{"id":5832,"date":"2024-10-18T13:03:58","date_gmt":"2024-10-18T11:03:58","guid":{"rendered":"https:\/\/sedanamedical.com\/nos-recherches\/"},"modified":"2025-05-15T10:20:03","modified_gmt":"2025-05-15T08:20:03","slug":"nos-recherches","status":"publish","type":"page","link":"https:\/\/sedanamedical.com\/fr\/nos-recherches\/","title":{"rendered":"Nos recherches"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00a0\u00bb1&Prime; custom_padding_last_edited=\u00a0\u00bbon|desktop\u00a0\u00bb admin_label=\u00a0\u00bbHero Section\u00a0\u00bb module_class=\u00a0\u00bbhero-section\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb background_color=\u00a0\u00bb#002145&Prime; background_image=\u00a0\u00bbhttps:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/11\/Bedside_v3_Highres.jpg\u00a0\u00bb background_blend=\u00a0\u00bbsoft-light\u00a0\u00bb custom_padding=\u00a0\u00bb120px|20px|120px|20px|false|true\u00a0\u00bb custom_padding_tablet=\u00a0\u00bb120px|20px|120px|20px|false|true\u00a0\u00bb custom_padding_phone=\u00a0\u00bb80px||80px||true|true\u00a0\u00bb da_disable_devices=\u00a0\u00bboff|off|off\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb collapsed=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb da_is_popup=\u00a0\u00bboff\u00a0\u00bb da_exit_intent=\u00a0\u00bboff\u00a0\u00bb da_has_close=\u00a0\u00bbon\u00a0\u00bb da_alt_close=\u00a0\u00bboff\u00a0\u00bb da_dark_close=\u00a0\u00bboff\u00a0\u00bb da_not_modal=\u00a0\u00bbon\u00a0\u00bb da_is_singular=\u00a0\u00bboff\u00a0\u00bb da_with_loader=\u00a0\u00bboff\u00a0\u00bb da_has_shadow=\u00a0\u00bbon\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.27.0&Prime; 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_builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb da_disable_devices=\u00a0\u00bboff|off|off\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb da_is_popup=\u00a0\u00bboff\u00a0\u00bb da_exit_intent=\u00a0\u00bboff\u00a0\u00bb da_has_close=\u00a0\u00bbon\u00a0\u00bb da_alt_close=\u00a0\u00bboff\u00a0\u00bb da_dark_close=\u00a0\u00bboff\u00a0\u00bb da_not_modal=\u00a0\u00bbon\u00a0\u00bb da_is_singular=\u00a0\u00bboff\u00a0\u00bb da_with_loader=\u00a0\u00bboff\u00a0\u00bb da_has_shadow=\u00a0\u00bbon\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb custom_padding=\u00a0\u00bb||66px||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_heading title=\u00a0\u00bb\u00c9tudes cliniques de Sedana Medical\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb title_font=\u00a0\u00bbSofia Pro Light|||on|||||\u00a0\u00bb title_text_align=\u00a0\u00bbcenter\u00a0\u00bb title_text_color=\u00a0\u00bb#009ee6&Prime; title_font_size_tablet=\u00a0\u00bb\u00a0\u00bb title_font_size_phone=\u00a0\u00bb\u00a0\u00bb title_font_size_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_heading][et_pb_text _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb text_font=\u00a0\u00bbSofia Pro Light||||||||\u00a0\u00bb text_font_size=\u00a0\u00bb21px\u00a0\u00bb text_line_height=\u00a0\u00bb1.8em\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>Nous croyons au travail en partenariat dans nos projets de recherche, dans le but de poursuivre le d\u00e9veloppement et les avanc\u00e9es m\u00e9dicales au profit des patients en soins intensifs.