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OMNIlife science, Inc. anuncia la aprobación dela PS Knee por la FDA


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OMNIlife science, Inc.

Jul 05, 2011, 16:03 ET

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EAST TAUNTON, Massachusetts, July 5, 2011 /PRNewswire/ --

OMNIlife science, Inc. (una filial de Orthopaedic Synergy, Inc.) anunció hoy la aprobación de su Apex PS Knee por parte de la Administración de Alimentos y Fármacos de Estados Unidos. La Apex Posterior Stabilized (PS) Knee es la última adición a la gama de productos de Apex Knee. El nuevo diseño se introdujo en el mercado europeo en la segunda mitad de 2010 y ha sido acogido positivamente por cirujanos y pacientes. Ahora se está introduciendo en el mercado estadounidense con un lanzamiento completo esperado para finales de 2011. El Apex PS Knee mantiene los elementos de diseño claves de la Apex Cruciate Retaining (CR) Knee, pero ofrece el sistema de poste y cámara preferido por los cirujanos que utilizan una sustitución de rodilla estabilizada posterior. El diseño innovador permite al Apex PS Knee tener hasta 30 grados adicionales de seguimiento ininterrumpido de la rótula en comparación con los diseños de rodilla estabilizada posterior competitivos, que requieren una mayor resección del hueso. El seguimiento de la rótula adicional reduce potencialmente el cambio de experimentar un problema que se ha asociado con las sustituciones de rodilla conocidas como el "sonido hueco" rotuliano. Un proceso escariador de un solo paso permite una transición intraoperativa integrada desde una CR Knee a una PS Knee según la preferencia del cirujano. Aprovechando la fosa intercondilar para la localización del corte "box" de Apex PS Knees, hay una reducción del 90% en el hueso eliminado en comparación con algunos diseños de PS Knee competitivos.

"Creemos que el diseño de la Apex PS Knee establecerá un nuevo estándar en la industria ortopédica que beneficiará a pacientes y cirujanos", explicó George Cipolletti, consejero delegado de OMNIlife science, Inc. y Orthopaedic Synergy, Inc.

"Realmente disfruto utilizando los instrumentos para la Apex PS knee; es realmente el protector más sencillo y repetible que he hecho nunca", afirmó Anthony F. Infante, Jr., D.O. "En el pasado, solía utilizar una inserción ultra congruente para la estabilización posterior por la cantidad de hueso eliminada en una PS Knee tradicional. Con el sistema OMNI, la cantidad de hueso adicional que se eliminó es tan importante que no tengo problemas para utilizar esta PS Knee en todos mis pacientes".

Acerca de OMNIlife science, Inc.

OMNIlife science, Inc. se fundó en 1999 como una organización dedicada al diseño, fabricación y distribución de dispositivos ortopédicos de alta calidad innovadores. La sede corporativa se localiza en East Taunton, Massachusetts. Los productos de OMNI están prescritos por cirujanos ortopédicos para sus pacientes que requieren una sustitución de la articulación total. Continuando el reto de diseño y funcionalidad de nuestros productos basados en avances persistentes en técnicas quirúrgicas reconstructoras, datos anatómicos y biomecánicos, así como entradas de cirujanos, la compañía está emergiendo como un líder en tecnología de vástago de cadera modular y sistemas de sustitución rotuliana. Información adicional en http://www.omnils.com.

Acerca de Orthopaedic Synergy, Inc.

Orthopaedic Synergy, Inc. funciona como una compañía holding para OMNIlife science, Inc., Enztec Limited y PRAXIM, SA. Juntas, estas compañías representan una preocupación ortopédica reconstructora global que se dedica al diseño, fabricación y distribución de dispositivos ortopédicos de alta calidad. Los objetivos de la compañía incluyen el crecimiento continuado mediante la adquisición estratégica de organizaciones con tecnología complementaria. El objetivo es adquirir empresas que mejoran el desarrollo de extensiones de línea a nuestras actuales ofertas de productos de la compañía así como innovadores productos que ofrecen opciones clínicas mejoradas para nuestros clientes. Información adicional en http://www.orthopedicsynergy.com.


 

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