|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.
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