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_image src=\u00a0\u00bbhttps:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/10\/lungs-new-blue-6BC4E9.png\u00a0\u00bb alt=\u00a0\u00bbpoumons-nouveau-bleu-6BC4E9&Prime; title_text=\u00a0\u00bbpoumons-nouveau-bleu-6BC4E9&Prime; align=\u00a0\u00bbcenter\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb background_color=\u00a0\u00bb#f8f8f8&Prime; max_width=\u00a0\u00bb1296px\u00a0\u00bb max_width_tablet=\u00a0\u00bb1296px\u00a0\u00bb max_width_phone=\u00a0\u00bb1296px\u00a0\u00bb max_width_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_margin=\u00a0\u00bb||80px||false|false\u00a0\u00bb custom_margin_tablet=\u00a0\u00bb||80px||false|false\u00a0\u00bb custom_margin_phone=\u00a0\u00bb||80px||false|false\u00a0\u00bb custom_margin_last_edited=\u00a0\u00bbon|phone\u00a0\u00bb custom_padding=\u00a0\u00bb||||false|false\u00a0\u00bb box_shadow_style=\u00a0\u00bbpreset3&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_toggle title=\u00a0\u00bbProgramme(s) d&#039;acc\u00e8s anticip\u00e9\u00a0\u00bb open_toggle_text_color=\u00a0\u00bb#009ee6&Prime; open_toggle_background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb closed_toggle_background_color=\u00a0\u00bb#f8f8f8&Prime; icon_color=\u00a0\u00bb#009ee6&Prime; toggle_icon=\u00a0\u00bb&#x4c;||divi||400&Prime; use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb icon_font_size=\u00a0\u00bb25px\u00a0\u00bb open_icon_color=\u00a0\u00bb#009ee6&Prime; open_toggle_icon=\u00a0\u00bb&#x4b;||divi||400&Prime; open_use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb open_icon_font_size=\u00a0\u00bb25px\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb title_text_color=\u00a0\u00bb#666666&Prime; title_level=\u00a0\u00bbh2&Prime; title_font=\u00a0\u00bbSofia Pro Light|500||on|||||\u00a0\u00bb title_text_align=\u00a0\u00bbleft\u00a0\u00bb title_font_size=\u00a0\u00bb21px\u00a0\u00bb closed_title_font=\u00a0\u00bbSofia Pro Light|||on|||||\u00a0\u00bb closed_title_font_size=\u00a0\u00bb18px\u00a0\u00bb body_font=\u00a0\u00bbSofia Pro Light||||||||\u00a0\u00bb body_text_align=\u00a0\u00bbleft\u00a0\u00bb body_font_size=\u00a0\u00bb18px\u00a0\u00bb background_color=\u00a0\u00bb#f8f8f8&Prime; background_enable_image=\u00a0\u00bboff\u00a0\u00bb background_size=\u00a0\u00bbcustom\u00a0\u00bb background_image_width=\u00a0\u00bb0%\u00a0\u00bb background_image_height=\u00a0\u00bb125%\u00a0\u00bb background_position=\u00a0\u00bbcenter_right\u00a0\u00bb background_horizontal_offset=\u00a0\u00bb7%\u00a0\u00bb border_width_all=\u00a0\u00bb0px\u00a0\u00bb border_style_all=\u00a0\u00bbdouble\u00a0\u00bb border_width_bottom=\u00a0\u00bb1px\u00a0\u00bb border_color_bottom=\u00a0\u00bb#D6D6D6&Prime; border_style_bottom=\u00a0\u00bbsolid\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p>Sedana Medical AB (publ) (\u00ab\u00a0Sedana Medical\u00a0\u00bb) est une soci\u00e9t\u00e9 pionni\u00e8re dans le domaine des technologies m\u00e9dicales et pharmaceutiques, sp\u00e9cialis\u00e9e dans la s\u00e9dation par inhalation pour les patients sous ventilation m\u00e9canique en soins intensifs.<\/p>\n<h3>Objectif<\/h3>\n<p>Sedana Medical s&rsquo;engage, par le biais d&rsquo;une science innovante, \u00e0 am\u00e9liorer la vie du patient pendant et apr\u00e8s la s\u00e9dation. La s\u00e9curit\u00e9 des patients est primordiale et l&rsquo;objectif est de fournir des th\u00e9rapies aux patients qui pourraient en b\u00e9n\u00e9ficier sans les exposer \u00e0 des risques excessifs. <\/p>\n<p>Sedana Medical estime que les m\u00e9dicaments exp\u00e9rimentaux (non encore approuv\u00e9s par les autorit\u00e9s sanitaires comp\u00e9tentes) doivent \u00eatre \u00e9tudi\u00e9s sur des patients dans le cadre d&rsquo;essais cliniques destin\u00e9s \u00e0 g\u00e9n\u00e9rer des donn\u00e9es sur la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9. Ces donn\u00e9es peuvent \u00eatre utilis\u00e9es pour \u00e9tayer les demandes r\u00e9glementaires, ce qui aboutit finalement \u00e0 de nouveaux m\u00e9dicaments approuv\u00e9s. Sedana Medical encourage le dialogue entre les patients et leurs m\u00e9decins afin de trouver des opportunit\u00e9s de participer \u00e0 des essais cliniques dans la mesure du possible.  <\/p>\n<p>Dans certains cas, les patients ne sont pas \u00e9ligibles pour les essais cliniques en cours, ou les essais cliniques peuvent ne pas \u00eatre recrut\u00e9s dans leur r\u00e9gion g\u00e9ographique. En outre, les m\u00e9dicaments exp\u00e9rimentaux peuvent ne pas \u00eatre disponibles entre la fin des essais cliniques d&rsquo;enregistrement et l&rsquo;approbation r\u00e9glementaire ou la disponibilit\u00e9 commerciale. Lorsque les patients ont \u00e9puis\u00e9 toutes les th\u00e9rapies disponibles, Sedana Medical peut envisager de fournir un m\u00e9dicament exp\u00e9rimental en dehors d&rsquo;un essai clinique dans le cadre d&rsquo;un programme d&rsquo;acc\u00e8s anticip\u00e9.  <\/p>\n<h3>Informations g\u00e9n\u00e9rales sur les programmes d&rsquo;acc\u00e8s anticip\u00e9<\/h3>\n<p>Il existe une vari\u00e9t\u00e9 de r\u00e9glementations et de m\u00e9canismes locaux pour fournir des produits exp\u00e9rimentaux avant l&rsquo;approbation r\u00e9glementaire ou l&rsquo;acc\u00e8s commercial. Diff\u00e9rents termes existent localement pour d\u00e9signer ces dispositions d&rsquo;acc\u00e8s avant approbation, notamment \u00ab\u00a0Compassionate Use Program\u00a0\u00bb, \u00ab\u00a0Expanded Access Program\u00a0\u00bb, \u00ab\u00a0Named Patient Program\u00a0\u00bb, \u00ab\u00a0Special Access Schemes\/Programs\u00a0\u00bb (programmes d&rsquo;acc\u00e8s sp\u00e9ciaux). Chez Sedana Medical, les \u00ab\u00a0programmes d&rsquo;acc\u00e8s pr\u00e9coce\u00a0\u00bb (EAP) d\u00e9signent les m\u00e9canismes permettant d&rsquo;acc\u00e9der \u00e0 un produit en dehors des essais cliniques et avant l&rsquo;approbation r\u00e9glementaire et la mise sur le march\u00e9. Un programme d&rsquo;acc\u00e8s pr\u00e9coce (EAP) est destin\u00e9 \u00e0 fournir un acc\u00e8s et un approvisionnement \u00e0 des fins humanitaires pour un m\u00e9dicament exp\u00e9rimental lorsqu&rsquo;il existe des preuves qu&rsquo;un patient peut b\u00e9n\u00e9ficier d&rsquo;un traitement avant l&rsquo;approbation r\u00e9glementaire et la disponibilit\u00e9 commerciale du m\u00e9dicament.   <\/p>\n<p>Les programmes de cohorte de Sedana Medical n&rsquo;auront lieu que dans les pays o\u00f9 Sedana Medical a l&rsquo;intention de demander une approbation r\u00e9glementaire. L&rsquo;approbation de l&rsquo;agence locale des produits m\u00e9dicaux ou d&rsquo;une autre autorit\u00e9 comp\u00e9tente sera demand\u00e9e pour l&rsquo;une ou l&rsquo;autre voie d&rsquo;acc\u00e8s pr\u00e9coce. <\/p>\n<p>&nbsp;<\/p>\n<h3>Crit\u00e8res g\u00e9n\u00e9raux<\/h3>\n<p>Sedana Medical \u00e9valuera les crit\u00e8res suivants avant de mettre en place un programme (lorsque la r\u00e9glementation locale l&rsquo;autorise) ou d&rsquo;examiner les demandes individuelles des patients :<\/p>\n<ul>\n<li>Le type sp\u00e9cifique de programme propos\u00e9 est autoris\u00e9 conform\u00e9ment aux r\u00e9glementations et lois locales.<\/li>\n<li>Le m\u00e9dicament exp\u00e9rimental n&rsquo;est pas disponible dans le commerce pour l&rsquo;indication demand\u00e9e dans le pays concern\u00e9.<\/li>\n<li>Le patient n&rsquo;est pas \u00e9ligible ou n&rsquo;a pas acc\u00e8s \u00e0 une \u00e9tude clinique en cours sur le m\u00e9dicament exp\u00e9rimental.<\/li>\n<li>Le m\u00e9dicament exp\u00e9rimental doit faire l&rsquo;objet d&rsquo;une approbation r\u00e9glementaire.