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LimaCorporate anuncia la aprobación de la FDA para un estudio IDE sobre Smr Stemless Reverse Shoulder System
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Limacorporate S.p.A.

Nov 23, 2020, 06:14 ET

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UDINE, Italia, 19 de noviembre de 2020 /PRNewswire/ -- LimaCorporate se enorgullece al anunciar que la Administración de Alimentos y Fármacos de Estados Unidos (FDA) ha aprobado la exención de dispositivo investigacional (IDE) para comenzar el ensayo clínico sobre SMR Stemless Reverse Shoulder System.

La aprobación de la FDA permite a LimaCorporate comenzar un ensayo clínico comparativo multicentro aleatorio sobre SMR Stemless Reverse en Estados Unidos para evaluar la seguridad y eficacia en comparación con el SMR Reverse Shoulder System, con una artroplastia de hombro inversa total. El ensayo va a reclutar a 200 pacientes con un seguimiento de dos años, estando previsto que comience en el primer trimestre de 2021 y en el que estarán implicados siete sitios de investigación de Estados Unidos. SMR Stemless Reverse System ha recibido aprobación en Europa, México y mercados selectos APAC, incluyendo Australia, Nueva Zelanda y Corea del Sur.

El SMR Stemless Reverse, parte del SMR System, es un innovador implante de artroplastia de hombro de recambio de hueso indicado para el tratamiento de pacientes con un puño rotador deficiente, contando con la ventaja de preservar el hueso del húmero y consiguiendo unos procedimientos de revisión mejores, además de prevenir las complicaciones relacionadas con la raíz. Según un reciente informe de mercado publicado por Med Device Online el 11 de abril de 2018, el uso de implantes sin raíz en la artroplastia de hombro se espera que supere el uso de los implantes con raíz en Europa para el año 2025. Se ha indicado además que las previsiones futuras de mercado para Estados Unidos muestren una tendencia de crecimiento similar a la de los implantes sin raíz.  

El SMR Stemless Reverse Shoulder System es compatible con los componentes anteriores del SMR Reverse Shoulder con permiso de la FDA que están en el mercado desde 2011. Stemless Core dispone de Trabecular Titanium (TT), la tecnología de impresión 3D de LimaCorporate, además de un revestimiento inverso de la parte del húmero. Desde el punto de vista del glenoide, la glenoesfera de polietileno representa una solución innovadora en la artroplastia de hombro inversa debido a la inversión de los materiales, que evita el fenómeno de escalonado escapular, que se suele asociar con este tipo de cirugía.

Luigi Ferrari, consejero delegado de LimaCorporate, comentó: "Estamos muy emocionados acerca de la aprobación del estudio IDE de SMR Stemless Reverse. Se trata de un hito importante y estratégico para LimaCorporate, que nos permite comenzar con el ensayo clínico de un dispositivo que hace frente a las necesidades de artroplastia de hombro inversa en el mercado de Estados Unidos. El estudio IDE demuestra el objetivo de LimaCorporate para mejorar las vidas de los pacientes por medio del alcance e innovación constantes, empoderando y ayudando a los cirujanos a restaurar la emoción del movimiento en sus pacientes".

Michael Bauer, socio de EQT y co-director del equipo del sector de cuidado de la salud de EQT, añadió: "La aprobación IDE es un hito destacado a la vez que LimaCorporate sigue estando comprometido con el suministro a los cirujanos de soluciones innovadoras al tiempo que mantiene sus estándares más elevados para asegurar la seguridad al paciente y la eficacia de los implantes".

Acerca de LimaCorporate

LimaCorporate es una empresa de dispositivos médicos global que proporciona soluciones ortopédicas reconstructivas y a medida a los cirujanos que se enfrentan a los desafíos de mejorar la calidad de vida de sus pacientes. Con sede en Italia, LimaCorporate está comprometida con el desarrollo de productos y procedimientos innovadores que permiten a los cirujanos seleccionar la solución ideal para cada paciente individual. La gama de productos de LimaCorporate incluye revisión de articulaciones grandes e implantes primarios así como soluciones de extremidades completas que incluyen la fijación.

Si desea más información sobre la compañía visite la página web: limacorporate.com

Limacorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine - Italia
T: +39 0432 945511
E: [email protected]

Logo - https://mma.prnewswire.com/media/997351/LimaCorporate_Logo.jpg

SOURCE Limacorporate S.p.A.

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