Welcome!

News Feed Item

Boston Scientific Announces CE Mark Approval and First Implants of Ingevity[TM] MRI Pacing Leads

NATICK, Massachusetts, March 17, 2014 /PRNewswire/ --

 - First implant took place in France, at the Nouvelles Cliniques Nantaises in Nantes

Boston Scientific Corporation (NYSE: BSX) announces CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads. Pacing leads are insulated wires that connect an implantable pacemaker to the heart for treatment of bradycardia, a condition in which the heart beats too slowly.  Pacemakers work in conjunction with leads to sense and stimulate (or pace) the heart.  

The INGEVITY family offers a comprehensive set of leads that can be placed using a 6 French introducer, including passive and active fixation models.  INGEVITY MRI pacing leads are part of the ImageReady™ MR-conditional pacemaker system, which includes VITALIO™ MRI, FORMIO™MRI, ADVANTIO™MRI and INGENIO™MRI  pulse generators.  When used with the LATITUDE™ NXT patient management system, these devices wirelessly monitor patients for conditions such as atrial arrhythmias.  

The first implant of the INGEVITY MRI lead was performed on March 3rd by Daniel Gras, M.D., at the Nouvelles Cliniques Nantaises in Nantes, France.  "The INGEVITY MRI lead offers exceptional handling and placement within the heart," said Dr. Gras.  "In addition, the Boston Scientific ImageReady™ pacing system could help many patients who may require an MRI scan during their life."

"The INGEVITY MRI pacing leads platform represents a significant milestone in our bradycardia technology and CRM lead portfolio," said Michael Onuscheck, senior vice president and president, Boston Scientific Europe.  "We are proud to offer multiple, new and innovative CRM leads engineered for superior long-term clinical performance, including INGEVITY MRI pacing leads, RELIANCE 4-FRONT™ defibrillation leads, and the ACUITY™ X4 CRT family of leads."   One of the first implants of the AUTOGEN™ X4 CRT-D system incorporating all three of these new leads was performed by Dr Gianluca Botto, Head of Cardiac Electrophysiology and Pacing at Sant'Anna Hospital in Como, Italy.

The subset of data from the INGEVITY trial supporting CE mark approval demonstrates excellent performance including positive ratings on lead handling and maneuverability from 99.5% of implanters.[1]  

The INGEVITY trial series includes prospective, non-randomized, multi-center, global clinical studies to support the INGEVITY family of leads for CE Mark, FDA and other regulatory approvals. Over 1600 patients have been implanted at 78 centers in 16 countries.

INGEVITY MRI, RELIANCE 4-FRONT, ACUITY X4, and AUTOGEN X4 CRT-D are investigational devices and not available for sale in the U.S.

[1]INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study.  Data on file.

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 http://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, regulatory approvals, clinical and product performance and importance, 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.

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
As Cybric's Chief Technology Officer, Mike D. Kail is responsible for the strategic vision and technical direction of the platform. Prior to founding Cybric, Mike was Yahoo's CIO and SVP of Infrastructure, where he led the IT and Data Center functions for the company. He has more than 24 years of IT Operations experience with a focus on highly-scalable architectures.
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
An edge gateway is an essential piece of infrastructure for large scale cloud-based services. In his session at 17th Cloud Expo, Mikey Cohen, Manager, Edge Gateway at Netflix, detailed the purpose, benefits and use cases for an edge gateway to provide security, traffic management and cloud cross region resiliency. He discussed how a gateway can be used to enhance continuous deployment and help testing of new service versions and get service insights and more. Philosophical and architectural ap...
DXWorldEXPO LLC announced today that Telecom Reseller has been named "Media Sponsor" of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
By 2021, 500 million sensors are set to be deployed worldwide, nearly 40x as many as exist today. In order to scale fast and keep pace with industry growth, the team at Unacast turned to the public cloud to build the world's largest location data platform with optimal scalability, minimal DevOps, and maximum flexibility. Drawing from his experience with the Google Cloud Platform, VP of Engineering Andreas Heim will speak to the architecture of Unacast's platform and developer-focused processes.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
"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 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.
Chris Matthieu is the President & CEO of Computes, inc. He brings 30 years of experience in development and launches of disruptive technologies to create new market opportunities as well as enhance enterprise product portfolios with emerging technologies. His most recent venture was Octoblu, a cross-protocol Internet of Things (IoT) mesh network platform, acquired by Citrix. Prior to co-founding Octoblu, Chris was founder of Nodester, an open-source Node.JS PaaS which was acquired by AppFog and ...
The Founder of NostaLab and a member of the Google Health Advisory Board, John is a unique combination of strategic thinker, marketer and entrepreneur. His career was built on the "science of advertising" combining strategy, creativity and marketing for industry-leading results. Combined with his ability to communicate complicated scientific concepts in a way that consumers and scientists alike can appreciate, John is a sought-after speaker for conferences on the forefront of healthcare science,...
"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.
"The Striim platform is a full end-to-end streaming integration and analytics platform that is middleware that covers a lot of different use cases," explained Steve Wilkes, Founder and CTO at Striim, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...