La FDA designó como dispositivo innovador al sistema de modulación de red inteligente, mecanismo diseñado por la compañía InBrain Neuroelectronics. El asentimiento de avance cubre la plataforma grafeno-neural como una terapia adyuvante para el tratamiento de la enfermedad de Parkinson o párkinson, siendo el primer sistema de este tipo diseñado para esta enfermedad neurológica.
Según InBrain Neuroelectronics, la plataforma neural permite una resolución de señal ultraalta, utilizando software de aprendizaje automático para descodificar biomarcadores específicos de la terapia. Proporciona una terapia neuroelectrónica adaptativa y altamente focalizada que reequilibra las redes neuronales patológicas.
“La designación de dispositivo innovador por parte de la FDA significa el potencial de la plataforma neural INBRAIN para mejorar aún más la vida de los pacientes con la enfermedad de Parkinson”, dijo el Jefe de Asuntos Clínicos de INBRAIN Neuroelectronics, Dan Gnansia. “Esperamos trabajar con la agencia para ayudar a llevar este importante avance a la práctica clínica”, añadió.
Datos de la OMS indican que la enfermedad de Parkinson aumentó en los últimos años. En 2019, generó 5,8 millones de años de vida ajustados por discapacidad, lo que supone un incremento del 81% desde el año 2000. Además, se relacionó como el factor directo de 329,000 muertes, un aumento de más del 100% desde el año 2000.
¿Qué ventajas ofrece la plataforma para el tratamiento de la enfermedad de Parkinson?
La designación de avance reconoce aquellos dispositivos que representan un importante avance o proporcionan evidencia razonable de una ventaja significativa sobre las alternativas ya aprobadas o autorizadas. Además, acelera el proceso de desarrollo y revisión por parte de la FDA de nuevos dispositivos con el potencial de diagnosticar o tratar enfermedades potencialmente mortales o debilitantes de manera más eficaz.
“De las actuales interfaces cerebrales clínicas disponibles, la estimulación cerebral profunda es una terapia de éxito para tratar la enfermedad de Parkinson. Sin embargo, los cables actuales tienen restricciones en cuanto a su tamaño relativamente grande y su baja densidad, lo que limita su precisión para dirigirse a pequeñas estructuras profundas, como el núcleo subtalámico (NST), y la resolución espacial o de la señal cuando se detecta la actividad eléctrica cerebral local”, indica la compañía en su comunicado de prensa oficial.
El dispositivo en mención funciona con la interfaz cerebro-ordenador (BCI) derivada de semiconductores podría descodificar y modular la actividad cerebral. Pero, además, utiliza la inteligencia artificial para desencadenar respuestas adaptativas que permitan un tratamiento neurológico personalizado no solo para el parkinson, también para la epilepsia o la enfermedad de Alzheimer.
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