Boston Scientific Announces CE Mark for the Vercise™ Primary Cell Deep Brain Stimulation System
System includes first directional lead with current steering and expanded programming flexibility
Boston Scientific (NYSE: BSX) has received CE Mark for the Vercise™ Primary Cell (PC) Deep Brain Stimulation (DBS) System. The Vercise PC System is intended to provide precise neural targeting to address the varying needs of patients suffering from Parkinson's disease (PD), primary and secondary dystonia, and essential tremor. The System is a non-rechargeable treatment option that also powers the Vercise DBS Directional Lead, the first commercially available eight-contact segmented lead with current steering.
The Vercise platform is the only DBS solution that finely controls the size and shape of stimulation with multiple independent current control technology (MICC). The new Directional Lead with MICC produces multi-directional stimulation which increases target efficiency. The system includes unique software solutions with a Clinical Effects Map (CEM) that captures data over time, visually summarizes the progress of individualized patient therapy, and enables physicians to monitor and modify treatment as needed. These novel features allow for programming flexibility, designed to enable better outcomes with fewer side effects.
"Managing the side effects of unwanted stimulation while delivering effective therapy is one of the biggest challenges of DBS," said Prof. Dr. Jens Volkmann, director and chairman of the Department of Neurology, University Hospital of Würzburg. "The distinctive software solution of the new Vercise platform is straightforward yet intuitive and can help address this challenge."
DBS therapy involves the placement of a device that stimulates specific areas in the brain using electrical signals. The Vercise PC System supplements the company's rechargeable DBS device, a system with an unparalleled 25-year battery life.
"The dual portfolio offering of a non-rechargeable system with current steering as well as a rechargeable system provides physicians and patients the ability to choose a platform that suits their needs while benefiting from the most advanced stimulation technology," said Prof. Dr. Volker Coenen, medical director of Stereotactic and Functional Neurosurgery, University Medical Center Freiburg.
The portfolio is supported by a robust clinical program including the ongoing INTREPID clinical trial in the United States and the VANTAGE Study in Europe. The VANTAGE Study demonstrated a highly significant and consistent improvement in motor scores as well as an increase in quality of life; the results were published in The Lancet Neurology last quarter.
"This new system exemplifies the Boston Scientific commitment to advancing DBS therapy and providing impactful and transformative technology to reach a broader range of patients suffering from these debilitating diseases," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "Our clinical evidence, unique software solution, and expanded portfolio, now with both rechargeable and non-rechargeable devices, enable physicians to provide their patients with a tailored solution."
The Vercise PC DBS System is not available for use or sale in the United States. The rechargeable Vercise DBS System is investigational in the U.S., currently being evaluated in the INTREPID Study.
Comparative statements true as of September 10, 2015.
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 35 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 our business plans, product approvals, clinical trials and impact of data, 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.