{"id":72192,"date":"2026-08-10T13:45:45","date_gmt":"2026-08-10T05:45:45","guid":{"rendered":"https:\/\/flcube.com\/?p=72192"},"modified":"2026-08-10T13:45:45","modified_gmt":"2026-08-10T05:45:45","slug":"sino-medical-sciences-neurovita-wins-eu-mdr-ce-certification-for-cometiu-worlds-first-intracranial-drug-eluting-stent-system","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72192","title":{"rendered":"Sino Medical Sciences&#8217; Neurovita Wins EU MDR CE Certification for COMETIU, World&#8217;s First Intracranial Drug\u2011Eluting Stent System"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Sino Medical Sciences Technology Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/688108:SHA\">SHA: 688108<\/a>) announced that the <strong>COMETIU self\u2011expanding intracranial drug\u2011eluting stent system<\/strong>, independently developed by its subsidiary <strong>Neurovita<\/strong>, has obtained <strong>EU CE certification<\/strong> under the <strong>Medical Device Regulation (MDR)<\/strong>. The certification clears the European market for what the company describes as the <strong>world&#8217;s first nitinol self\u2011expanding drug\u2011eluting stent system specifically designed for intracranial atherosclerotic stenosis<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Sino Medical Sciences Technology Inc. (SHA: 688108), via subsidiary Neurovita<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>COMETIU self\u2011expanding intracranial drug\u2011eluting stent system<\/td><\/tr><tr><td><strong>Certification<\/strong><\/td><td>EU CE certification under Medical Device Regulation (MDR)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Intracranial atherosclerotic stenosis<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>10 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-device-profile-amp-design\" class=\"wp-block-heading\">Device Profile &amp; Design<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011in\u2011Class:<\/strong> The <strong>world&#8217;s first nitinol self\u2011expanding drug\u2011eluting stent system<\/strong> specifically designed for <strong>intracranial atherosclerotic stenosis<\/strong><\/li>\n\n\n\n<li><strong>Stent Architecture:<\/strong> <strong>Closed\u2011cell asymmetric polygonal mesh design<\/strong><\/li>\n\n\n\n<li><strong>Drug Coating Structure:<\/strong><\/li>\n\n\n\n<li>Base layer: <strong>poly (butyl methacrylate) (PBuMA)<\/strong><\/li>\n\n\n\n<li>Drug layer: <strong>biodegradable polymer layer (PLGA)<\/strong> containing <strong>sirolimus<\/strong><\/li>\n\n\n\n<li><strong>Coating Technology:<\/strong> Combines <strong>electrografting coating technology<\/strong> with <strong>controlled\u2011release drug loading<\/strong> to enable targeted drug release<\/li>\n\n\n\n<li><strong>Dual Benefit:<\/strong> Balances <strong>optimal self\u2011expansion and wall apposition<\/strong> after microcatheter delivery with <strong>effective inhibition of vascular in\u2011stent restenosis<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Gateway:<\/strong> EU MDR CE certification \u2014 one of the most demanding pathways for medical devices \u2014 positions COMETIU for commercialization across the European market through Sino Medical Sciences&#8217; international channels.<\/li>\n\n\n\n<li><strong>Unmet Clinical Need:<\/strong> Intracranial atherosclerotic stenosis carries high stroke risk and limited treatment options; a device purpose\u2011built for intracranial anatomy, rather than adapted from coronary platforms, addresses a distinct clinical segment.<\/li>\n\n\n\n<li><strong>Restenosis Solution:<\/strong> By pairing self\u2011expansion mechanics with sirolimus\u2011based controlled drug release, COMETIU targets in\u2011stent restenosis \u2014 a key failure mode in intracranial stenting \u2014 while preserving deliverability through microcatheter navigation of tortuous cerebral vasculature.<\/li>\n\n\n\n<li><strong>Category Leadership:<\/strong> As the first nitinol self\u2011expanding drug\u2011eluting stent of its kind to reach CE certification, Neurovita&#8217;s device establishes a reference point in a nascent category of intracranial drug\u2011eluting implants.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the commercialization of the COMETIU intracranial drug\u2011eluting stent system in Europe. Actual results may differ due to risks including market adoption, competitive dynamics, and regulatory developments.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688108_20260810_88OR.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688108_20260810_88OR.\"><\/object><a id=\"wp-block-file--media-fe79fd70-4452-48a7-ac3a-b21ac35ae7c4\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688108_20260810_88OR.pdf\">688108_20260810_88OR<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688108_20260810_88OR.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-fe79fd70-4452-48a7-ac3a-b21ac35ae7c4\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino Medical Sciences Technology Inc. (SHA: 688108) announced that the COMETIU self\u2011expanding intracranial drug\u2011eluting stent&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,22],"tags":[15,1054,298],"class_list":["post-72192","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-product-approvals","tag-sha-688108","tag-sino-medical-sciences-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sino Medical Sciences&#039; Neurovita Wins EU MDR CE Certification for COMETIU, World&#039;s First Intracranial Drug\u2011Eluting Stent System - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino Medical Sciences Technology Inc. (SHA: 688108) announced that the COMETIU self\u2011expanding intracranial drug\u2011eluting stent system, independently developed by its subsidiary Neurovita, has obtained EU CE certification under the Medical Device Regulation (MDR). 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(SHA: 688108) announced that the COMETIU self\u2011expanding intracranial drug\u2011eluting stent system, independently developed by its subsidiary Neurovita, has obtained EU CE certification under the Medical Device Regulation (MDR). 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