Click here to close now.

SYS-CON MEDIA Authors: Dana Gardner, Elizabeth White, Jnan Dash, Kevin Jackson, Peter Silva

News Feed Item

Improved Device Programming Reduces Inappropriate Therapy and Risk of Death for Implantable Defibrillator Patients

MADIT-RIT Clinical Trial Study Results Published Today in the New England Journal of Medicine

NATICK, Mass., Nov. 6, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) and the University of Rochester Medical Center presented positive results from the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) clinical trial that demonstrated improved programming of  Boston Scientific dual-chamber implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death.  MADIT-RIT is a prospective randomized three-arm trial comparing conventional programming with two alternative settings: a high-rate therapy arm and a duration-delay arm.  The study was designed to determine if alternate programming could reduce the occurrence of inappropriate therapy in primary prevention patients.  The results were presented at the American Heart Association Scientific Sessions 2012 in Los Angeles.  The full MADIT-RIT results were published today in the New England Journal of Medicine

When compared to conventional programming, significant reduction of inappropriate therapy was seen in both the high-rate and duration-delay therapy arms [79 and 76 percent, respectively (p<0.001 in both arms)]. 

In the high-rate therapy arm, there was a significant 55 percent reduction of the risk of death (p=0.01) compared to conventional programming.  While not statistically significant, the risk of mortality was reduced in the duration-delay therapy arm by 44 percent (p=0.06). 

"MADIT-RIT shows that improved programming can dramatically reduce inappropriate therapies and increase survival when compared to conventional device programming," said Kenneth Stein, M.D., chief medical officer of the Cardiac Rhythm Management Group at Boston Scientific.  "This will have immediate clinical significance for physicians who implant and manage these devices.  While previous studies have shown that ICDs are very effective in preventing sudden cardiac death, this study demonstrates that substantially more lives can be saved and many unnecessary and inappropriate therapies can be avoided with improved device programming."

Both shock therapy and anti-tachycardia pacing (ATP) therapy were evaluated in the trial.  ICD and CRT-D devices constantly monitor the rate and rhythm of the heart and are designed to deliver electric shocks in response to very fast and potentially fatal heart rhythms.  Shocks are highly effective in returning the heart to a normal rhythm and provide life-saving therapy to patients who develop ventricular arrhythmias.  Anti-tachycardia pacing is effective in converting some types of fast heart rhythms.  The devices may be programmed to deliver ATP before the shock, and if successful, a shock can be avoided. 

The MADIT-RIT clinical trial was sponsored exclusively by Boston Scientific.  MADIT-RIT evaluated 1,500 primary prevention patients with an ICD or CRT-D at 98 centers in 15 countries, including the U.S., Europe, Canada, Israel and Japan.  The trial was conducted under the leadership of principal investigator Arthur J. Moss, M.D., professor of medicine at the University of Rochester Medical Center. 

"I have been the principal investigator of a series of MADIT trials that have improved survival of high-risk heart patients during the past 20 years," said Dr. Moss.  "I am pleased to report on our latest 1,500-patient MADIT study in which we have significantly improved the effectiveness of ICDs by reducing inappropriate electrical stimulation of the heart by up to nearly 80 percent while further increasing patient survival by up to 55 percent.  These life-saving findings from our current study add an important new chapter in the evolution of the ICD to improve the treatment of patients with advanced heart disease."

MADIT-RIT is an important continuation of Boston Scientific's exclusive sponsorship of landmark clinical trials.  More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this therapy by a clinical trial sponsored by Boston Scientific or its predecessor companies.  Boston Scientific estimates that 75,000 lives have been saved worldwide by implantable defibrillators over the past five years.

About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.  

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, markets for our products, clinical trials and the importance of their findings; clinical outcomes, 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.

CONTACT:

Steven Campanini


214-546-5034 (cell)


Media Relations


Boston Scientific Corporation


[email protected]




Michael Campbell


508-650-8023 (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 Media announced today that Blue Box as launched a popular blog feed on Cloud Computing Journal. Cloud Computing Journal aims to help open the eyes of Enterprise IT professionals to the economics and strategies that utility/cloud computing provides. Blue Box Cloud gives you unequaled agility, without the burden of designing, deploying and managing your own infrastructure. It’s the right choice when public cloud just won’t do. Blue Box Cloud is a managed Private Cloud as a Service (...
SOASTA, the leader in performance analytics, today reported record growth of the CloudTest community, exceeding 30,000 registered users of the CloudTest platform in Q1 2015. SOASTA also announced widespread adoption of its Web and mobile testing solutions, with more than 1,600 customers completing more than 285,000 tests using CloudTest during the quarter. This rapid growth shows that DevOps-driven digital businesses are embracing a more continuous approach to testing, and CloudTest is meeting t...
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will mee...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Compa...
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communication...
Chef and Canonical announced a partnership to integrate and distribute Chef with Ubuntu. Canonical is integrating the Chef automation platform with Canonical's Machine-As-A-Service (MAAS), enabling users to automate the provisioning, configuration and deployment of bare metal compute resources in the data center. Canonical is packaging Chef 12 server in upcoming distributions of its Ubuntu open source operating system and will provide commercial support for Chef within its user base.
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquir...
PubNub on Wednesday released an open source template to allow developers to add Skype-like video chat into their apps. The free template provides a fully functional video chat platform using WebRTC, PubNub and Google Authentication for a global, reliable collaboration solution. “While the WebRTC protocol has created huge excitement as a way to deliver video chat ubiquitously, there’s still a gap between the protocol itself and the ability to deploy a working, globally scaled, collaboration appl...
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
ProfitBricks has launched its new DevOps Central and REST API, along with support for three multi-cloud libraries and a Python SDK. This, combined with its already existing SOAP API and its new RESTful API, moves ProfitBricks into a position to better serve the DevOps community and provide the ability to automate cloud infrastructure in a multi-cloud world. Following this momentum, ProfitBricks has also introduced several libraries that enable developers to use their favorite language to code ...
SYS-CON Events announced today that Optimal Design, an Internet of Things solution provider, will exhibit at SYS-CON's Internet of @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Optimal Design is an award winning product development firm offering industrial design and engineering services to the consumer, medical, and defense markets.
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists will discuss how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations m...
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business applic...
SYS-CON Events announced today that Stratoscale, the new data center operating system, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Based in Herzeliya, Israel, Stratoscale is redefining the data center, developing a hardware-agnostic, software platform hyper-converging compute, storage and networking across the rack or data center. The self-optimizing platform automatically distributes all physical...