{"id":54868,"date":"2026-01-20T20:10:57","date_gmt":"2026-01-20T12:10:57","guid":{"rendered":"https:\/\/flcube.com\/?p=54868"},"modified":"2026-01-20T20:10:59","modified_gmt":"2026-01-20T12:10:59","slug":"blue-sails-lithonic-ivl-system-wins-ce-mark-for-coronary-calcified-lesions","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54868","title":{"rendered":"Blue Sail\u2019s Lithonic IVL System Wins CE Mark for Coronary Calcified Lesions"},"content":{"rendered":"\n<p><strong>Blue Sail Medical Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002382:SHE\">SHE: 002382<\/a>) announced that its <strong>Lithonic coronary intravascular shockwave therapy system<\/strong> has received <strong>CE qualification<\/strong> in the <strong>European Union (EU)<\/strong>, clearing the device for commercialization across member states. The system was developed by Blue Sail\u2019s cardiovascular subsidiary, <strong>Biosensors Interventional Technologies Pte. Ltd<\/strong>.<\/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>Blue Sail Medical Co., Ltd (002382.SZ)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Lithonic coronary intravascular shockwave therapy system<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Biosensors Interventional Technologies Pte. Ltd (subsidiary)<\/td><\/tr><tr><td><strong>Certification<\/strong><\/td><td>CE Mark (European Union)<\/td><\/tr><tr><td>**Indication<\/td><td>Intravascular lithotripsy (IVL) for severely calcified stenotic lesions<\/td><\/tr><tr><td>**Approval Date<\/td><td>14\u202fJan\u202f2026<\/td><\/tr><tr><td>**Technology<\/td><td>Electrohydraulic shockwave generation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-device-profile-amp-mechanism\">Device Profile &amp; Mechanism<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Principle:<\/strong> <strong>Intravascular lithotripsy (IVL)<\/strong> delivers <strong>high\u2011pressure acoustic waves<\/strong> to severely calcified coronary lesions<\/li>\n\n\n\n<li><strong>Mechanism of Action:<\/strong><\/li>\n\n\n\n<li><strong>Electrohydraulic effect:<\/strong> Electrodes generate shockwaves in an electrolyte solution<\/li>\n\n\n\n<li><strong>Shockwave propagation:<\/strong> Pressure waves precisely released within the vessel to <strong>modify calcified plaques<\/strong><\/li>\n\n\n\n<li><strong>Clinical Advantage:<\/strong> Enables <strong>stent expansion<\/strong> in lesions resistant to conventional balloon angioplasty<\/li>\n\n\n\n<li><strong>Safety Benefits:<\/strong> Reduces risks of <strong>vessel perforation<\/strong> and <strong>no\u2011reflow complications<\/strong> vs. rotational atherectomy<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-competitive-landscape\">Market Impact &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>EU Market<\/th><th>Global Market<\/th><\/tr><\/thead><tbody><tr><td><strong>Calcified Coronary Lesions (Annual)<\/strong><\/td><td>280,000<\/td><td>1.4\u202fmillion<\/td><\/tr><tr><td><strong>IVL\u2011Eligible Cases<\/strong><\/td><td>95,000<\/td><td>480,000<\/td><\/tr><tr><td><strong>Current IVL Penetration<\/strong><\/td><td>18%<\/td><td>12%<\/td><\/tr><tr><td><strong>IVL Market Value (2030E)<\/strong><\/td><td>\u20ac450\u202fmillion<\/td><td>$2.1\u202fbillion<\/td><\/tr><tr><td><strong>Lithonic Peak Share<\/strong><\/td><td>8%<\/td><td>5%<\/td><\/tr><tr><td><strong>Peak Revenue (2032E)<\/strong><\/td><td>\u20ac36\u202fmillion<\/td><td>$105\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Competitors:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Shockwave Medical<\/strong> \u2013 <strong>IVL market leader<\/strong> with <strong>Shockwave C2<\/strong> (70% share)<\/li>\n\n\n\n<li><strong>Fastwave Medical<\/strong> \u2013 Magnum IVL system (in development)<\/li>\n\n\n\n<li><strong>Lithonic<\/strong> \u2013 <strong>First Chinese\u2011developed IVL system<\/strong> with CE mark; <strong>competitive pricing advantage<\/strong> (20\u201130% below Shockwave)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Manufacturing:<\/strong> Blue Sail\u2019s <strong>Suzhou facility<\/strong> (ISO\u202f13485 certified) will produce Lithonic for EU markets; <strong>FDA IDE application<\/strong> planned for <strong>Q3\u202f2026<\/strong><\/li>\n\n\n\n<li><strong>Commercial Launch:<\/strong> EU rollout targeted for <strong>Q2\u202f2026<\/strong> through <strong>Biosensors\u2019 distribution network<\/strong> (covers 15 EU countries)<\/li>\n\n\n\n<li><strong>Reimbursement Strategy:<\/strong> CE mark enables <strong>national reimbursement pathways<\/strong>; seeking <strong>NUB innovation status<\/strong> in Germany for premium pricing<\/li>\n\n\n\n<li><strong>Pipeline Extension:<\/strong> Lithonic platform being adapted for <strong>peripheral artery disease (PAD)<\/strong> and <strong>renal denervation<\/strong> indications<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding CE certification benefits, market penetration, and revenue forecasts for Lithonic. Actual results may differ due to competitive responses, pricing pressures, and regulatory challenges in non\u2011EU markets.<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\/01\/\u84dd\u5e06\u533b\u7597\uff1a\u5173\u4e8e\u5b50\u516c\u53f8Lithonic\u51a0\u8109\u8840\u7ba1\u5185\u51b2\u51fb\u6ce2\u6cbb\u7597\u7cfb\u7edf\u83b7\u5f97CE\u8bc1\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u84dd\u5e06\u533b\u7597\uff1a\u5173\u4e8e\u5b50\u516c\u53f8Lithonic\u51a0\u8109\u8840\u7ba1\u5185\u51b2\u51fb\u6ce2\u6cbb\u7597\u7cfb\u7edf\u83b7\u5f97CE\u8bc1\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-879a24a4-a5c9-4f63-98bf-72f8aef57dd8\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u84dd\u5e06\u533b\u7597\uff1a\u5173\u4e8e\u5b50\u516c\u53f8Lithonic\u51a0\u8109\u8840\u7ba1\u5185\u51b2\u51fb\u6ce2\u6cbb\u7597\u7cfb\u7edf\u83b7\u5f97CE\u8bc1\u4e66\u7684\u516c\u544a.pdf\">\u84dd\u5e06\u533b\u7597\uff1a\u5173\u4e8e\u5b50\u516c\u53f8Lithonic\u51a0\u8109\u8840\u7ba1\u5185\u51b2\u51fb\u6ce2\u6cbb\u7597\u7cfb\u7edf\u83b7\u5f97CE\u8bc1\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u84dd\u5e06\u533b\u7597\uff1a\u5173\u4e8e\u5b50\u516c\u53f8Lithonic\u51a0\u8109\u8840\u7ba1\u5185\u51b2\u51fb\u6ce2\u6cbb\u7597\u7cfb\u7edf\u83b7\u5f97CE\u8bc1\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-879a24a4-a5c9-4f63-98bf-72f8aef57dd8\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Blue Sail Medical Co., Ltd (SHE: 002382) announced that its Lithonic coronary intravascular shockwave therapy&#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_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":[567,69,15,1280],"class_list":["post-54868","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-blue-sail-medical","tag-cvd","tag-product-approvals","tag-she-002382"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Blue Sail\u2019s Lithonic IVL System Wins CE Mark for Coronary Calcified Lesions - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Blue Sail Medical Co., Ltd (SHE: 002382) announced that its Lithonic coronary intravascular shockwave therapy system has received CE qualification in the European Union (EU), clearing the device for commercialization across member states. 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