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Nuevo tratamiento para la estenosis uretral, Optilume®, recibe aprobación CE
  • USA - English
  • Deutschland - Deutsch
  • France - Français


News provided by

Urotronic, Inc.

Sep 23, 2020, 08:07 ET

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El balón recubierto de medicamento de Urotronic proporciona una alternativa mínimamente invasiva y duradera para pacientes con estenosis en Europa

MINNEAPOLIS, 23 de septiembre de 2020 /PRNewswire/ -- Urotronic, Inc., una compañía de dispositivos médicos con sede en Minnesota anunció hoy que ha recibido la aprobación Conformité Européene (CE) Mark por su innovador catéter Optilume en Europa. Los pacientes europeos tendrán ahora acceso a esta innovadora tecnología.

Optilume combina la dilatación del balón de la estenosis uretral con la entrega de un fármaco antiproliferativo para evitar la recurrencia de la obstrucción. Los datos de seguimiento clínico de dos años1 publicados destacaron que Optilume funcionó según lo previsto tanto en la apertura de bloqueos como en la prevención de la formación de tejido cicatricial que puede desarrollarse rápidamente después de cualquier intervención médica. Se espera que la tecnología mínimamente invasiva tenga un impacto significativo en la comunidad de urología, ofreciendo una nueva opción de tratamiento para las estenosis uretrales que tradicionalmente requerirían cirugía mayor o necesitarían un retratamiento frecuente.

Se estima que más de un millón de hombres en toda Europa sufren de restricciones uretrales debilitantes2. La afección bloquea la vía para que la orina salga del cuerpo desde la vejiga y puede resultar en una disminución dolorosa y frustrante del sistema urinario. Las restricciones pueden ser causadas por infecciones, traumatismos y otros procedimientos médicos que lesionan el revestimiento de la uretra y pueden afectar significativamente la calidad de vida de los pacientes.

Peter Duffy, que ha recibido el tratamiento en Nueva Zelanda, donde Optilume está actualmente disponible, explica: "Estaba cansado de levantarme toda la noche para orinar, constantemente con antibióticos, y era incómodo orinar; por desgracia, después de una uretrotomía, sufrí de una estenosis recurrente. Estoy agradecido de haber encontrado Optilume y ahora puedo vivir una vida cómoda que puedo disfrutar."

Oliver Kayes, Consultor Urólogo, Leeds Teaching Hospitals NHS Trust, Reino Unido, comentó: "Ha habido una necesidad significativa de tratamientos nuevos y alternativos para la enfermedad de la estenosis uretral. Continuamente tenemos que desafiar cómo ofrecer los tratamientos más rentables para los hombres con estenosis de novo o recurrentes. Las terapias novedosas deben coincidir con las expectativas de los pacientes con respecto al éxito junto con las vías de atención acelerada y la recuperación siempre que sea posible. Los emocionantes primeros datos sugieren que Optilume puede mejorar significativamente las tasas de éxito, incluyendo una mayor durabilidad y potencialmente menos efectos secundarios sobre las técnicas convencionales de dilatación endoscópica o uretrotomía en los hombres".

David Perry, presidente y consejero delegado de Urotronic, Inc. declaró: "Estamos emocionados de presentar Optilume a los médicos europeos y sus pacientes que sufren de esta enfermedad debilitante. La tecnología tiene el potencial de reducir las cargas en todo el panorama sanitario europeo como un tratamiento que es fácil de aprender y que se puede realizar en un procedimiento ambulatorio corto".

Acerca de Urotronic, Inc.

Urotronic, Inc., con sede en Plymouth, Minnesota, Estados Unidos, es una empresa de dispositivos médicos en etapa temprana que actualmente lleva a cabo ensayos clínicos para apoyar la comercialización global de sus productos. La tecnología Optilume Drug Coated Balloon proporciona una opción de tratamiento mínimamente invasiva para hombres que sufren de condiciones del tracto urinario como estenosis uretral e hiperplasia prostática benigna (BPH). Para obtener más información sobre Urotronic Inc., y nuestros productos, visite urotronic.com

Contacto de medios: Justin Hartlen | +1-902-412-5090 | [email protected]

Referencias:

  1. Mann, R. A., Virasoro, R., DeLong, J. M., Estrella, R. E., Pichardo, M., Rodríguez Lay, R., Espino, G., Roth, J. D., & Elliott, S. P. (2020). A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Canadian Urological Association Journal, 15(2). https://doi.org/10.5489/cuaj.6661
  2. Alwaal A, Blaschko SD, McAninch JW, Breyer BN. Epidemiology of urethral strictures. Transl Androl Urol. 2014;3(2):209-213. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708169/ 

SOURCE Urotronic, Inc.

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