{"id":10995,"date":"2023-12-01T01:20:00","date_gmt":"2023-11-30T17:20:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10995"},"modified":"2024-11-03T01:22:50","modified_gmt":"2024-11-02T17:22:50","slug":"acotec-secures-fda-ide-approval-for-acoart-litos-paclitaxel-coated-balloon-catheter","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10995","title":{"rendered":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter"},"content":{"rendered":"\n

Acotec Scientific Holdings Ltd (HKG: 6669<\/a>), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.<\/p>\n\n\n\n

The AcoArt Litos is designed to prevent below-the-knee (BTK) artery stenosis or occlusion and to treat chronic limb ischemia through vascular intervention. The device has previously secured CE marks, breakthrough device designation, and marketing approvals in the European Union, U.S., and China in 2014, 2019, and 2020, respectively, underscoring its established presence in the global market.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE)…<\/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_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[133,90,69,923],"class_list":["post-10995","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-acotec-scientific","tag-clinical-trial-filings","tag-cvd","tag-hkg-6669"],"yoast_head":"\nAcotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=10995\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=10995\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-11-30T17:20:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-02T17:22:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter\",\"datePublished\":\"2023-11-30T17:20:00+00:00\",\"dateModified\":\"2024-11-02T17:22:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995\"},\"wordCount\":117,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Acotec Scientific\",\"Clinical trial filings\",\"CVD\",\"HKG: 6669\"],\"articleSection\":[\"Company\",\"Medical Device\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=10995#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=10995\",\"name\":\"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-11-30T17:20:00+00:00\",\"dateModified\":\"2024-11-02T17:22:50+00:00\",\"description\":\"Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=10995\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10995#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter - Insight, China's Pharmaceutical Industry","description":"Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=10995","og_locale":"en_US","og_type":"article","og_title":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=10995","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-11-30T17:20:00+00:00","article_modified_time":"2024-11-02T17:22:50+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=10995#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=10995"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter","datePublished":"2023-11-30T17:20:00+00:00","dateModified":"2024-11-02T17:22:50+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=10995"},"wordCount":117,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Acotec Scientific","Clinical trial filings","CVD","HKG: 6669"],"articleSection":["Company","Medical Device"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=10995#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=10995","url":"https:\/\/flcube.com\/?p=10995","name":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-11-30T17:20:00+00:00","dateModified":"2024-11-02T17:22:50+00:00","description":"Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=10995#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=10995"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=10995#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/10995","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=10995"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/10995\/revisions"}],"predecessor-version":[{"id":10996,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/10995\/revisions\/10996"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=10995"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=10995"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=10995"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}