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Datos de 12 meses de SELUTION SLR™ de MedAlliance presentados como prueba de última hora en LINC
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Jan 28, 2021, 14:22 ET

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- Datos de 12 meses por debajo de la rodilla con SELUTION SLR™ de MedAlliance presentados como prueba de última hora en LINC

NYON, Suiza, 28 de enero de 2021 /PRNewswire/ -- Los resultados de 12 meses del estudio PRESTIGE* Below-the-Knee (BTK) se han presentado como un ensayo de última hora en LINC 2021. El objetivo de esta investigación clínica ha sido evaluar los resultados de seguridad y rendimiento de SELUTION SLR™, el nuevo balón de elución de sirolimus de MedAlliance, para el tratamiento de lesiones oclusivas tibiales largas (TASC C & D) en pacientes con isquemia de extremidades crítica (CLI).

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12-Month Below-the-Knee Data with MedAlliance's SELUTION SLR™ Presented as Late Breaking Trial at LINC
12-Month Below-the-Knee Data with MedAlliance's SELUTION SLR™ Presented as Late Breaking Trial at LINC

La tasa de permeabilidad primaria fue del 78% y la tasa de cicatrización de heridas fue del 81%. La revascularización de la lesión objetivo (TLR) fue exhibida por el 93% de los pacientes y el 84% demostró supervivencia libre de amputación (AFS). Todas estas cifras se han mantenido a partir de los datos de seis meses.

PRESTIGE es un estudio clínico prospectivo, de un solo centro iniciado por un médico, dirigido en el Singapore General Hospital (SGH) por el Profesor Asociado Tze Tec Chong y el Dr. Tjun Yip Tang, ambos Consultores Senior en el Departamento de Cirugía Vascular del Hospital. Veinticinco pacientes fueron inscritos con una edad promedio de 64 años. El 88% tenía diabetes mellitus y el 44% tenía insuficiencia renal terminal. Ningún paciente requirió un stent de rescate. El seguimiento clínico fue a uno, tres, seis y 12 meses.

"Hemos observado fenómenos mínimos de flujo lento y algunos casos de cicatrización rápida de heridas con este balón. También es fácil de rastrear y entregar. Estamos deseando adquirir más experiencia clínica con este dispositivo" comentó el Prof. Chong.

CLI es una obstrucción grave de las arterias que reduce notablemente el flujo sanguíneo a las extremidades. Puede progresar hasta el punto de dolor intenso y úlceras o llagas en la piel: CLI a menudo conduce a la amputación.

Singapur tiene un alto porcentaje de diabéticos en su población y, por lo tanto, la CLI constituye un desafío importante entre los pacientes que se observan con la enfermedad arterial periférica (PAD). SGH realiza más de 1.000 procedimientos intervencionistas al año en pacientes que sufren de CLI.

"Estamos muy satisfechos con los resultados de BTK de un año en esta población de pacientes muy difícil", añadió el presidente y consejero delegado de MedAlliance Jeffrey B. Jump. "Esto complementa los excelentes resultados que hemos visto en SFA y pacientes coronarios".

En febrero de 2020 MedAlliance recibió la aprobación de marca CE para SELUTION SLR en el tratamiento de la enfermedad arterial periférica. Tanto el estudio STEP Pedal Arch como SUCCESS PTA, un gran estudio clínico posterior a la comercialización en PAD, comenzarán pronto a inscribirse. En Estados Unidos, SELUTION SLR ha recibido el estatus de designación de dispositivo innovador de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) para un DEB en el tratamiento de lesiones periféricas por debajo de la rodilla.

La tecnología de SELUTION SLR implica MicroReservoirs únicos hechos de polímero biodegradable mezclados con el fármaco anti-restenótico sirolimus. Estos MicroReservoirs proporcionan liberación controlada y sostenida del fármaco. La liberación prolongada de sirolimus de stents ha demostrado ser altamente eficaz tanto en vasculaturas coronarias como periféricas. La tecnología patentada CAT™ (Cell Adherent Technology) de MedAlliance permite recubrir los MicroReservoirs en balones y adherirse al lumen del vaso cuando se entregan a través de un balón de angioplastia.

* P hysician initiated, prospective, non-Randomized single-center trial, investigating the safety and Efficacy of the Treatment with the Selution Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients with critical limb Ischemia from SinGaporE.

Contacto de Medios: 

Richard Kenyon
[email protected]
+44 7831 569940

Fundada en 2008, MedAlliance es una empresa de tecnología médica de propiedad privada. Tiene su sede en Suiza, con instalaciones en Irvine, California; Glasgow, Reino Unido; y Singapur. MedAlliance se especializa en el desarrollo de tecnología innovadora y la comercialización de productos avanzados de combinación de dispositivos farmacológicos para el tratamiento de enfermedades arteriales coronarias y periféricas. Para más información visite: www.medalliance.com.

Foto - https://mma.prnewswire.com/media/1428937/MedAlliance_SELUTION_SLR.jpg  
Logo - https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

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https://medalliance.com

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