<\/li>\n<li>L&rsquo;acc\u00e8s pr\u00e9coce ne peut \u00eatre accord\u00e9 si les preuves cliniques du b\u00e9n\u00e9fice de l&rsquo;utilisation d&rsquo;un m\u00e9dicament exp\u00e9rimental sont encore insuffisantes ou si le traitement pr\u00e9sente ou est susceptible de pr\u00e9senter un risque inacceptable ou excessif pour le patient.<\/li>\n<li>Le m\u00e9dicament exp\u00e9rimental sera utilis\u00e9 comme traitement d&rsquo;une maladie grave ou mettant en jeu le pronostic vital, telle que d\u00e9finie par les lois et r\u00e8glements du pays concern\u00e9.<\/li>\n<li>Le patient en question ne peut pas \u00eatre trait\u00e9 de mani\u00e8re satisfaisante avec d&rsquo;autres m\u00e9dicaments approuv\u00e9s et disponibles dans le commerce pour la m\u00eame indication.<\/li>\n<li>Les demandes de m\u00e9dicaments exp\u00e9rimentaux dans le cadre d&rsquo;un PAE doivent \u00e9maner d&rsquo;un m\u00e9decin d\u00fbment qualifi\u00e9 et autoris\u00e9 \u00e0 exercer dans le pays o\u00f9 le m\u00e9dicament exp\u00e9rimental doit \u00eatre distribu\u00e9.<\/li>\n<li>Le(s) m\u00e9decin(s) traitant(s) doit (doivent) \u00eatre qualifi\u00e9(s) pour administrer le m\u00e9dicament exp\u00e9rimental et respecter toutes les exigences et proc\u00e9dures de s\u00e9curit\u00e9 pertinentes.<\/li>\n<li>Le m\u00e9decin traitant du\/des patient(s) pour lequel\/lesquels l&rsquo;acc\u00e8s est demand\u00e9 accepte de se conformer \u00e0 toutes les exigences l\u00e9gales et r\u00e9glementaires locales applicables en relation avec la demande, ainsi qu&rsquo;\u00e0 toutes les exigences en termes de crit\u00e8res d&rsquo;\u00e9ligibilit\u00e9, de rapports de s\u00e9curit\u00e9 ou d&rsquo;autres donn\u00e9es fournies, telles que stipul\u00e9es par Sedana Medical.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Cl\u00f4ture du programme d&rsquo;acc\u00e8s anticip\u00e9<\/h3>\n<p>Sedana Medical peut envisager de mettre fin \u00e0 un programme pour diverses raisons li\u00e9es au m\u00e9dicament exp\u00e9rimental, y compris, mais sans s&rsquo;y limiter, les suivantes<\/p>\n<ul>\n<li>Disponibilit\u00e9 commerciale pour un besoin ou une condition particuli\u00e8re<\/li>\n<\/ul>\n<ul>\n<li>Une d\u00e9cision r\u00e9glementaire n\u00e9gative<\/li>\n<li>De nouvelles informations sont disponibles sur la s\u00e9curit\u00e9 qui pourraient modifier de mani\u00e8re substantielle le profil b\u00e9n\u00e9fice\/risque.<\/li>\n<li>Approvisionnement limit\u00e9 ou autres probl\u00e8mes de fabrication<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Proc\u00e9dure de demande d&rsquo;acc\u00e8s<\/h3>\n<p>Nous avons actuellement un programme d&rsquo;acc\u00e8s \u00e9largi ouvert aux \u00c9tats-Unis.<\/p>\n<p>Les demandes d&rsquo;acc\u00e8s anticip\u00e9 doivent \u00eatre soumises par le m\u00e9decin traitant agr\u00e9\u00e9 et doivent inclure suffisamment de d\u00e9tails pour permettre \u00e0 Sedana Medical d&rsquo;\u00e9valuer la demande d&rsquo;acc\u00e8s anticip\u00e9. Veuillez indiquer vos coordonn\u00e9es, y compris l&rsquo;adresse, le num\u00e9ro de t\u00e9l\u00e9phone et l&rsquo;adresse \u00e9lectronique. Veuillez noter qu&rsquo;une formation est n\u00e9cessaire et que l&rsquo;\u00e9valuation d&rsquo;une demande d\u00e9pend \u00e9galement de nos ressources de formation.  <\/p>\n<p>Informations de contact :<\/p>\n<p>Sedana Medicals Global Medical Information :<span> <\/span><a href=\"mailto:medinfo@sedanamedical.com\">medinfo@sedanamedical.com.