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Tercer permiso de la FDA para un revolucionario producto de Simbionix


News provided by

Simbionix USA Corporation

Mar 29, 2013, 03:26 ET

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CLEVELAND, March 29, 2013 /PRNewswire/ --

Simbionix USA Corporation, un líder mundial en productos de formación y educación de simulación médica, ha recibido el permiso de la FDA para su aplicación TEVAR (Thoracic Endovascular Aneurysm Repair) para PROcedure Rehearsal Studio™ (PRS). Esta aplicación se une a la gama de PRS con permiso para aplicaciones de marketing en intervenciones carótidas y procedimientos EVAR (Endovascular Aneurysm Repair) .

     (Logo: http://photos.prnewswire.com/prnh/20120502/529202-a )

TEVAR es una modalidad de tratamiento emergente que se ha integrado de forma rápida por los médicos que tratan la enfermedad torácica de la aorta. Es una aproximación mucho menos invasiva que una cirugía abierta. Además, la disponibilidad y relativa sencillez de aplicación de TEVAR han cambiado y ampliado las opciones de tratamiento en la enfermedad aórtica torácica, incluyendo la no viabilidad de los pacientes para una cirugía abierta. Las capacidades necesarias para realizar TEVAR requieren de una formación formal dedicada, ya que el procedimiento necesita de una demanda de percepción considerable, cognitiva y psicomotriz de cara a los cirujanos.

PROcedure Rehearsal Studio usa una tecnología revolucionaria desarrollada por Simbionix, que permite a los médicos ensayar un procedimiento endovascular completo en un modelo anatómico virtual 3D basado en los datos CT específicos de los pacientes. El modelo virtual podría usarse entonces para estimular, analizar y evaluar las opciones de tratamiento quirúrgicas pre-operativas antes de llevar a cabo el procedimiento actual, que podría aumentar la confianza de los médicos en el procedimiento venidero. Cuando el modelo 3D se haya exportado al entorno de estimulación Simbionix ANGIO Mentor™, los médicos podrán practicar varias veces la evaluación de las diferentes técnicas al tiempo que usan herramientas similares a las reales y endo-injertos.

La Society of Vascular Surgery sugiere que los cirujanos que realizan un mínimo de 100 diagnosis, 50 intervenciones y 10 casos TEVAR consigan el certificado. Con esta nueva e innovadora aplicación, los médicos podrán recibir finalmente formación completa sobre los procedimientos TEVAR, incluyendo el despliegue preciso de injertos de stent sencillos y múltiples, además del retoque de globos, antes de realizar operaciones de un paciente. PRS simplifica la planificación de procedimiento, además de proporcionar una solución completa para la formación y simulación de los procedimientos específicos de los pacientes destinados a mejorar el nivel profesional de los médicos expertos y novatos.

Según el doctor Yael Friedman, director de asuntos normativos de Simbionix, el registro de seguimiento de Simbionix en el suministro a los profesionales de la salud de innovadoras herramientas de simulación es la base de otro producto de éxito. "Thoracic Endovascular Aneurysm Repair es uno de los procedimientos médicos más avanzados que realizan los cirujanos endovasculares. Simbionix se complace en haber recibido el permiso de la FDA y se enorgullece de la nueva aplicación clínica TEVAR PROcedure Rehearsal Studio, que ayudará a los médicos a analizar y evaluar también las opciones de tratamiento quirúrgicas de tipo pre-operativas."

Simbionix USA Corporation es el proveedor líder en el mundo de productos para simulación y capacitación para profesionales médicos y el sector de la atención de la salud. La compañía se compromete con el despliegue de productos de alta calidad, avance del rendimiento clínico y optimización de los resultados de los procedimientos.

Visite: http://www.simbionix.com Facebook, Twitter y LinkedIn.

Contacto: Rebecca Levy, responsable de comunicaciones de marketing, [email protected], +1-216-2292040

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