{"id":62026,"date":"2026-03-31T20:35:27","date_gmt":"2026-03-31T12:35:27","guid":{"rendered":"https:\/\/flcube.com\/?p=62026"},"modified":"2026-03-31T20:35:29","modified_gmt":"2026-03-31T12:35:29","slug":"boston-scientific-secures-fda-510k-clearance-for-asurys-fluid-management-system-in-kidney-stone-procedures","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=62026","title":{"rendered":"Boston Scientific Secures FDA 510(k) Clearance for Asurys Fluid Management System in Kidney Stone Procedures"},"content":{"rendered":"\n<p><strong>Boston Scientific<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/BSX:NYSE\">NYSE: BSX<\/a>) has announced <strong>FDA 510(k) clearance<\/strong> for its <strong>Asurys Fluid Management System<\/strong>, a specialized device designed to provide <strong>irrigation and distension<\/strong> for endoscopic urology procedures, including <strong>ureteroscopy<\/strong>. The system integrates with Boston Scientific&#8217;s <strong>StoneSmart solutions ecosystem<\/strong> and pairs with the <strong>LithoVue Elite single-use digital flexible ureteroscope<\/strong> to enhance intrarenal pressure (IRP) management during kidney stone treatments.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-approval-summary\">Regulatory Approval Summary<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Boston Scientific (NYSE: BSX)<\/td><\/tr><tr><td><strong>Device<\/strong><\/td><td>Asurys Fluid Management System<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>FDA 510(k) cleared<\/td><\/tr><tr><td><strong>Primary Indication<\/strong><\/td><td>Irrigation and distension for endoscopic urology procedures<\/td><\/tr><tr><td><strong>Key Procedure<\/strong><\/td><td>Ureteroscopy for kidney stone management<\/td><\/tr><tr><td><strong>Integration Platform<\/strong><\/td><td>StoneSmart solutions ecosystem<\/td><\/tr><tr><td><strong>Companion Device<\/strong><\/td><td>LithoVue Elite single-use digital flexible ureteroscope<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technical-specifications-amp-innovation\">Technical Specifications &amp; Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Fluid Management:<\/strong> Provides controlled irrigation and distension during endoscopic urology procedures<\/li>\n\n\n\n<li><strong>IRP Monitoring Integration:<\/strong> Designed to work with LithoVue Elite&#8217;s intrarenal pressure (IRP) monitoring capabilities<\/li>\n\n\n\n<li><strong>Pressure Management:<\/strong> Assists clinicians with real-time IRP management to maintain safe pressure levels during procedures<\/li>\n\n\n\n<li><strong>Ecosystem Approach:<\/strong> Latest addition to Boston Scientific&#8217;s comprehensive StoneSmart kidney stone treatment platform<\/li>\n\n\n\n<li><strong>Single-Use Compatibility:<\/strong> Optimized for use with disposable ureteroscopes, reducing cross-contamination risks<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-amp-operational-benefits\">Clinical &amp; Operational Benefits<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Stakeholder<\/th><th>Benefit<\/th><\/tr><\/thead><tbody><tr><td><strong>Urologists<\/strong><\/td><td>Enhanced control over intrarenal pressure during stone procedures, improving patient safety<\/td><\/tr><tr><td><strong>Hospitals\/ASCs<\/strong><\/td><td>Streamlined workflow through integrated StoneSmart ecosystem devices<\/td><\/tr><tr><td><strong>Patients<\/strong><\/td><td>Reduced procedural complications through better pressure management and single-use technology<\/td><\/tr><tr><td><strong>Healthcare Systems<\/strong><\/td><td>Potential cost savings from reduced procedure times and complication rates<\/td><\/tr><tr><td><strong>Infection Control<\/strong><\/td><td>Single-use ureteroscope eliminates reprocessing requirements and associated risks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The integration of fluid management with real-time pressure monitoring addresses a critical safety concern in ureteroscopy, where elevated intrarenal pressure can lead to serious complications including sepsis and renal damage.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-analysis\">Market Impact Analysis<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Strategic Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>Kidney Stone Prevalence<\/strong><\/td><td>Affects 1 in 11 Americans; incidence increasing due to dietary and lifestyle factors<\/td><\/tr><tr><td><strong>Ureteroscopy Volume<\/strong><\/td><td>Over 1 million procedures performed annually in the US alone<\/td><\/tr><tr><td><strong>Competitive Differentiation<\/strong><\/td><td>Integrated IRP management represents significant advancement over standalone fluid systems<\/td><\/tr><tr><td><strong>Ecosystem Lock-in<\/strong><\/td><td>Strengthens Boston Scientific&#8217;s position in comprehensive stone management solutions<\/td><\/tr><tr><td><strong>Reimbursement Environment<\/strong><\/td><td>Single-use ureteroscopes increasingly favored by payers due to infection control benefits<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The global kidney stone management market is projected to exceed USD 3 billion by 2028, driven by rising prevalence and technological adoption.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-outlook\">Strategic Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Commercial Launch:<\/strong> Immediate availability in US market following FDA clearance<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> 510(k) clearance provides foundation for international regulatory submissions<\/li>\n\n\n\n<li><strong>Platform Enhancement:<\/strong> Strengthens StoneSmart ecosystem&#8217;s competitive position against standalone device competitors<\/li>\n\n\n\n<li><strong>Revenue Contribution:<\/strong> Expected to contribute meaningfully to Boston Scientific&#8217;s Endoscopy segment growth<\/li>\n\n\n\n<li><strong>Clinical Adoption:<\/strong> Integration benefits likely to drive rapid adoption among high-volume stone centers<\/li>\n<\/ul>\n\n\n\n<p>The Asurys system represents Boston Scientific&#8217;s continued investment in comprehensive, integrated solutions for complex urological procedures, leveraging the company&#8217;s leadership in both endoscopy and stone management technologies.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding Boston Scientific&#8217;s product commercialization and market expectations. Actual commercial performance may vary based on market adoption, competitive dynamics, and regulatory developments.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Boston Scientific (NYSE: BSX) has announced FDA 510(k) clearance for its Asurys Fluid Management System,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":62028,"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":[315,1160,15],"class_list":["post-62026","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-boston-scientific","tag-nyse-bsx","tag-product-approvals"],"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>Boston Scientific Secures FDA 510(k) Clearance for Asurys Fluid Management System in Kidney Stone Procedures - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Boston Scientific (NYSE: BSX) has announced FDA 510(k) clearance for its Asurys Fluid Management System, a specialized device designed to provide irrigation and distension for endoscopic urology procedures, including ureteroscopy. 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