{"id":74955,"date":"2026-08-17T12:38:51","date_gmt":"2026-08-17T04:38:51","guid":{"rendered":"https:\/\/flcube.com\/?p=74955"},"modified":"2026-08-17T12:38:54","modified_gmt":"2026-08-17T04:38:54","slug":"sino-medical-sciences-wins-turkish-approval-for-ghunter-intracranial-thrombectomy-stent-broadening-global-footprint-in-ischemic-stroke-care","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=74955","title":{"rendered":"Sino Medical Sciences Wins Turkish Approval for Ghunter Intracranial Thrombectomy Stent \u2013 Broadening Global Footprint in Ischemic Stroke Care"},"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 its independently developed <strong>Ghunter Revascularization Device<\/strong>, an <strong>intracranial thrombectomy stent<\/strong>, has received regulatory approval from the <strong>Turkish Ministry of Health<\/strong>. The clearance extends the device&#8217;s international regulatory track record following prior approvals in China and the European Union.<\/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>Agency<\/strong><\/td><td>Turkish Ministry of Health<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Regulatory approval for market authorization<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Ghunter Revascularization Device (intracranial thrombectomy stent)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Removal of intracranial large\u2011vessel blood clots in ischemic stroke within 24 hours of symptom onset<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>17 Aug 2026<\/td><\/tr><tr><td><strong>Prior Clearances<\/strong><\/td><td>China NMPA registration (Apr 2023); EU CE MDR certification (Feb 2026)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-device-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Device Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Device:<\/strong> <strong>Ghunter Revascularization Device<\/strong>, a stent\u2011based thrombectomy system designed for mechanical retrieval of intracranial thrombi<\/li>\n\n\n\n<li><strong>Target Vessels:<\/strong> Intracranial large vessels, including the <strong>internal carotid artery<\/strong>, <strong>M1 and M2 segments of the middle cerebral artery<\/strong>, <strong>basilar artery<\/strong>, and <strong>vertebral artery<\/strong><\/li>\n\n\n\n<li><strong>Treatment Window:<\/strong> Indicated within <strong>24 hours of symptom onset<\/strong>, restoring cerebral blood flow in eligible ischemic stroke patients<\/li>\n\n\n\n<li><strong>Patient Population:<\/strong> Candidates include patients who are <strong>ineligible for or have failed intravenous tissue plasminogen activator (IV t\u2011PA)<\/strong> therapy<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Independently developed by <strong>Sino Medical Sciences Technology<\/strong>, supporting the company&#8217;s proprietary neurovascular portfolio<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-global-regulatory-track-record\" class=\"wp-block-heading\">Global Regulatory Track Record<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Jurisdiction<\/th><th>Regulatory Body<\/th><th>Status<\/th><th>Date<\/th><\/tr><\/thead><tbody><tr><td><strong>China<\/strong><\/td><td>NMPA<\/td><td>Registration certificate granted<\/td><td>Apr 2023<\/td><\/tr><tr><td><strong>European Union<\/strong><\/td><td>CE MDR<\/td><td>Certification obtained<\/td><td>Feb 2026<\/td><\/tr><tr><td><strong>Turkey<\/strong><\/td><td>Ministry of Health<\/td><td>Regulatory approval obtained<\/td><td>Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The Turkish approval makes the <strong>Ghunter<\/strong> device one of the company&#8217;s neurovascular products cleared across three major regulatory jurisdictions, providing a foundation for further international commercialization.<\/p>\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>Stroke Landscape:<\/strong> Ischemic stroke caused by large\u2011vessel occlusion remains a leading cause of death and disability globally; mechanical thrombectomy has become the standard of care for eligible patients, with extended treatment windows broadening the treatable population.<\/li>\n\n\n\n<li><strong>Differentiated Positioning:<\/strong> A stent retriever indicated across multiple intracranial vessels \u2014 including posterior circulation territories such as the basilar and vertebral arteries \u2014 with a 24\u2011hour window addresses a broad clinical need, particularly for patients excluded from IV t\u2011PA therapy.<\/li>\n\n\n\n<li><strong>International Expansion Strategy:<\/strong> The sequence of NMPA, CE MDR and Turkish approvals signals a deliberate multi\u2011market rollout, with Turkey serving as a strategic bridge between European and Middle Eastern neurovascular markets.<\/li>\n\n\n\n<li><strong>Portfolio Momentum:<\/strong> The clearance strengthens <strong>Sino Medical Sciences&#8217;<\/strong> position in the fast\u2011growing neurointerventional device segment, where demand for locally developed, cost\u2011competitive alternatives continues to rise.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding market opportunity, commercialization plans, and international expansion for the Ghunter Revascularization Device. Actual results may differ due to risks including market adoption, reimbursement dynamics, and competitive developments in the neurovascular device market.<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_20260815_8V90.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688108_20260815_8V90.\"><\/object><a id=\"wp-block-file--media-8dae717e-75be-4fa4-b0af-79d7efacddc8\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688108_20260815_8V90.pdf\">688108_20260815_8V90<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688108_20260815_8V90.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-8dae717e-75be-4fa4-b0af-79d7efacddc8\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino Medical Sciences Technology Inc. (SHA: 688108) announced that its independently developed Ghunter Revascularization Device,&#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-74955","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 Wins Turkish Approval for Ghunter Intracranial Thrombectomy Stent \u2013 Broadening Global Footprint in Ischemic Stroke Care - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino Medical Sciences Technology Inc. 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