<\/a><\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=\u00a0\u00bbThe INSPiRE-ICU 1 &amp; INSPiRE-ICU 2&Prime; open_toggle_text_color=\u00a0\u00bb#009ee6&Prime; open_toggle_background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb closed_toggle_background_color=\u00a0\u00bb#f8f8f8&Prime; icon_color=\u00a0\u00bb#009ee6&Prime; toggle_icon=\u00a0\u00bb&#x4c;||divi||400&Prime; use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb icon_font_size=\u00a0\u00bb25px\u00a0\u00bb open_icon_color=\u00a0\u00bb#009ee6&Prime; open_toggle_icon=\u00a0\u00bb&#x4b;||divi||400&Prime; open_use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb open_icon_font_size=\u00a0\u00bb25px\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb title_text_color=\u00a0\u00bb#666666&Prime; title_level=\u00a0\u00bbh2&Prime; title_font=\u00a0\u00bbSofia Pro Light|500||on|||||\u00a0\u00bb title_text_align=\u00a0\u00bbleft\u00a0\u00bb title_font_size=\u00a0\u00bb21px\u00a0\u00bb closed_title_font=\u00a0\u00bbSofia Pro Light|||on|||||\u00a0\u00bb closed_title_font_size=\u00a0\u00bb18px\u00a0\u00bb body_font=\u00a0\u00bbSofia Pro Light||||||||\u00a0\u00bb body_text_align=\u00a0\u00bbleft\u00a0\u00bb body_font_size=\u00a0\u00bb18px\u00a0\u00bb background_color=\u00a0\u00bb#f8f8f8&Prime; background_enable_image=\u00a0\u00bboff\u00a0\u00bb background_size=\u00a0\u00bbcustom\u00a0\u00bb background_image_width=\u00a0\u00bb0%\u00a0\u00bb background_image_height=\u00a0\u00bb125%\u00a0\u00bb background_position=\u00a0\u00bbcenter_right\u00a0\u00bb background_horizontal_offset=\u00a0\u00bb7%\u00a0\u00bb border_width_all=\u00a0\u00bb0px\u00a0\u00bb border_style_all=\u00a0\u00bbdouble\u00a0\u00bb border_width_bottom=\u00a0\u00bb1px\u00a0\u00bb border_color_bottom=\u00a0\u00bb#D6D6D6&Prime; border_style_bottom=\u00a0\u00bbsolid\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p>Les \u00e9tudes INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) (SED003 et SED004) sont deux \u00e9tudes de phase III identiques visant \u00e0 confirmer l&rsquo;efficacit\u00e9 et la s\u00e9curit\u00e9 de l&rsquo;isoflurane inhal\u00e9, administr\u00e9 via le Sedaconda ACD, pour la s\u00e9dation des patients adultes ventil\u00e9s m\u00e9caniquement en USI, en comparaison avec la perfusion intraveineuse de propofol.<\/p>\n<p>Les r\u00e9sultats de ces \u00e9tudes serviront de base au d\u00e9p\u00f4t d&rsquo;une demande d&rsquo;autorisation de mise sur le march\u00e9 (NDA) aupr\u00e8s de la Food and Drug Administration (FDA) des \u00c9tats-Unis.<\/p>\n<p>Le crit\u00e8re d&rsquo;\u00e9valuation principal sera la proportion de temps pass\u00e9 dans la fourchette cible de profondeur de s\u00e9dation en l&rsquo;absence de s\u00e9dation de secours, telle qu&rsquo;\u00e9valu\u00e9e selon l&rsquo;\u00e9chelle d&rsquo;agitation et de s\u00e9dation de Richmond (Richmond Agitation Sedation Scale &#8211; RASS). En outre, les \u00e9tudes porteront sur plusieurs crit\u00e8res d&rsquo;\u00e9valuation secondaires, notamment l&rsquo;utilisation d&rsquo;opio\u00efdes, l&rsquo;heure de r\u00e9veil, la r\u00e9cup\u00e9ration cognitive apr\u00e8s la fin de la s\u00e9dation et l&rsquo;effort respiratoire spontan\u00e9. <\/p>\n<p>Les \u00e9tudes porteront sur un total de 470 patients adultes r\u00e9partis sur 25 \u00e0 30 sites aux \u00c9tats-Unis. Le premier patient a \u00e9t\u00e9 recrut\u00e9 en avril 2022. <\/p>\n<p>De plus amples informations sur les \u00e9tudes sont disponibles sur le site <a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05312385\" target=\"_blank\" rel=\"noopener\">www.clinicaltrials.gov<\/a> (<span class=\"wixui-rich-text__text\"><a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05312385\" target=\"_blank\" rel=\"noopener\">NCT05312385<\/a><\/span> pour SED003 et <span class=\"wixui-rich-text__text\"><a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05327296\" target=\"_blank\" rel=\"noopener\">NCT05327296<\/a><\/span> pour SED004).