{"id":56678,"date":"2026-02-09T21:21:11","date_gmt":"2026-02-09T13:21:11","guid":{"rendered":"https:\/\/flcube.com\/?p=56678"},"modified":"2026-02-09T21:21:12","modified_gmt":"2026-02-09T13:21:12","slug":"jenscare-scientifics-lux-valve-plus-wins-fda-nod-for-us-pivotal-trial-in-tricuspid-regurgitation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56678","title":{"rendered":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation"},"content":{"rendered":"\n<p><strong>Jenscare Scientific Co., Ltd.<\/strong> (<strong><a href=\"https:\/\/www.google.com\/finance\/quote\/9877:HKG\">HKG: 9877<\/a><\/strong>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has granted <strong>Investigational Device Exemption (IDE)<\/strong> approval to initiate a <strong>pivotal regulatory study<\/strong> for its <strong>LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system<\/strong>. The Chinese\u2011developed device targets <strong>severe tricuspid regurgitation (TR) patients at high surgical risk<\/strong>, marking a critical step toward <strong>US market entry<\/strong> for the novel interventional cardiology platform.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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>Jenscare Scientific Co., Ltd. (HKG: 9877)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>U.S. Food and Drug Administration (FDA)<\/td><\/tr><tr><td><strong>Asset<\/strong><\/td><td>LuX-Valve Plus \u2013 Transcatheter tricuspid valve replacement (TTVR) system<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>IDE clearance for pivotal regulatory study<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Severe tricuspid regurgitation, high surgical risk<\/td><\/tr><tr><td><strong>Global Implant Record<\/strong><\/td><td>Multiple successful cases worldwide with demonstrated safety\/efficacy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-platform-amp-design-innovation\">Technology Platform &amp; Design Innovation<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Technical Specification<\/th><th>Clinical Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Anchoring Mechanism<\/strong><\/td><td><strong>Interventricular septal anchoring<\/strong><\/td><td>Eliminates need for radial force against fragile tricuspid annulus, reducing perforation risk<\/td><\/tr><tr><td><strong>Anti-Leak Design<\/strong><\/td><td><strong>Adaptive valve ring<\/strong><\/td><td>Conforms to irregular annular anatomy, minimizing paravalvular leak<\/td><\/tr><tr><td><strong>Delivery Approach<\/strong><\/td><td><strong>Transjugular venous access<\/strong><\/td><td>Avoids sternotomy and cardiopulmonary bypass; enables truly percutaneous procedure<\/td><\/tr><tr><td><strong>Size Range<\/strong><\/td><td><strong>Multiple valve sizes<\/strong><\/td><td>Accommodates diverse patient anatomies and right ventricular dimensions<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-target-indication-amp-market-opportunity\">Target Indication &amp; Market Opportunity<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Tricuspid Regurgitation Burden:<\/strong> Severe TR affects <strong>>1.6 million patients<\/strong> in the US alone, with <strong>&lt;1% receiving surgical intervention<\/strong> due to high operative mortality in elderly\/comorbid populations.<\/li>\n\n\n\n<li><strong>Structural Heart Gap:<\/strong> TTVR represents the <strong>final frontier of transcatheter valve therapy<\/strong>; while TAVR (aortic) and TMVR (mitral) are established, <strong>tricuspid solutions remain limited<\/strong>\u2014creating first-mover premium pricing potential.<\/li>\n\n\n\n<li><strong>LuX-Valve Plus Differentiation:<\/strong> Unlike <strong>Edwards EVOQUE<\/strong> (annular anchoring) and <strong>Abbott TriClip<\/strong> (leaflet repair), LuX-Valve Plus\u2019s <strong>septal anchoring<\/strong> addresses <strong>extreme right atrial dilation<\/strong> cases where traditional approaches fail.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning-amp-competitive-landscape\">Strategic Positioning &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Competitor<\/th><th>Product<\/th><th>Mechanism<\/th><th>LuX-Valve Plus Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Edwards Lifesciences<\/strong><\/td><td>EVOQUE<\/td><td>Annular\u2011anchored TTVR<\/td><td>Septal fixation for severely dilated annuli<\/td><\/tr><tr><td><strong>Abbott<\/strong><\/td><td>TriClip<\/td><td>Leaflet edge\u2011to\u2011edge repair<\/td><td>Replacement (not repair) for destroyed valves<\/td><\/tr><tr><td><strong>Medtronic<\/strong><\/td><td>Intrepid (investigational)<\/td><td>Transseptal mitral\u2011adapted<\/td><td>Purpose\u2011built tricuspid design vs. adapted mitral tech<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China\u2011to\u2011Global Expansion:<\/strong> FDA IDE approval validates Jenscare\u2019s <strong>US regulatory strategy<\/strong> and positions the company as <strong>first Chinese TTVR manufacturer<\/strong> to pursue US market authorization.<\/li>\n\n\n\n<li><strong>Hong Kong Listing Synergy:<\/strong> <strong>9877.HK<\/strong> listing provides <strong>USD capital access<\/strong> for US trial execution and potential US IPO pathway for commercial subsidiary.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-roadmap\">Development Roadmap<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Activity<\/th><th>Timeline<\/th><\/tr><\/thead><tbody><tr><td><strong>Current<\/strong><\/td><td>FDA IDE approval; US pivotal trial initiation<\/td><td>Q1 2026<\/td><\/tr><tr><td><strong>Near-term<\/strong><\/td><td>US pivotal enrollment (target: ~150-200 patients)<\/td><td>2026-2027<\/td><\/tr><tr><td><strong>Parallel<\/strong><\/td><td>CE Mark submission for European market<\/td><td>2026<\/td><\/tr><tr><td><strong>Future<\/strong><\/td><td>US PMA submission and potential approval<\/td><td>2028<\/td><\/tr><tr><td><strong>Global<\/strong><\/td><td>Expanded indications (functional TR, redo procedures)<\/td><td>Post-approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding LuX-Valve Plus US pivotal trial execution, FDA PMA pathway timelines, and Jenscare Scientific\u2019s global TTVR commercialization strategy. Actual results may differ due to trial enrollment challenges, competitive responses from Edwards and Abbott, and regulatory requirements for novel septal anchoring mechanisms.