{"id":69629,"date":"2026-07-08T15:07:59","date_gmt":"2026-07-08T07:07:59","guid":{"rendered":"https:\/\/flcube.com\/?p=69629"},"modified":"2026-07-08T15:08:00","modified_gmt":"2026-07-08T07:08:00","slug":"jenscares-lux-valve-plus-secures-ce-mark-as-worlds-second-transcatheter-tricuspid-valve-replacement","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69629","title":{"rendered":"Jenscare&#8217;s LuX-Valve Plus Secures CE Mark as World&#8217;s Second Transcatheter Tricuspid Valve Replacement"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jenscare Scientific Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/9877:HKG\">HKG: 9877<\/a>) announced that its proprietary <strong>transvenous tricuspid valve replacement system, LuX-Valve Plus<\/strong>, has received <strong>European Union Medical Device Regulation (MDR) CE certification<\/strong>. The device represents the <strong>world&#8217;s second approved transcatheter in-situ tricuspid valve replacement product<\/strong>, featuring innovative design elements that address key clinical challenges in tricuspid regurgitation treatment.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone-amp-product-classification\" class=\"wp-block-heading\">Regulatory Milestone &amp; Product Classification<\/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>Product<\/strong><\/td><td>LuX-Valve Plus transvenous tricuspid valve replacement system<\/td><\/tr><tr><td><strong>Regulatory Approval<\/strong><\/td><td>EU MDR CE Certification<\/td><\/tr><tr><td><strong>Classification<\/strong><\/td><td>World&#8217;s second transcatheter in-situ tricuspid valve replacement<\/td><\/tr><tr><td><strong>Approach<\/strong><\/td><td>Transvascular (minimally invasive)<\/td><\/tr><tr><td><strong>Size Range<\/strong><\/td><td>Seven sizes (40mm to 70mm)<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>8 July 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-technology-innovation-amp-clinical-advantages\" class=\"wp-block-heading\">Technology Innovation &amp; Clinical Advantages<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Interventricular Septum Anchoring<\/strong>: Unlike conventional prosthetic valves that rely on radial force for fixation, LuX-Valve Plus employs a <strong>septal anchoring design<\/strong> that minimizes cardiac tissue damage and facilitates <strong>post-operative right ventricular remodeling<\/strong>, potentially improving long-term cardiac function.<\/li>\n\n\n\n<li><strong>Reduced Pacemaker Risk<\/strong>: The non-radial force anchoring mechanism significantly <strong>reduces the risk of conduction disturbances<\/strong> requiring permanent pacemaker implantation\u2014a common complication with traditional transcatheter valve technologies.<\/li>\n\n\n\n<li><strong>Anti-Leak Technology<\/strong>: An <strong>adaptive anti-leak skirt<\/strong> effectively minimizes <strong>paravalvular leak<\/strong>, a critical factor in ensuring optimal hemodynamic performance and preventing recurrent tricuspid regurgitation.<\/li>\n\n\n\n<li><strong>Precision Delivery System<\/strong>: A <strong>multi-dimensionally steerable delivery catheter<\/strong> enables precise valve positioning during deployment, crucial for successful outcomes in the anatomically complex tricuspid valve environment.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tricuspid regurgitation affects approximately <strong>1.6 million patients in Europe<\/strong> and <strong>over 3 million globally<\/strong>, with severe cases carrying poor prognosis and limited treatment options beyond high-risk surgical intervention.<\/p>\n\n\n\n<h2 id=\"h-market-positioning-amp-competitive-landscape\" class=\"wp-block-heading\">Market Positioning &amp; Competitive Landscape<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Second-Mover Advantage<\/strong>: As the <strong>world&#8217;s second approved device<\/strong> in this emerging category, LuX-Valve Plus benefits from validated market demand while incorporating design improvements based on clinical experience with the first-generation technology.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Comprehensive Sizing<\/strong>: The availability of <strong>seven sizes (40-70mm)<\/strong> addresses the broad anatomical variability of tricuspid annuli, enabling treatment of a wider patient population compared to more limited sizing options in competing devices.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Minimally Invasive Approach<\/strong>: The <strong>transvascular delivery method<\/strong> eliminates the need for open-heart surgery or direct cardiac puncture, making the therapy accessible to high-risk and elderly patients who would otherwise be ineligible for surgical intervention.<\/p>\n\n\n\n<h2 id=\"h-commercial-strategy-amp-global-expansion\" class=\"wp-block-heading\">Commercial Strategy &amp; Global Expansion<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>EU Market Entry<\/strong>: CE certification enables immediate commercial launch across all 27 EU member states plus associated countries, representing the world&#8217;s largest integrated medical device market.<\/li>\n\n\n\n<li><strong>Reimbursement Pathway<\/strong>: The established precedent of the first approved device provides a clear pathway for hospital adoption and reimbursement coding, accelerating market penetration.<\/li>\n\n\n\n<li><strong>Pipeline Validation<\/strong>: Success with LuX-Valve Plus validates Jenscare&#8217;s structural heart platform and supports development of additional transcatheter valve technologies for other cardiac indications.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking information regarding regulatory approvals, market opportunities, and commercial strategies. Actual results may differ due to market adoption rates, competitive dynamics, reimbursement decisions, and clinical outcomes.<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\/07\/2026070800120_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026070800120_c.\"><\/object><a id=\"wp-block-file--media-0aef3165-3e68-4aa0-9f3a-f56b9993b807\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026070800120_c.pdf\">2026070800120_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026070800120_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0aef3165-3e68-4aa0-9f3a-f56b9993b807\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jenscare Scientific Co., Ltd. (HKG: 9877) announced that its proprietary transvenous tricuspid valve replacement system,&#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":[1300,583],"class_list":["post-69629","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-hkg-9877","tag-jenscare-scientific"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jenscare&#039;s LuX-Valve Plus Secures CE Mark as World&#039;s Second Transcatheter Tricuspid Valve Replacement - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that its proprietary transvenous tricuspid valve replacement system, LuX-Valve Plus, has received European Union Medical Device Regulation (MDR) CE certification. The device represents the world&#039;s second approved transcatheter in-situ tricuspid valve replacement product, featuring innovative design elements that address key clinical challenges in tricuspid regurgitation treatment.\" \/>\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=69629\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jenscare&#039;s LuX-Valve Plus Secures CE Mark as World&#039;s Second Transcatheter Tricuspid Valve Replacement\" \/>\n<meta property=\"og:description\" content=\"Jenscare Scientific Co., Ltd. (HKG: 9877) announced that its proprietary transvenous tricuspid valve replacement system, LuX-Valve Plus, has received European Union Medical Device Regulation (MDR) CE certification. 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