<\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=\u00a0\u00bbThe IsoCOMFORT study\u00a0\u00bb open_toggle_text_color=\u00a0\u00bb#009ee6&Prime; open_toggle_background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb closed_toggle_background_color=\u00a0\u00bb#f8f8f8&Prime; icon_color=\u00a0\u00bb#009ee6&Prime; toggle_icon=\u00a0\u00bb&#x4c;||divi||400&Prime; use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb icon_font_size=\u00a0\u00bb25px\u00a0\u00bb open_icon_color=\u00a0\u00bb#009ee6&Prime; open_toggle_icon=\u00a0\u00bb&#x4b;||divi||400&Prime; open_use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb open_icon_font_size=\u00a0\u00bb25px\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb title_text_color=\u00a0\u00bb#666666&Prime; title_level=\u00a0\u00bbh2&Prime; title_font=\u00a0\u00bbSofia Pro Light|500||on|||||\u00a0\u00bb title_text_align=\u00a0\u00bbleft\u00a0\u00bb title_font_size=\u00a0\u00bb21px\u00a0\u00bb closed_title_font=\u00a0\u00bbSofia Pro Light|||on|||||\u00a0\u00bb closed_title_font_size=\u00a0\u00bb18px\u00a0\u00bb body_font=\u00a0\u00bbSofia Pro Light||||||||\u00a0\u00bb body_text_align=\u00a0\u00bbleft\u00a0\u00bb body_font_size=\u00a0\u00bb18px\u00a0\u00bb background_color=\u00a0\u00bb#f8f8f8&Prime; background_enable_image=\u00a0\u00bboff\u00a0\u00bb background_size=\u00a0\u00bbcustom\u00a0\u00bb background_image_width=\u00a0\u00bb0%\u00a0\u00bb background_image_height=\u00a0\u00bb125%\u00a0\u00bb background_position=\u00a0\u00bbcenter_right\u00a0\u00bb background_horizontal_offset=\u00a0\u00bb7%\u00a0\u00bb border_width_all=\u00a0\u00bb0px\u00a0\u00bb border_style_all=\u00a0\u00bbdouble\u00a0\u00bb border_width_bottom=\u00a0\u00bb1px\u00a0\u00bb border_color_bottom=\u00a0\u00bb#D6D6D6&Prime; border_style_bottom=\u00a0\u00bbsolid\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p>En 2021, Sedana Medical a lanc\u00e9 l&rsquo;\u00e9tude IsoCOMFORT (SED002), une \u00e9tude p\u00e9diatrique de phase III visant \u00e0 d\u00e9terminer si la s\u00e9dation par Sedaconda (isoflurane) administr\u00e9e par l&rsquo;ACD Sedaconda est s\u00fbre et plus efficace que le midazolam administr\u00e9 par voie intraveineuse chez les patients p\u00e9diatriques \u00e2g\u00e9s de 3 \u00e0 17 ans et ventil\u00e9s m\u00e9caniquement en USI.<\/p>\n<p>Actuellement, le midazolam est la seule option de s\u00e9dation pour les enfants en soins intensifs, car le propofol est contre-indiqu\u00e9 en raison du risque d&rsquo;effets ind\u00e9sirables graves. Les patients seront s\u00e9dat\u00e9s pendant 12 \u00e0 48 heures avec l&rsquo;une ou l&rsquo;autre m\u00e9thode de s\u00e9dation, et le crit\u00e8re d&rsquo;\u00e9valuation principal sera la proportion de temps pass\u00e9 \u00e0 une profondeur de s\u00e9dation ad\u00e9quate. <\/p>\n<p>L&rsquo;\u00e9tude portera sur 160 patients provenant de cliniques de soins intensifs en Allemagne, en France, en Espagne, en Su\u00e8de et au Royaume-Uni. Les r\u00e9sultats de l&rsquo;\u00e9tude devraient d\u00e9boucher sur une indication p\u00e9diatrique approuv\u00e9e pour la s\u00e9dation par inhalation. <\/p>\n<p>Le recrutement des patients s&rsquo;est achev\u00e9 en 2023.<\/p>\n<p>De plus amples informations sur l&rsquo;\u00e9tude sont disponibles sur le site <a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT04684238\" target=\"_blank\" rel=\"noopener\">www.clinicaltrials.gov<\/a> (NCT04684238).