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SINOMED® completa el seguimiento de un año del ensayo PIONEER-III
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SINOMED logo (PRNewsfoto/SINOMED)

News provided by

Sino Medical Sciences Technology Inc. (SINOMED)

Jul 13, 2020, 03:00 ET

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- SINOMED® completa el seguimiento de un año del ensayo europeo, estadounidense y japonés PIONEER-III del stent liberador de fármaco coronario BuMA Supreme®

TIANJIN, China, 13 de julio de 2020 /PRNewswire/ -- SINOMED, un desarrollador de tecnologías neuro- y cardiovasculares innovadoras, anunció la finalización del seguimiento de un año del ensayo global aleatorio PIONEER-III, que evalúa el BuMA Supreme Drug-Eluting Coronary Stent (DES). Una vez completado, la compañía planea entregar los datos a la Administración de Alimentos y Fármacos de EE. UU. y a la Agencia Japonesa de Medicamentos y Dispositivos Médicos para la aprobación del dispositivo. 

"A pesar de los problemas de gestionar la pandemia del COVID, todos los implicados en el estudio han realizado un tremendo esfuerzo por terminar el seguimiento clínico necesario", dijo Martin B. Leon, MD, Columbia University Medical Center, EE.UU., y presidente del Comité Ejecutivo del estudio PIONEER-III. "Con la finalización del seguimiento, podemos centrarnos ahora en analizar los datos y planificar la presentación y publicación de los hallazgos en la segunda mitad de 2020. La finalización de este estudio podría ayudar a dirigir SINOMED para convertirse en la primera compañía china en obtener la aprobación de la FDA para un stent liberador de fármaco."

El ensayo PIONEER-III completó el seguimiento de 1.631 pacientes en 74 sitios en Norteamérica, Europa y Japón. Los pacientes que presentaron una enfermedad coronaria sintomática fueron seleccionados aleatoriamente 2:1 para recibir el BuMA Supreme DES o cualquier stent liberador de everolimus de polímero duradero.  La conclusión del ensayo clínico es un fallo de lesión objetiva (TLF) a los 12 meses y los pacientes serán seguidos durante cinco años después del estudio. Además, el ensayo está promovido por un análisis de referencia a largo plazo de TLF entre uno y cinco años, que busca la superioridad de BuMA DES sobre el brazo de control.

BuMA Supreme es una nueva evolución de DES, desarrollado para maximizar la curación funcional de los vasos sanguíneos después de una implantación de stent. Su diseño innovador utiliza una combinación de una nueva tecnología de recubrimiento cinético y patentado de liberación de fármacos para permitir un retorno más rápido de la funcionalidad celular natural, en comparación con otros DES disponibles comercialmente. Esta restauración saludable se cree que contribuye a mejores resultados clínicos a largo plazo.

BuMA Supreme con una nueva plataforma de cromo de cobalto y sistema de entrega está aprobado por la CE y está disponible para distribución en determinadas regiones. BuMA Supreme es un dispositivo de investigación en Estados Unidos y Japón.  

Acerca de SINOMED

Sino Medical Science Technology Inc. (SINOMED) es una compañía mundial dedicada a los dispositivos médicos que promueve el desarrollo, investigación, producción y distribución a nivel comercial de dispositivos de intervención. Nos centramos en el desarrollo de tecnologías novedosas para dirigirnos a hacer frente con las necesidades clínicas no cumplidas dedicadas al tratamiento intervencional de la enfermedad cardiaca estructural, coronaria y neurovascular.

Para más información, visite: www.sinomed.com

Logo: https://mma.prnewswire.com/media/950402/Sinomed_Logo.jpg

Contacto:
SINOMED B.V
Cindy Zheng
Wilhelminakade 173
3072AP Rotterdam
Países Bajos
T:  +31-10-307-6295
E: [email protected] 

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