|By PR Newswire||
|August 30, 2014 12:39 PM EDT||
MARLBOROUGH, Mass., Aug. 30, 2014 /PRNewswire/ -- Boston Scientific has released the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial, the first and only randomized sham-controlled clinical trial investigating vagus nerve stimulation (VNS) for the treatment of heart failure patients. Faiez Zannad, M.D., Ph.D., Professor of Therapeutics and Cardiology and Director of the Clinical Investigation Center at the Institut National de la Sante et de la Recherche Medicale presented the results at the 2014 European Society of Cardiology (ESC) Congress in Barcelona, Spain. The results will also be published in the European Heart Journal.
The study evaluated 96 New York Heart Association (NYHA) Class II-III patients with heart failure and an ejection fraction of less than 35%. All patients continued receiving optimal medical treatment for heart failure, but were randomized 2:1 to treatment or sham (implanted device but not receiving therapy), respectively.
The trial did not meet the pre-specified six month primary efficacy endpoint of a reduction in left ventricular end systolic diameter as assessed by a blinded echocardiography core laboratory. Quality of life metrics demonstrated significant symptomatic improvement despite the lack of a significant effect on primary and secondary endpoint measures of cardiac remodeling and functional capacity in HF patients.
"The careful design and execution of NECTAR-HF has resulted in high quality data that will improve the understanding of the role of VNS in the treatment of patients with heart failure," said Prof. Zannad, NECTAR-HF Principal Investigator. "Although patients receiving therapy reported feeling better as assessed by quality of life questionnaires, the application of VNS failed to reveal clear benefit when compared to sham, because the effect of therapy was no better than sham on echocardiography derived measurements. Inclusion of an appropriate control group is crucial, and a randomized study like NECTAR-HF should be the benchmark for future studies of novel device therapies for the treatment of heart failure."
After six months of randomization, control patients begin to receive active therapy. All patients are followed through 18 months for the safety endpoint.
"We are pleased to have collaborated with the investigators who have added significantly to the scientific knowledge of vagus nerve stimulation for the treatment of heart failure," said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management for Boston Scientific. "We remain committed to advancing clinical science, exploring novel therapies, and providing new diagnostic options for patients with heart failure."
* The implantable VNS system is not available for sale, and is for investigational use only.
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 new product launches and launch cadence, regulatory approvals, clinical trials, 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.
Global Media Relations
Boston Scientific Corporation
PR and Corporate Communication EMEA
Boston Scientific Corporation
+ 39 3387936422 (mobile)
+ 39 0106060281 (direct)
Susie Lisa, CFA
Boston Scientific Corporation
SOURCE Boston Scientific Corporation
Qosmos, the market leader for IP traffic classification and network intelligence technology, has announced that it will launch the Launch L7 Viewer at CloudExpo | @ThingsExpo Silicon Valley, being held November 1 – 3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The L7 Viewer is a traffic analysis tool that provides complete visibility of all network traffic that crosses a virtualized infrastructure, up to Layer 7. It facilitates and accelerates common IT tasks such as VM migra...
Oct. 27, 2016 01:30 AM EDT Reads: 408
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
Oct. 27, 2016 01:00 AM EDT Reads: 34,288
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Oct. 27, 2016 12:45 AM EDT Reads: 2,140
So you think you are a DevOps warrior, huh? Put your money (not really, it’s free) where your metrics are and prove it by taking The Ultimate DevOps Geek Quiz Challenge, sponsored by DevOps Summit. Battle through the set of tough questions created by industry thought leaders to earn your bragging rights and win some cool prizes.
Oct. 27, 2016 12:30 AM EDT Reads: 4,185
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 27, 2016 12:00 AM EDT Reads: 1,108
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Oct. 27, 2016 12:00 AM EDT Reads: 3,535
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
Oct. 27, 2016 12:00 AM EDT Reads: 11,125
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Oct. 26, 2016 11:30 PM EDT Reads: 9,747
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Oct. 26, 2016 11:00 PM EDT Reads: 3,917
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Oct. 26, 2016 11:00 PM EDT Reads: 9,906
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Oct. 26, 2016 11:00 PM EDT Reads: 639
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 26, 2016 09:45 PM EDT Reads: 1,132
SYS-CON Events announced today that CDS Global Cloud, an Infrastructure as a Service provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. CDS Global Cloud is an IaaS (Infrastructure as a Service) provider specializing in solutions for e-commerce, internet gaming, online education and other internet applications. With a growing number of data centers and network points around the world, ...
Oct. 26, 2016 09:45 PM EDT Reads: 3,663
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, will discuss how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team a...
Oct. 26, 2016 09:30 PM EDT Reads: 679
SYS-CON Events announced today that Transparent Cloud Computing (T-Cloud) Consortium will exhibit at the 19th International Cloud Expo®, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The Transparent Cloud Computing Consortium (T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data proces...
Oct. 26, 2016 08:15 PM EDT Reads: 1,475