<\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=\u00a0\u00bbThe Sedaconda Study\u00a0\u00bb open_toggle_text_color=\u00a0\u00bb#009ee6&Prime; open_toggle_background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb closed_toggle_background_color=\u00a0\u00bb#f8f8f8&Prime; icon_color=\u00a0\u00bb#009ee6&Prime; toggle_icon=\u00a0\u00bb&#x4c;||divi||400&Prime; use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb icon_font_size=\u00a0\u00bb25px\u00a0\u00bb open_icon_color=\u00a0\u00bb#009ee6&Prime; open_toggle_icon=\u00a0\u00bb&#x4b;||divi||400&Prime; open_use_icon_font_size=\u00a0\u00bbon\u00a0\u00bb open_icon_font_size=\u00a0\u00bb25px\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.0&Prime; _module_preset=\u00a0\u00bbdefault\u00a0\u00bb title_text_color=\u00a0\u00bb#666666&Prime; title_level=\u00a0\u00bbh2&Prime; title_font=\u00a0\u00bbSofia Pro Light|500||on|||||\u00a0\u00bb title_text_align=\u00a0\u00bbleft\u00a0\u00bb title_font_size=\u00a0\u00bb21px\u00a0\u00bb closed_title_font=\u00a0\u00bbSofia Pro Light|||on|||||\u00a0\u00bb closed_title_font_size=\u00a0\u00bb18px\u00a0\u00bb body_font=\u00a0\u00bbSofia Pro Light||||||||\u00a0\u00bb body_text_align=\u00a0\u00bbleft\u00a0\u00bb body_font_size=\u00a0\u00bb18px\u00a0\u00bb background_color=\u00a0\u00bb#f8f8f8&Prime; background_enable_image=\u00a0\u00bboff\u00a0\u00bb background_size=\u00a0\u00bbcustom\u00a0\u00bb background_image_width=\u00a0\u00bb0%\u00a0\u00bb background_image_height=\u00a0\u00bb125%\u00a0\u00bb background_position=\u00a0\u00bbcenter_right\u00a0\u00bb background_horizontal_offset=\u00a0\u00bb7%\u00a0\u00bb border_width_all=\u00a0\u00bb0px\u00a0\u00bb border_style_all=\u00a0\u00bbdouble\u00a0\u00bb border_width_bottom=\u00a0\u00bb1px\u00a0\u00bb border_color_bottom=\u00a0\u00bb#D6D6D6&Prime; border_style_bottom=\u00a0\u00bbsolid\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p>En 2020, Sedana Medical a achev\u00e9 l&rsquo;\u00e9tude Sedaconda (SED001), la plus grande \u00e9tude randomis\u00e9e, contr\u00f4l\u00e9e et ouverte r\u00e9alis\u00e9e \u00e0 ce jour sur la s\u00e9dation par inhalation en soins intensifs.<\/p>\n<p>L&rsquo;\u00e9tude de phase III visait \u00e0 confirmer l&rsquo;efficacit\u00e9 et la s\u00e9curit\u00e9 de la s\u00e9dation par Sedaconda (isoflurane) administr\u00e9 via le Sedaconda ACD chez des patients en soins intensifs sous ventilation m\u00e9canique, en la comparant \u00e0 la s\u00e9dation standard par propofol administr\u00e9 par voie intraveineuse. Au total, 301 patients de 24 cliniques de soins intensifs d&rsquo;Allemagne et de Slov\u00e9nie ont \u00e9t\u00e9 randomis\u00e9s pour recevoir l&rsquo;une ou l&rsquo;autre m\u00e9thode de s\u00e9dation. <\/p>\n<p>L&rsquo;\u00e9tude a atteint son objectif principal, d\u00e9montrant la non-inf\u00e9riorit\u00e9 de Sedaconda par rapport au propofol intraveineux dans le maintien d&rsquo;une profondeur de s\u00e9dation ad\u00e9quate. En outre, les r\u00e9sultats ont montr\u00e9 que la s\u00e9dation par Sedaconda r\u00e9duisait le besoin d&rsquo;opio\u00efdes, facilitait la respiration spontan\u00e9e et permettait un r\u00e9veil plus rapide et plus pr\u00e9visible. En termes de s\u00e9curit\u00e9, Sedaconda a \u00e9t\u00e9 bien tol\u00e9r\u00e9, avec un profil de s\u00e9curit\u00e9 coh\u00e9rent avec les r\u00e9sultats pr\u00e9c\u00e9dents pour l&rsquo;isoflurane.  <\/p>\n<p>Les r\u00e9sultats ont \u00e9t\u00e9 publi\u00e9s dans la revue The Lancet Respiratory Medicine (Meiser et al., 2021) et ont servi de base \u00e0 l&rsquo;autorisation de mise sur le march\u00e9 europ\u00e9en de Sedana Medical pour Sedaconda dans le cadre de la s\u00e9dation par inhalation.