{"id":36754,"date":"2025-12-02T09:50:15","date_gmt":"2025-12-02T08:50:15","guid":{"rendered":"https:\/\/ggba.swiss\/artiria-medical-obtains-ce-mark-for-its-deflectable-guidewire\/"},"modified":"2025-12-02T09:54:25","modified_gmt":"2025-12-02T08:54:25","slug":"artiria-medical-obtient-le-marquage-ce-pour-son-guide-endovasculaire-deflectable","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/fr\/artiria-medical-obtient-le-marquage-ce-pour-son-guide-endovasculaire-deflectable\/","title":{"rendered":"Artiria Medical obtient le marquage CE pour son guide endovasculaire d\u00e9fl\u00e9ctable"},"content":{"rendered":"\n<p>La soci\u00e9t\u00e9 genevoise <a href=\"https:\/\/www.artiria-medical.com\/\">Artiria Medical<\/a> a obtenu la certification CE selon le R\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux (EU MDR) pour son SmartGUIDE 014, un guide endovasculaire nouvelle g\u00e9n\u00e9ration con\u00e7u pour les proc\u00e9dures neurovasculaires. Cette approbation, qui vient compl\u00e9ter l\u2019autorisation d\u00e9j\u00e0 accord\u00e9e par la FDA, ouvre \u00e0 l\u2019entreprise l\u2019acc\u00e8s simultan\u00e9 aux march\u00e9s europ\u00e9en et am\u00e9ricain et constitue une \u00e9tape majeure dans sa strat\u00e9gie de commercialisation.<\/p>\n\n\n\n<p>Le SmartGUIDE 014 est con\u00e7u pour aider les m\u00e9decins \u00e0 naviguer dans les vaisseaux c\u00e9r\u00e9braux \u00e9troits et tr\u00e8s tortueux lors d\u2019interventions pour AVC isch\u00e9miques et h\u00e9morragiques, ainsi que pour le traitement des an\u00e9vrismes. Avec un diam\u00e8tre de 0,014 pouce, le dispositif est compatible avec la majorit\u00e9 des syst\u00e8mes neurovasculaires utilis\u00e9s en pratique clinique, assurant une int\u00e9gration fluide dans les workflows existants.<\/p>\n\n\n\n<p>L\u2019un des \u00e9l\u00e9ments cl\u00e9s de la technologie r\u00e9side dans sa pointe distale articul\u00e9e, que les m\u00e9decins peuvent orienter et d\u00e9fl\u00e9chir dynamiquement en conditions r\u00e9elles. Cette capacit\u00e9 permet un acc\u00e8s plus s\u00fbr et plus efficace aux zones anatomiques neurovasculaires difficiles d\u2019acc\u00e8s. \u00ab La possibilit\u00e9 d\u2019ajuster et de d\u00e9fl\u00e9chir la pointe du SmartGUIDE en temps r\u00e9el non seulement rend cette technologie unique, mais am\u00e9liore \u00e9galement l\u2019acc\u00e8s aux cibles neurovasculaires complexes \u00bb, souligne le Dr Jan-Karl Burkhardt, responsable de la chirurgie c\u00e9r\u00e9brovasculaire \u00e0 l\u2019H\u00f4pital de l\u2019Universit\u00e9 de Pennsylvanie.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Lancement clinique et expansion commerciale<\/h4>\n\n\n\n<p>Selon l\u2019entreprise, l\u2019obtention du marquage CE fait suite \u00e0 une \u00e9valuation rigoureuse de la documentation technique et des donn\u00e9es cliniques du SmartGUIDE 014, confirmant sa conformit\u00e9 aux exigences strictes de s\u00e9curit\u00e9 et de performance de l\u2019EU MDR. Cette certification soutient les plans d\u2019Artiria Medical visant \u00e0 acc\u00e9l\u00e9rer la commercialisation et \u00e0 \u00e9tendre la disponibilit\u00e9 clinique du dispositif en Europe et aux \u00c9tats-Unis.<\/p>\n\n\n\n<p>Cette \u00e9tape r\u00e9glementaire intervient alors qu\u2019Artiria Medical b\u00e9n\u00e9ficie d\u2019une reconnaissance croissante au sein de l\u2019\u00e9cosyst\u00e8me des sciences de la vie en Suisse occidentale. Plus t\u00f4t cette ann\u00e9e, la soci\u00e9t\u00e9 a remport\u00e9 le <a href=\"https:\/\/ggba.swiss\/fr\/artiria-medical-et-reverso-therapeutics-recompenses-lors-du-bioinnovation-day-2025\/\">prix du \u00ab Best Startup Award \u00bb lors du BioInnovation Day 2025<\/a> \u00e0 Gen\u00e8ve pour sa plateforme robotique neurovasculaire destin\u00e9e \u00e0 am\u00e9liorer la pr\u00e9cision et l\u2019accessibilit\u00e9 des interventions en cas d\u2019AVC.<\/p>\n\n\n\n<p>Bas\u00e9e \u00e0 Gen\u00e8ve, avec des activit\u00e9s au de l\u2019<a href=\"https:\/\/www.epfl-innovationpark.ch\/\">EPFL Innovation Park<\/a> et au <a href=\"https:\/\/wysscenter.ch\/\">Wyss Center<\/a>, Artiria Medical d\u00e9veloppe des technologies mini-invasives pour le traitement des AVC isch\u00e9miques et h\u00e9morragiques, qui demeurent parmi les principales causes de handicap et de mortalit\u00e9 dans le monde.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Artiria Medical a obtenu le marquage CE pour son guide SmartGUIDE 014, ouvrant la voie \u00e0 sa commercialisation en Europe et \u00e0 une adoption clinique renforc\u00e9e dans le traitement des AVC et des an\u00e9vrismes.<\/p>\n","protected":false},"author":6,"featured_media":36751,"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":[1180,1188,1163],"class_list":["post-36754","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sciences-de-la-vie","tag-digital-health-fr-2","tag-healthcare-fr-2","tag-medtech-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>Artiria obtient le marquage CE pour son guide endovasculaire<\/title>\n<meta name=\"description\" content=\"Artiria Medical a obtenu le marquage CE pour son guide 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