<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\/02\/2026020601219_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026020601219_c.\"><\/object><a id=\"wp-block-file--media-f598707f-e97f-4f5a-b291-d577653e8936\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/2026020601219_c.pdf\">2026020601219_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/2026020601219_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f598707f-e97f-4f5a-b291-d577653e8936\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":56680,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[62,1300,583],"class_list":["post-56678","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-clinical-trial-approval-initiation","tag-hkg-9877","tag-jenscare-scientific"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.\" \/>\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=56678\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation\" \/>\n<meta property=\"og:description\" content=\"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=56678\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-09T13:21:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-09T13:21:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter: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 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=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation\",\"datePublished\":\"2026-02-09T13:21:11+00:00\",\"dateModified\":\"2026-02-09T13:21:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678\"},\"wordCount\":489,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0904.webp\",\"keywords\":[\"Clinical trial approval \\\/ initiation\",\"HKG: 9877\",\"Jenscare Scientific\"],\"articleSection\":[\"Company\",\"Medical Device\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=56678#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=56678\",\"name\":\"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0904.webp\",\"datePublished\":\"2026-02-09T13:21:11+00:00\",\"dateModified\":\"2026-02-09T13:21:12+00:00\",\"description\":\"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=56678\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0904.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0904.webp\",\"width\":1080,\"height\":608,\"caption\":\"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56678#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation\"}]},{\"@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":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation - Insight, China&#039;s Pharmaceutical Industry","description":"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.","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=56678","og_locale":"en_US","og_type":"article","og_title":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation","og_description":"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.","og_url":"https:\/\/flcube.com\/?p=56678","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-02-09T13:21:11+00:00","article_modified_time":"2026-02-09T13:21:12+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_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","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=56678#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=56678"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation","datePublished":"2026-02-09T13:21:11+00:00","dateModified":"2026-02-09T13:21:12+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=56678"},"wordCount":489,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=56678#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","keywords":["Clinical trial approval \/ initiation","HKG: 9877","Jenscare Scientific"],"articleSection":["Company","Medical Device"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=56678#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=56678","url":"https:\/\/flcube.com\/?p=56678","name":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=56678#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=56678#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","datePublished":"2026-02-09T13:21:11+00:00","dateModified":"2026-02-09T13:21:12+00:00","description":"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a pivotal regulatory study for its LuX-Valve Plus transcatheter tricuspid valve replacement (TTVR) system. The Chinese\u2011developed device targets severe tricuspid regurgitation (TR) patients at high surgical risk, marking a critical step toward US market entry for the novel interventional cardiology platform.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=56678#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=56678"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=56678#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","width":1080,"height":608,"caption":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=56678#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Jenscare Scientific\u2019s LuX-Valve Plus Wins FDA Nod for US Pivotal Trial in Tricuspid Regurgitation"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0904.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56678","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=56678"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56678\/revisions"}],"predecessor-version":[{"id":56681,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56678\/revisions\/56681"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/56680"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56678"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56678"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56678"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}