{"id":220,"date":"2013-04-09T16:07:43","date_gmt":"2013-04-09T20:07:43","guid":{"rendered":"http:\/\/demo.desertretina.com.php73-37.phx1-1.websitetestlink.com\/?p=220"},"modified":"2024-11-26T10:39:28","modified_gmt":"2024-11-26T15:39:28","slug":"fda-approves-first-retinal-implant-for-adults-with-rare-genetic-eye-disease","status":"publish","type":"post","link":"https:\/\/desertretina.com\/es\/fda-approves-first-retinal-implant-for-adults-with-rare-genetic-eye-disease\/","title":{"rendered":"La FDA aprueba el primer implante de retina para adultos con una enfermedad ocular gen\u00e9tica rara."},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) aprob\u00f3 hoy el Sistema de Pr\u00f3tesis Retiniana Argus II, el primer dispositivo implantable para el tratamiento de pacientes adultos con retinosis pigmentaria (RP) avanzada. El dispositivo, que incluye una peque\u00f1a c\u00e1mara de video, un transmisor montado en unas gafas, una unidad de procesamiento de video (VPU) y una pr\u00f3tesis retiniana implantada (retina artificial), reemplaza la funci\u00f3n de las c\u00e9lulas degeneradas de la retina (una membrana dentro del ojo) y puede mejorar la capacidad del paciente para percibir im\u00e1genes y movimiento. La VPU transforma las im\u00e1genes de la c\u00e1mara de video en datos electr\u00f3nicos que se transmiten de forma inal\u00e1mbrica a la pr\u00f3tesis retiniana.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"575\" height=\"400\" src=\"https:\/\/desertretina.com\/wp-content\/uploads\/Argus_ii_Implant_External.jpg\" alt=\"\" class=\"wp-image-221\" srcset=\"https:\/\/desertretina.com\/wp-content\/uploads\/Argus_ii_Implant_External.jpg 575w, https:\/\/desertretina.com\/wp-content\/uploads\/Argus_ii_Implant_External-300x209.jpg 300w, https:\/\/desertretina.com\/wp-content\/uploads\/Argus_ii_Implant_External-270x188.jpg 270w\" sizes=\"auto, (max-width: 575px) 100vw, 575px\" \/><\/figure>\n\n\n\n<p>La RP es una enfermedad ocular gen\u00e9tica poco com\u00fan que da\u00f1a las c\u00e9lulas fotosensibles que recubren la retina. En un ojo sano, estas c\u00e9lulas transforman los rayos de luz en impulsos el\u00e9ctricos y los env\u00edan a trav\u00e9s del nervio \u00f3ptico a la zona del cerebro que los ensambla para formar una imagen. En las personas con RP, las c\u00e9lulas fotosensibles se degeneran lentamente, lo que provoca la p\u00e9rdida gradual de la visi\u00f3n lateral y nocturna, y posteriormente de la visi\u00f3n central. Esta enfermedad puede provocar ceguera.<\/p>\n\n\n\n<p>\u201cEste nuevo dispositivo de asistencia implantable quir\u00fargicamente ofrece una opci\u00f3n para pacientes que han perdido la visi\u00f3n debido a la RP, para quienes no existen tratamientos aprobados por la FDA\u201d, afirm\u00f3 el Dr. Jeffrey Shuren, director del Centro de Dispositivos y Salud Radiol\u00f3gica de la FDA. \u201cEl dispositivo puede ayudar a los adultos con RP que han perdido la capacidad de percibir formas y movimientos a tener mayor movilidad y realizar actividades cotidianas\u201d.\u201d<\/p>\n\n\n\n<p>El sistema Argus II est\u00e1 dise\u00f1ado para adultos mayores de 25 a\u00f1os con RP de severa a profunda, con percepci\u00f3n de luz pura (perciben la luz, pero no la direcci\u00f3n de donde proviene) o nula en ambos ojos, con evidencia de funci\u00f3n intacta de la capa interna de la retina y antecedentes de visi\u00f3n de formas. Los pacientes tambi\u00e9n deben estar dispuestos y ser capaces de recibir el seguimiento cl\u00ednico postimplante, la adaptaci\u00f3n del dispositivo y la rehabilitaci\u00f3n visual recomendados.