of life3 at six months.
- The charging of the Vercise DBS System was well tolerated by all participants.
"With these data, clinicians can be confident in their decision to implant the Vercise DBS System," said Prof. Dr. Lars Timmermann, neurological principal investigator of the trial. "The ability to utilize multiple independent current control to selectively stimulate areas within the brain may provide improved outcomes for these patients. I look forward to seeing the longer term data from the VANTAGE study."
"The VANTAGE study is a key facet of our DBS program and emphasizes our commitment to advancing therapy through clinical research with the Vercise DBS System," said Maulik Nanavaty, president of the Boston Scientific Neuromodulation division. "The significance of the reduction in motor scores is a testament to the capabilities of the Vercise System. We continuously strive to develop innovative technologies that improve patient outcomes."
The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in Europe, Israel and Australia. In the U.S., the Vercise DBS System is investigational and not available for use or sale.
Parkinson's disease is a progressive neurodegenerative disorder that affects about one million Americans and seven to 10 million people worldwide, according to the World Health Organization and the Parkinson's Disease Foundation.
1 Unified Parkinson's Disease Rating Scale part III (UPDRS III) 2 Assessed with Unified Parkinson's Disease Rating Scale part II (UPDRS II) 3 Quality of life assessed with the Parkinson's Disease Questionnaire (PDQ-39)
Boston Scientific is an innovation leader in implantable DBS technology. 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. To view or download an image of the Vercise DBS System, please visit our newsroom image gallery.
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, 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 firstname.lastname@example.org
Michael Campbell 508-650-8023 (office) Investor Relations Boston Scientific Corporation email@example.com
SOURCE Boston Scientific Corporation