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Lanzamiento global del globo liberador de fármaco aprobado por la CE Protégé de Blue Medical y el stent de globo libertador de fármaco Pioneer


News provided by

Blue Medical

Mar 20, 2012, 05:00 ET

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HELMOND, Países Bajos, March 20, 2012 /PRNewswire/ --

Blue Medical ha anunciado hoy el lanzamiento de producto global de su globo liberador de fármaco aprobado por la CE (DEB) Protégé así como su stent CoCr en DEB Pioneer. El lanzamiento de mercado completo de la nueva tecnología DEB es un gran paso hacia la búsqueda de Blue Medical de mejorar la calidad de vida de los pacientes con enfermedades cardiovasculares, mientras se reducen los costes del procedimiento.

La nueva terapia DEB de Blue Medical ofrece una dosis controlada de Paclitaxel a la arteria coronaria durante la angioplastia de globo. El dispositivo combinado con un stent coronario CoCr ofrece fármacos durante la colocación del stent como una dosis una sola vez, en lugar del suministro de fármaco continuo conocido de los stents liberadores de fármacos. Esto reduce significativamente el período en que la medicación antiplaquetaria podría requerirse. Los bajos índices MACE y la baja pérdida de lumen tardía indican que la eficacia y seguridad de los productos Protégé y Pioneer DEB se confirman por los datos clínicos del Human Trial PIONEER de Blue Medical.

"El mayor riesgo de trombosis de stent tardía y la medicación antiplaquetaria doble a largo plazo que se asocia con la mayoría de los actuales stents liberadores de fármacos es una preocupación a la hora de tratar a los pacientes actualmente", dijo el principal investigador del estudio PIONEER, Peter Smits, M.D., responsable de Intervention Cardiology en el Maasstad Hospital, Rotterdam, Países Bajos. "La terapia DEB en combinación con stents coronarios de metal desnudo ofrece una solución potencial para reducir la pérdida de lumen tardía sin necesidad de una medicación antiplaquetaria doble a largo plazo, mejorando la comodidad del paciente y reduciendo riesgos de sangrado y trombosis de stent".

"Nuestro extenso esfuerzo de investigación combinado con la evaluación humana asegura una ciencia altamente escalable y una tecnología DEB efectiva", dijo Ronald Horvers, consejero delegado de Blue Medical. "La revisión crítica y extensiva del Comité de evaluación médico holandés y organismo notificado BSI nos permite ofrecer una alternativa atractiva para tratar la enfermedad coronaria".

Blue Medical continúa desarrollando sus nuevas tecnologías DEB en aplicaciones adicionales para la aplicación coronaria y periférica mediante sus programas científicos y clínicos.

Acerca de Blue Medical

Localizada en el área holandesa de Brainport, Blue Medical (http://www.bluemedical.com) es una compañía de dispositivos médicos global y una innovadora en el tratamiento de enfermedades cardiovasculares y periféricas. La compañía desarrolla, fabrica y comercializa productos médicos innovadores para enfermedades vasculares. Cada año, más de 100.000 pacientes son tratados con dispositivos de Blue Medical en países de todo el mundo.

SOURCE Blue Medical

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