Boston Scientific Corporation (NYSE: BSX) today announced one-year data from the INTREPID study, the first and only prospective, double-blind, randomized, sham-controlled, multi-center study of deep brain stimulation (DBS) for advanced, levodopa-responsive Parkinson’s disease (PD) in the United States.
MARLBOROUGH, Mass., April 24, 2018 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced one-year data from the INTREPID study, the first and only prospective, double-blind, randomized, sham-controlled, multi-center study of deep brain stimulation (DBS) for advanced, levodopa-responsive Parkinson’s disease (PD) in the United States. The study is a late-breaking emerging science session presentation at today’s meeting of the 70th Annual American Academy of Neurology Meeting in Los Angeles.
The INTREPID study evaluated 292 patients at 23 sites in the U.S. and successfully met its primary and secondary endpoints. The data, which supported the recent U.S. FDA approval of the VERCISETM DBS System for the control of symptoms of PD, demonstrated the safety and effectiveness of one of the most innovative additions to the field of DBS in 30 years. DBS is used to treat the symptoms of PD, a degenerative condition that affects more than one million people in the U.S. and 10 million worldwide.1
Highlights of the one-year results include:
- A 49.2 percent improvement in motor symptoms as measured by clinicians in Unified Parkinson’s Disease Rating Scale (UPDRS) III scores compared to pre-surgery screening;
- A six-hour improvement in on time without troublesome dyskinesias as measured by a patient-completed three-day PD diary (motor diary);
- More than 40 percent of stimulation programs used current that was fractionalized over two or more contacts; and
- An overall sustained improvement in quality of life as measured by the Parkinson’s Disease Questionnaire 39 (PDQ-39).
“This study meets a new level of rigor in evaluating the effectiveness of a DBS system,” said Jerrold Vitek, M.D., Ph.D, McKnight professor and chair, Department of Neurology, University of Minnesota Medical School and coordinating principal investigator for the INTREPID study. “The double-blind design gives us confidence that the improvements in patients on time with good symptom control, as evaluated by the diary data, are an objective measure of the outcomes and suggests patients will benefit from the Vercise System.”
DBS works by stimulating a targeted region of the brain through implanted leads that are powered by a device called an implantable pulse generator. The Vercise System is based on a foundation of cochlear implant technology and works by allowing the physician to independently control the amount of current delivered by each of the eight electrodes on the implanted leads; this proprietary technology is known as multiple independent current control. The Vercise System technology is designed to address patient needs and the progressive nature of the condition with a battery life, depending on individual use, of more than 15 years and stimulation that can be adapted as the condition progresses.
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.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 product launches and product performance and impact. 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; the closing and integration of acquisitions; 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.
CONTACTS
Media:
Catherine Brady
Media Relations
508-683-4797
Catherine.Brady@bsci.com
Investors:
Susie Lisa, CFA
508-683-5565 (office)
Investor Relations
Boston Scientific Corporation
BSXInvestorRelations@bsci.com
View original content with multimedia: http://www.prnewswire.com/news-releases/boston-scientific-announces-positive-late-breaking-data-from-the-intrepid-study-300634745.html
SOURCE Boston Scientific Corporation