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MiStent SES demuestra ser único en el entorno clínico
Date:10/28/2013

robación de la Marca CE (Conformite Europeenne) para MiStent SES para la Unión Económica Europea en junio de 2013, pero no ha sido aprobado en Estados Unidos ni en ningún otro país. En el año 2013 se completó un seguimiento de dos años de los estudios clínicos DESSOLVE I y II, y actualmente están bajo seguimiento a largo plazo.

Acerca de los estudios DESSOLVE I y DESSOLVE II

El ensayo DESSOLVE I, la primera evaluación clínica de seguridad y eficacia del producto investigacional MiStent SES®, trató a 30 pacientes con lesiones de novo en las arterias coronarias, abarcando un diámetro de entre 2,5 y 3,5 mm y dispuestos para el tratamiento con una longitud máxima de stent de 23 mm. Los sujetos fueron reclutados en cinco centros de estudio de Nueva Zelanda, Australia y Bélgica. Se evaluaron tres subgrupos de pacientes independientes de 10 pacientes cada uno usando angiografía, IVUS y OCT en tres puntos de tiempo: a los 4, 6 y 8 meses. El objetivo de eficacia primario fue la pérdida de lumen tardía en el stent. La seguridad se evaluó por la incidencia de MACE y la presencia de recubrimiento del puntal con el tejido dentro de la arteria tratada en cada punto de tiempo. William Wijns, M.D. y Ph.D. del Cardiovascular Center de Aalst, Bélgica, y John Ormiston, M.B.Ch.B. de la Mercy Angiography Unit, Auckland, Nueva Zelanda, son los investigadores co-principales de este ensayo.

El ensayo DESSOLVE II Marca CE (Conformite Europeenne) es un estudio aleatorio y multicentro de pacientes con angina de pecho estable documentada o inestable. El objetivo primario es la superioridad de MiStent SES en la minimización de la pérdida de lumen tardía en el stent a los nueve meses, frente a Endeavor® Sprint DES de Medtronic, tal y como se evaluó por
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SOURCE Micell Technologies
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