|By PR Newswire||
|March 25, 2014 03:23 AM EDT||
NATICK, Massachusetts, March 25, 2014 /PRNewswire/ --
content="MSHTML 8.00.6001.19394">El primer implante se ha realizado en Francia, en las Nouvelles Cliniques Nantaises de Nantes.
Boston Scientific Corporation (NYSE: BSX) ha anunciado la aprobación del marcado CE y la comercialización en Europa de la familia de electrodos de estimulación cardíaca compatibles con la resonancia magnética (RM), INGEVITY™. Los electrodos de estimulación son cables aislados que conectan el marcapasos implantable con el corazón para el tratamiento de la bradicardia, una enfermedad por la que el corazón late con demasiada lentitud. Los marcapasos funcionan, en combinación con los electrodos, detectando el latido del corazón y estimulándolo.
La familia INGEVITY ofrece una amplia gama de electrodos que pueden colocarse mediante un kit introductor French 6, con modelos de fijación activo y pasivo. Los electrodos de estimulación para RM INGEVITY forman parte del sistema de marcapasos ImageReady™ MR, aptos para RM en determinadas condiciones, que incluye los generadores de impulsos VITALIO™ MRI, FORMIO™MRI, ADVANTIO™MRI e INGENIO™MRI.Cuando se utilizan con el sistema de control LATITUDE™ NXT, estos dispositivos permiten monitorizar a los pacientes de forma inalámbrica para detectar enfermedades como las arritmias auriculares.
El primer implante de un electrodo de estimulación INGEVITY para RM fue realizado el 3 de marzo por el Dr. Daniel Gras, de las Nouvelles Cliniques Nantaises de Nantes, Francia. «El electrodo INGEVITY para RM permite una manipulación y colocación excelentes en el interior del corazón», comentó el Dr. Gras. «Además, el sistema de estimulación Image Ready™ de Boston Scientific podría ser de utilidad para los pacientes que necesiten someterse a una resonancia magnética en algún momento de su vida».
«La plataforma de electrodos de estimulación INGEVITY para RM constitye un hito significativo en nuestra tecnología para la bradicardia y nuestra cartera de productos para el control del ritmo cardíaco», ha apuntado Michael Onuscheck, presidente y vicepresidente de Boston Scientific en Europa. «Estamos orgullosos de ofrecer una variedad de nuevos e innovadores electrodos para el control del ritmo cardíaco, diseñados para un rendimiento clínico superior a largo plazo: estos son los electrodos de estimulación INGEVITY para RM, los electrodos de desfibrilación RELIANCE 4-FRONT™ y la familia de electrodos ACUITY™ X4 para desfibriladores de terapia de resincronización cardíaca (CRT-D)».Uno de los primeros implantes del sistema AUTOGEN™ X4 para CRT-D que incorporaba estos tres tipos de electrodos ha sido llevado a cabo por el Dr. Gianluca Botto, Jefe de electrofisiología cardíaca y estimulación en el Hospital Sant'Anna en Como, Italia.
El subgrupo de datos del estudio INGEVITY para el apoyo de la aprobación del marcado CE muestra un rendimiento excelente, con valoraciones positivas en cuanto a la manipulación y la maniobrabilidad de los cables por un 99,5% de los médicos que realizaron los implantes.
La serie de ensayos INGEVITY incluye estudios clínicos multicéntricos, no aleatorizados y globales, como apoyo para la obtención de la aprobación del Marcado CE, de la FDA y de otras organizaciones reguladoras para la familia de electrodos INGEVITY. Más de 1.600 pacientes han recibido ya el implante en 78 centros repartidos en 16 países.
INGEVITY para RM, RELIANCE 4-FRONT, ACUITY X4, y AUTOGEN X4 CRT-D son dispostivos en fase de investigación no comercializados aún en EE.UU.
 INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study. Datos no publicados.
Sobre Boston Scientific
Boston Scientific transforma las vidas de las personas mediante soluciones médicas innovadoras que mejoran la salud de los pacientes en todo el mundo. Somos una empresa con más de 30 años de liderazgo internacional en el sector de la tecnología médica y contribuimos al avance del campo biocientífico, ofreciendo una amplia gama de soluciones de alto rendimiento, dirigidas a cubrir las necesidades de los pacientes y reducir los costes sanitarios. Para obtener más información, visite http://www.bostonscientific.com y síganos en Twitter y 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.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 23, 2016 05:15 AM EDT Reads: 1,830
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 23, 2016 04:45 AM EDT Reads: 4,270
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Oct. 23, 2016 03:45 AM EDT Reads: 1,686
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue an...
Oct. 23, 2016 03:30 AM EDT Reads: 2,949
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. 23, 2016 02:30 AM EDT Reads: 9,646
SYS-CON Events announced today that Streamlyzer 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. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
Oct. 23, 2016 02:30 AM EDT Reads: 941
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Oct. 23, 2016 02:30 AM EDT Reads: 846
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. 23, 2016 02:15 AM EDT Reads: 637
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. 23, 2016 02:00 AM EDT Reads: 10,959
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
Oct. 23, 2016 01:30 AM EDT Reads: 3,657
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...
Oct. 23, 2016 01:30 AM EDT Reads: 1,043
In the next forty months – just over three years – businesses will undergo extraordinary changes. The exponential growth of digitization and machine learning will see a step function change in how businesses create value, satisfy customers, and outperform their competition. In the next forty months companies will take the actions that will see them get to the next level of the game called Capitalism. Or they won’t – game over. The winners of today and tomorrow think differently, follow different...
Oct. 23, 2016 01:15 AM EDT Reads: 886
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Oct. 23, 2016 01:15 AM EDT Reads: 999
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 7-9, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
Oct. 23, 2016 12:45 AM EDT Reads: 3,544
The Internet of Things (IoT), in all its myriad manifestations, has great potential. Much of that potential comes from the evolving data management and analytic (DMA) technologies and processes that allow us to gain insight from all of the IoT data that can be generated and gathered. This potential may never be met as those data sets are tied to specific industry verticals and single markets, with no clear way to use IoT data and sensor analytics to fulfill the hype being given the IoT today.
Oct. 23, 2016 12:15 AM EDT Reads: 2,450
Donna Yasay, President of HomeGrid Forum, today discussed with a panel of technology peers how certification programs are at the forefront of interoperability, and the answer for vendors looking to keep up with today's growing industry for smart home innovation. "To ensure multi-vendor interoperability, accredited industry certification programs should be used for every product to provide credibility and quality assurance for retail and carrier based customers looking to add ever increasing num...
Oct. 23, 2016 12:00 AM EDT Reads: 451
The Open Connectivity Foundation (OCF), sponsor of the IoTivity open source project, and AllSeen Alliance, which provides the AllJoyn® open source IoT framework, today announced that the two organizations’ boards have approved a merger under the OCF name and bylaws. This merger will advance interoperability between connected devices from both groups, enabling the full operating potential of IoT and representing a significant step towards a connected ecosystem.
Oct. 23, 2016 12:00 AM EDT Reads: 1,194
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Oct. 23, 2016 12:00 AM EDT Reads: 1,826
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 22, 2016 11:45 PM EDT Reads: 723
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet a...
Oct. 22, 2016 11:45 PM EDT Reads: 4,466