<\/p>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Accueil Nos recherches Nous croyons au travail en partenariat dans nos projets de recherche, dans le but de poursuivre le d\u00e9veloppement et les avanc\u00e9es m\u00e9dicales au profit des patients en soins intensifs.Sedana Medical AB (publ) (\u00ab\u00a0Sedana Medical\u00a0\u00bb) est une soci\u00e9t\u00e9 pionni\u00e8re dans le domaine des technologies m\u00e9dicales et pharmaceutiques, sp\u00e9cialis\u00e9e dans la s\u00e9dation par inhalation [&hellip;]<\/p>\n","protected":false},"author":249802924,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column\" style=\"flex-basis:50%\">\r\n<h2 class=\"wp-block-heading\">About<\/h2>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column\" style=\"flex-basis:50%\">\r\n<p>Sedana Medical is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient\u2019s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical product Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.<\/p>\r\n\r\n\r\n\r\n<p>Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.<\/p>\r\n\r\n\r\n\r\n<p>Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm and is headquartered in Stockholm, Sweden.<\/p>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column\">\r\n<h3 class=\"wp-block-heading has-medium-font-size\">SEDANA MEDICAL IN NUMBERS<\/h3>\r\n\r\n\r\n\r\n<p>~100 No. of employees<\/p>\r\n\r\n\r\n\r\n<p>52\/48 % women\/men<\/p>\r\n\r\n\r\n\r\n<p>16 No. of nationalities employed<\/p>\r\n\r\n\r\n\r\n<p>159 Total sales 2021, MSEK<\/p>\r\n\r\n\r\n\r\n<p>>40 No. of countries where we have sales<\/p>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall.jpg\" alt=\"\" class=\"wp-image-13699\" style=\"aspect-ratio:3\/4;object-fit:cover\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column\">\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall-alt.jpg\" alt=\"\" class=\"wp-image-13707\" style=\"aspect-ratio:3\/4;object-fit:cover\" \/><\/figure>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall-alt.jpg\" alt=\"\" class=\"wp-image-13707\" style=\"aspect-ratio:4\/3;object-fit:cover\" \/><\/figure>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column is-vertically-aligned-center\">\r\n<h2 class=\"wp-block-heading has-text-align-center\">CERTIFICATES<\/h2>\r\n\r\n\r\n\r\n<p style=\"margin-right:var(--wp--preset--spacing--60);margin-left:var(--wp--preset--spacing--60)\">Sedana Medical\u2019s products are developed and manufactured in accordance with quality-controlled processes. The company has a quality management system that fulfils the requirements of ISO 13485 (design and manufacturing of medical devices) and holds MDSAP certificates for Canada and Japan.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons\">\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\">Certificate MDR 736312<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\">Certificate Of Registration MD 667829<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\">Certificate CE 667826<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\">Certificate MDSAP 706954<\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n","_et_gb_content_width":"","_wpcom_ai_launchpad_about_page":false,"_wpcom_ai_launchpad_gallery_page":false,"_wpcom_ai_launchpad_contact_page":false,"_wpcom_ai_launchpad_events_page":false,"_wpcom_ai_launchpad_video_page":false,"_wpcom_ai_launchpad_portfolio_piece":false,"footnotes":""},"dipi_cpt_category":[],"class_list":["post-5832","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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