<\/p>\n\n\n\n<p>Adem\u00e1s de una peque\u00f1a c\u00e1mara de video y un transmisor montados en las gafas, el sistema de pr\u00f3tesis de retina Argus II cuenta con una unidad de procesamiento de video (VPU) port\u00e1til y un conjunto de electrodos que se implantan en la retina del paciente. La VPU transforma las im\u00e1genes de la c\u00e1mara de video en datos electr\u00f3nicos que se transmiten inal\u00e1mbricamente a los electrodos. Los electrodos transforman los datos en impulsos el\u00e9ctricos que estimulan la retina para producir im\u00e1genes. Si bien el sistema de pr\u00f3tesis de retina Argus II no restaura la visi\u00f3n, puede permitirles detectar la luz y la oscuridad en el entorno, lo que les ayuda a identificar la ubicaci\u00f3n o el movimiento de objetos o personas.<\/p>\n\n\n\n<p>La FDA aprob\u00f3 el sistema de pr\u00f3tesis de retina Argus II como dispositivo de uso humanitario, un proceso de aprobaci\u00f3n limitado a aquellos dispositivos que tratan o diagnostican a menos de 4000 personas en Estados Unidos cada a\u00f1o. Para obtener la aprobaci\u00f3n para uso humanitario, la empresa debe demostrar una garant\u00eda razonable de que el dispositivo es seguro y que su probable beneficio supera el riesgo de enfermedad o lesi\u00f3n. La empresa tambi\u00e9n debe demostrar que no existe un dispositivo comparable disponible para tratar o diagnosticar la enfermedad o afecci\u00f3n.<\/p>\n\n\n\n<p>La FDA revis\u00f3 datos de un estudio cl\u00ednico con 30 participantes con RP que recibieron el sistema de pr\u00f3tesis de retina Argus II. Los investigadores monitorearon a los participantes para detectar eventos adversos relacionados con el dispositivo o la cirug\u00eda del implante y evaluaron peri\u00f3dicamente su visi\u00f3n durante al menos dos a\u00f1os despu\u00e9s de recibir el implante.<\/p>\n\n\n\n<p>Los resultados del estudio cl\u00ednico muestran que la mayor\u00eda de los participantes realizaron mejor las actividades b\u00e1sicas con el sistema de pr\u00f3tesis de retina Argus II que sin \u00e9l. Algunas de las actividades evaluadas incluyeron localizar y tocar un cuadrado en un campo blanco; detectar la direcci\u00f3n de un movimiento; reconocer letras, palabras u oraciones grandes; detectar bordillos; caminar por una acera sin bajarse; y combinar calcetines negros, grises y blancos.<\/p>\n\n\n\n<p>Tras la cirug\u00eda de implante, 19 de los 30 pacientes del estudio no experimentaron ning\u00fan efecto adverso relacionado con el dispositivo ni con la cirug\u00eda. Once sujetos del estudio experimentaron un total de 23 efectos adversos graves, entre ellos erosi\u00f3n de la conjuntiva (la membrana transparente que recubre el globo ocular), dehiscencia (apertura de una herida a lo largo de la sutura quir\u00fargica), desprendimiento de retina, inflamaci\u00f3n e hipoton\u00eda (baja presi\u00f3n intraocular).<\/p>\n\n\n\n<p>Tres organizaciones gubernamentales apoyaron el desarrollo del Argus II. El Departamento de Energ\u00eda, el Instituto Nacional del Ojo de los Institutos Nacionales de la Salud y la Fundaci\u00f3n Nacional de la Ciencia colaboraron para proporcionar subvenciones por un total de m\u00e1s de 100 millones de d\u00f3lares, as\u00ed como apoyo para el dise\u00f1o de materiales y otras investigaciones b\u00e1sicas para el proyecto.<\/p>\n\n\n\n<p>Second Sight Medical Products, Inc. tiene su sede en Sylmar, California.<\/p>\n\n\n\n<p><br>Para obtener m\u00e1s informaci\u00f3n, visite\u00a0<a href=\"https:\/\/www.fda.gov\/MedicalDevices\/default.htm\">Dispositivos m\u00e9dicos de la FDA<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU), and an implanted retinal prosthesis (artificial retina), replaces the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":236,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-220","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves First Retinal Implant For Adults With Rare Genetic Eye Disease | Desert Retina Consultants<\/title>\n<meta name=\"description\" content=\"FDA Approves First Retinal Implant For Adults With Rare Genetic Eye Disease. 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