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Boston Scientific anuncia el marcado CE y primeros implantes para los electrodos de estimulación cardiacarm INGEVITY(TM)

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.[1]

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.

[1] 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.

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