First Patient Enrolled In Clinical Registry Assessing Boston Scientific Vercise Deep Brain Stimulation System In Patients With Parkinsons Disease
Study to Evaluate Clinical Outcomes and Economic Value of the Vercise™ Deep Brain Stimulation (DBS) System
Apr 10, 2014
Boston Scientific Corporation (NYSE: BSX) has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise™ Deep Brain Stimulation (DBS) System in patients with Parkinson's disease.
DBS is a surgical treatment option for patients with movement disorders such as Parkinson's disease (PD), whose symptoms are not adequately controlled with medication. PD is a progressive neurological disorder that affects 6.3 million people worldwide, according to the European Parkinson's Disease Association.1 The Vercise DBS System is an implantable medical device designed to selectively stimulate targeted areas in the brain, enabling customized therapy and helping improve the quality of life for PD patients.
The multi-center, prospective study is expected to enroll up to 300 patients with PD at leading hospitals internationally and will be led by co-principal investigators Prof. Dr. Gunther Deuschl, director of the Department of Neurology, University Hospital, Kiel, Germany, and Prof. Dr. Jan Vesper, Department of Functional Neurosurgery and Stereotaxy at Heinrich-Heine University Hospital in Dusseldorf, Germany.
"Parkinson's disease is a serious and progressive neurological disorder that affects millions of people worldwide. We welcome the opportunity to collect and review a more complete set of data to better understand the clinical impact and the potential of the Vercise DBS System to help manage symptoms of Parkinson's disease," said Prof. Dr. Vesper. "The unique features of the Vercise System, including the ability to selectively stimulate targeted areas of the brain via multiple independent current control, as well as the longevity of the Zero Volt™ battery, are designed for improved patient outcomes and enhanced clinical effectiveness."
The Vercise clinical registry is an example of the Boston Scientific commitment to advancing science through clinical research. A preliminary analysis of the VANTAGE study, a multi-center, prospective clinical trial for patients with PD implanted with the Vercise DBS System, demonstrated a mean improvement in motor function of 62.4 percent for patients at six months post implant, as assessed by the Unified Parkinson's Disease Rating Scale Part III, when compared to baseline.
"Boston Scientific is dedicated to supporting clinical research to bring forth innovative technologies that can help improve the quality of life for patients," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "This registry will enable us to provide physicians with a comprehensive, long term view of real world experience and results with the Vercise DBS System for the many patients affected by Parkinson's disease."
The Vercise DBS System received CE Mark and TGA (Australia Therapeutic Goods Administration) approval in 2012 and is available for sale in Europe, Israel, Australia and select countries in Latin America for the treatment of Parkinson's disease; the system also received CE Mark for the treatment of intractable primary and secondary dystonia in 2013. In the U.S., the Vercise DBS System is investigational and not available for use or sale.
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.eu 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 markets for our products, our business plans, 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.