Welcome!

News Feed Item

First Patient Enrolled In Clinical Registry Assessing Boston Scientific Vercise™ Deep Brain Stimulation System In Patients With Parkinson's Disease

Study to Evaluate Clinical Outcomes and Economic Value of the Vercise™ Deep Brain Stimulation (DBS) System

NATICK, Mass., April 10, 2014 /PRNewswire/ -- 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.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 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.

1.     http://www.epda.eu.com/en/parkinsons/in-depth/parkinsonsdisease/

CONTACTS:  
Media: Ryan Davenport 
612-240-0492 (cell) 
Global Media Relations 
Boston Scientific Corporation 
[email protected] 

Investors: Susie Lisa, CFA 
508-652-5345 (office) 
Investor Relations 
Boston Scientific Corporation 
[email protected]

SOURCE Boston Scientific Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
SYS-CON Events announced today that Datera, that offers a radically new data management architecture, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera is transforming the traditional datacenter model through modern cloud simplicity. The technology industry is at another major inflection point. The rise of mobile, the Internet of Things, data storage and Big...
Kubernetes is an open source system for automating deployment, scaling, and management of containerized applications. Kubernetes was originally built by Google, leveraging years of experience with managing container workloads, and is now a Cloud Native Compute Foundation (CNCF) project. Kubernetes has been widely adopted by the community, supported on all major public and private cloud providers, and is gaining rapid adoption in enterprises. However, Kubernetes may seem intimidating and complex ...
SYS-CON Events announced today that Calligo, an innovative cloud service provider offering mid-sized companies the highest levels of data privacy and security, has been named "Bronze Sponsor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Calligo offers unparalleled application performance guarantees, commercial flexibility and a personalised support service from its globally located cloud plat...
"We focus on SAP workloads because they are among the most powerful but somewhat challenging workloads out there to take into public cloud," explained Swen Conrad, CEO of Ocean9, Inc., in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"Outscale was founded in 2010, is based in France, is a strategic partner to Dassault Systémes and has done quite a bit of work with divisions of Dassault," explained Jackie Funk, Digital Marketing exec at Outscale, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are still a relatively small software house and we are focusing on certain industries like FinTech, med tech, energy and utilities. We help our customers with their digital transformation," noted Piotr Stawinski, Founder and CEO of EARP Integration, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"I think DevOps is now a rambunctious teenager – it’s starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We've been engaging with a lot of customers including Panasonic, we've been involved with Cisco and now we're working with the U.S. government - the Department of Homeland Security," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
"We're here to tell the world about our cloud-scale infrastructure that we have at Juniper combined with the world-class security that we put into the cloud," explained Lisa Guess, VP of Systems Engineering at Juniper Networks, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, provided a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services with...
"We want to show that our solution is far less expensive with a much better total cost of ownership so we announced several key features. One is called geo-distributed erasure coding, another is support for KVM and we introduced a new capability called Multi-Part," explained Tim Desai, Senior Product Marketing Manager at Hitachi Data Systems, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"I'm here to leverage my secret sauce, which is using outsourced development and the company that I utilize is delaPlex Software and they've basically allowed me to win Fortune 500 companies," noted Justin Witz, CTO of FRA and PlanTools, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.