{"id":29842,"date":"2025-01-06T10:06:18","date_gmt":"2025-01-06T09:06:18","guid":{"rendered":"https:\/\/ggba.swiss\/onward-medical-receives-fda-authorization-for-its-spinal-cord-stimulation-system\/"},"modified":"2025-01-06T10:12:41","modified_gmt":"2025-01-06T09:12:41","slug":"onward-medical-recoit-une-autorisation-de-la-fda-pour-son-systeme-de-stimulation-de-la-moelle-epiniere","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/fr\/onward-medical-recoit-une-autorisation-de-la-fda-pour-son-systeme-de-stimulation-de-la-moelle-epiniere\/","title":{"rendered":"ONWARD Medical re\u00e7oit une autorisation de la FDA pour son syst\u00e8me de stimulation de la moelle \u00e9pini\u00e8re"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.onwd.com\/\">ONWARD Medical<\/a>, leader dans les th\u00e9rapies de stimulation de la moelle \u00e9pini\u00e8re, a re\u00e7u la classification de novo de la FDA et l&rsquo;autorisation de commercialiser son <a href=\"https:\/\/www.onwd.com\/therapy\/arc-ex\/\">syst\u00e8me ARC-EX<\/a> aux \u00c9tats-Unis. Cette autorisation repr\u00e9sente une perc\u00e9e dans le traitement des l\u00e9sions chroniques de la moelle \u00e9pini\u00e8re, en offrant la premi\u00e8re technologie approuv\u00e9e par la FDA dont il a \u00e9t\u00e9 d\u00e9montr\u00e9 qu&rsquo;elle am\u00e9liore la force et la sensation de la main chez les personnes souffrant d&rsquo;une l\u00e9sion m\u00e9dullaire de longue dur\u00e9e.<\/p>\n\n\n\n<p>Le syst\u00e8me ARC-EX fournit une stimulation \u00e9lectrique programm\u00e9e \u00e0 la moelle \u00e9pini\u00e8re par le biais d&rsquo;\u00e9lectrodes plac\u00e9es \u00e0 l&rsquo;arri\u00e8re du cou, offrant une th\u00e9rapie de mani\u00e8re totalement non invasive. Contrairement aux dispositifs traditionnels de stimulation de la moelle \u00e9pini\u00e8re qui n\u00e9cessitent une intervention chirurgicale, le syst\u00e8me ARC-EX se compose d&rsquo;un stimulateur externe et d&rsquo;un programmateur sans fil, ce qui permet d&rsquo;adapter les param\u00e8tres aux besoins de chaque patient.<\/p>\n\n\n\n<p>L&rsquo;approbation du syst\u00e8me ARC-EX fait suite au succ\u00e8s de l&rsquo;\u00e9tude clinique Up-LIFT, publi\u00e9e dans Nature Medicine. L&rsquo;\u00e9tude a d\u00e9montr\u00e9 que 90% des participants ont vu leur force ou leur fonction s&rsquo;am\u00e9liorer, et 87% ont fait \u00e9tat d&rsquo;une meilleure qualit\u00e9 de vie. Les avantages, notamment la r\u00e9duction de la fr\u00e9quence des spasmes, l&rsquo;am\u00e9lioration du sommeil et l&rsquo;augmentation des sensations, ont \u00e9t\u00e9 observ\u00e9s chez des participants dont les blessures remontaient \u00e0 34 ans.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Une nouvelle norme pour la th\u00e9rapie de la moelle \u00e9pini\u00e8re<\/h4>\n\n\n\n<p>\u00ab\u00a0Cette autorisation marque le d\u00e9but d&rsquo;une nouvelle \u00e8re pour les personnes vivant avec des l\u00e9sions chroniques de la moelle \u00e9pini\u00e8re \u00bb, a d\u00e9clar\u00e9 Dave Marver, CEO d&rsquo;ONWARD Medical. \u00ab Le syst\u00e8me ARC-EX repr\u00e9sente une \u00e9tape cruciale dans la restauration de l&rsquo;ind\u00e9pendance des personnes atteintes de paralysie et d&rsquo;autres handicaps moteurs.\u00a0\u00bb<\/p>\n\n\n\n<p>Autoris\u00e9 par la FDA dans le cadre de la <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/de-novo-classification-request\">proc\u00e9dure De Novo<\/a>, le syst\u00e8me ARC-EX est class\u00e9 comme un dispositif \u00e0 risque faible \u00e0 moyen sans ant\u00e9c\u00e9dent, ce qui garantit la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9 par le biais d&rsquo;une \u00e9valuation rigoureuse.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ONWARD Medical a franchi une \u00e9tape importante en obtenant de la FDA la classification de novo et l&rsquo;autorisation de mise sur le march\u00e9 de son syst\u00e8me non invasif ARC-EX, la premi\u00e8re technologie approuv\u00e9e pour am\u00e9liorer la force et la sensation de la main apr\u00e8s une l\u00e9sion chronique de la moelle \u00e9pini\u00e8re.<\/p>\n","protected":false},"author":6,"featured_media":29839,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[843],"tags":[1181,1163,1239,1141],"class_list":["post-29842","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sciences-de-la-vie","tag-medical-devices-fr","tag-medtech-fr-2","tag-neuroscience-fr-2","tag-personalized-medicine-fr-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ONWARD Medical re\u00e7oit une autorisation de la FDA | GGBa<\/title>\n<meta name=\"description\" content=\"ONWARD Medical a obtenu de la FDA la classification de novo et l&#039;autorisation de mise sur le march\u00e9 de son syst\u00e8me non invasif ARC-EX.\" \/>\n<meta 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