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Contego Medical recibe la Marca CE para un stent de carótida de próxima generación
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News provided by

Contego Medical, Inc.

Apr 17, 2021, 12:26 ET

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RALEIGH, N.C., 17 de abril de 2021 /PRNewswire/ -- Contego Medical, Inc., un desarrollador líder de dispositivos cardiovasculares innovadores, ha dado a conocer hoy la recepción de la aprobación de la Marca CE para el stent de carótida de tipo 3 en 1 Neuroguard IEP® y el sistema de balón de post-dilatación con protección embólica integrada (sistema IEP Neuroguard).

El sistema IEP patentado Neuroguard cuenta con el nuevo stent de nitinol de última generación, un balón de posdilatación posicionado anteriormente, además de un filtro microembólico integrado que cuenta con poros de 40 μm. El stent de células cerradas se ha diseñado para conseguir un rendimiento óptimo en la fuerza radial, la cobertura de los vasos y la flexibilidad, y dispone también de un diseño de reloj de arena asimétrico único que se ensancha en ambos extremos para facilitar la aposición de la pared en una anatomía tortuosa. El filtro integrado se ha diseñado con el fin de capturar macro émbolos y micro émbolos durante todo el procedimiento. El sistema IEP Neuroguard sirve para llevar a cabo el tratamiento de pacientes adultos con estenosis de la arteria carótida clínicamente significativa que necesitan de un stent.

El sistema IEP Neuroguard se evaluó por primera durante la realización del ensayo clínico PERFORMANCE I. El estudio se llevó a cabo en nueve centros europeos, incluyendo a 67 pacientes durante un año de seguimiento. La tasa de éxito general fue del 100%, mostrando un accidente cerebrovascular y una tasa de muerte del 0% a los 30 días1.

"La Marca CE del sistema Neuroguard IEP es un hito destacado de cara a Contego Medical, y al mismo tiempo nos permite disponer de destacados beneficios de seguridad y rendimiento del stent Neuroguard para los pacientes en Europa", explicó Ravish Sachar, M.D., consejero delegado y fundador de Contego Medical. "Hemos previsto el lanzamiento del producto en países seleccionados, además de poner en marcha el inicio de un estudio clínico posterior a la comercialización en los próximos meses".

Stacy Enxing Seng, Venture Partner, Lightstone Ventures, y el presidente del consejo de administración médico de Contego, comentaron: "La recepción de la aprobación de la Marca CE para el sistema IEP Neuroguard supone un hito significativo para el equipo de Contego Medical, y representa una inversión de varios años en lo que respecta al desarrollo de productos innovadores y de investigación clínica de calidad. Considero que el sistema IEP Neuroguard presenta el rendimiento y la facilidad de uso de cara a pasar a ser el estándar de atención en lo que respecta al tratamiento de la enfermedad de las arterias carótidas".

Acerca de Contego Medical
Contego Medical, Inc. es una empresa de dispositivos médicos dedicada al desarrollo de instrumental médico innovador para su uso en procedimientos cardiovasculares y vasculares periféricos. La plataforma de protección antiembólica integrada (Integrated Embolic Protection o IEP) de la empresa, que combina protección antiembólica y tratamiento en un único dispositivo, está diseñada para simplificar los procedimientos con catéter y mejorar los resultados en pacientes.

En Estados Unidos, el Neuroguard IEP System es un dispositivo investigacional, estando limitado por la ley de Estados Unidos para un uso investigacional.

Neuroguard IEP y el logo de Contego Medical son marcas registradas de Contego Medical, Inc. Neuroguard System está cubierto por las patentes de Estados Unidos 9,968,472 y 10,932,929 y la patente europea EP 3,367,967. Están pendientes patentes adicionales en Estados Unidos y a nivel extranjero.

1 LINC 2020

SOURCE Contego Medical, Inc.

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