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CryoLife anuncia el primer implante europeo del injerto HeRO
Date:7/31/2013

resto del año formaremos a médicos adicionales en torno al procedimiento, lo que apoyará el lanzamiento a escala más amplia en Europa a comienzos del año 2014. Seguimos creyendo que el injerto HeRO representa una oportunidad destacada para proporcionar una mejor opción de acceso de diálisis a los pacientes con enfermedad renal en fase final y que será un impulsor de crecimiento para la compañía".

Acerca del injerto HeROEl injerto HeRO recibió el permiso inicial FDA 510(k) en 2008 y la aprobación inicial de la Marca CE en 2011. Está indicado para pacientes ESRD dependientes de catéter con hemodiálisis a largo plazo que han agotado otras opciones de acceso, como fístulas AV e injertos (AVFs y AVGs). Antes de la introducción del injerto HeRO, la única opción para estos pacientes era el acceso por medio de los catéteres de diálisis tunelados percutáneos (TDCs), que presentan un coste elevado, tienen altas tasas de infección, limitan el estilo de vida de los pacientes y fomentar la estenosis venosa central o estrechamiento. El injerto HeRO supera las limitaciones de TDCs al proporcionar un injerto subcutáneo completo que funciona como un injerto de acceso regular durante la diálisis, proporcionando un flujo de sangre superior y una reducción de un 69% de la bacteremia (bacterias en la sangre) frente a los TDCs. El injerto HeRO es la única solución de acceso AV subcutáneo demostrada clínicamente que mantiene el acceso a largo plazo para los pacientes con hemodiálisis y estenosis venosa central.

El injerto HeRO se ha implantado en más de 6.000 pacientes hasta la fecha, y tiene el apoyo de ceca de 130 presentaciones y estudios clínicos publicados. El producto ha conseguido unas tasas de reembolso en Estados Unidos, con unos códigos de reembolso respaldados por medio de la&
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SOURCE CryoLife, Inc.
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