{"id":15660,"date":"2025-05-21T07:19:27","date_gmt":"2025-05-21T14:19:27","guid":{"rendered":"https:\/\/elixirmedical.com\/?p=15660"},"modified":"2025-05-21T07:39:51","modified_gmt":"2025-05-21T14:39:51","slug":"europcr-2025-late-breaking-data-demonstrate-sustained-significantly-lower-event-rates-with-elixir-medicals-dynamx-bioadaptor-over-drug-eluting-stent-through-three-years","status":"publish","type":"post","link":"https:\/\/elixirmedical.com\/id\/europcr-2025-late-breaking-data-demonstrate-sustained-significantly-lower-event-rates-with-elixir-medicals-dynamx-bioadaptor-over-drug-eluting-stent-through-three-years\/","title":{"rendered":"EuroPCR 2025: Late-Breaking Data Demonstrate Sustained Significantly Lower Event Rates With Elixir Medical\u2019s DynamX\u00ae Bioadaptor Over Drug-Eluting Stent Through Three Years"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"15660\" class=\"elementor elementor-15660\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-42dd510a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42dd510a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4e86aaec\" data-id=\"4e86aaec\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7b9b726 elementor-widget elementor-widget-heading\" data-id=\"7b9b726\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX\u00ae compared to DES<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e02624 elementor-widget elementor-widget-heading\" data-id=\"3e02624\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX\u00ae compared to DES<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc93971 elementor-widget elementor-widget-text-editor\" data-id=\"bc93971\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Paris \u2013 May 21, 2025 \u2013 <\/strong><a href=\"http:\/\/elixirmedical.com\">Elixir Medical<\/a>, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX<sup>\u00ae<\/sup> Coronary Bioadaptor System to standard of care Resolute Onyx<sup>TM<\/sup> Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX&nbsp;bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris.<\/p>\n<p><strong>Clinical results show sustained significant reduction of device-oriented adverse events with DynamX&nbsp;bioadaptor over the drug-eluting stent at three years:<\/strong><\/p>\n<ul>\n<li>Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX&nbsp;treatment through 3 years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX&nbsp;compared to DES, respectively:\n<ul>\n<li>Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033)<\/li>\n<li>Target Vessel Myocardial Infarction (0.9% versus 1.8%)<\/li>\n<li>Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong><br><\/strong><\/p><p><strong>Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions:<\/strong><\/p>\n<ul>\n<li>Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months<sup>1<\/sup>.<\/li>\n<\/ul>\n<p>\u201cThese three-year results from the BIOADAPTOR RCT demonstrate that DynamX<span style=\"font-size: 1rem;\">&nbsp;bioadaptor provides for a new class of treatment \u2014 with significant clinical benefit from 6 months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,\u201d said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. \u201cWe also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.\u201d<\/span><\/p>\n<p>The DynamX<span style=\"font-size: 12px; line-height: 0; position: relative; vertical-align: baseline; top: -0.5em;\">&nbsp;<\/span>bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after 6 months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion.<\/p>\n<p>\u201cWith these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,\u201d said Motasim Sirhan, CEO of Elixir Medical. \u201cWith the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in <em>The Lancet<\/em>, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX&nbsp;bioadaptor compared to DES, validating the benefit of our transformative technology.\u201d<\/p>\n<p><strong>About BIOADAPTOR RCT Trial<\/strong><\/p>\n<p>The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years.<\/p>\n<p>BIOADAPTOR RCT trial is the third trial of Elixir Medical\u2019s robust DynamX&nbsp;bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients.<\/p>\n<p><strong>About&nbsp;<\/strong><span style=\"font-weight: bolder;\">DynamX&nbsp;<\/span><strong>Coronary Bioadaptor System<\/strong><\/p>\n<p>The DynamX&nbsp;bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up.<\/p>\n<p>The DynamX&nbsp;Coronary Bioadaptor System is CE-marked. The DynamX&nbsp;Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use.<\/p>\n<p><strong>About Elixir Medical<\/strong><\/p>\n<p>Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company\u2019s prestigious list of the World\u2019s Most Innovative Companies of 2025. Visit us at <a href=\"http:\/\/www.elixirmedical.com\">www.elixirmedical.com<\/a> and on <a href=\"https:\/\/www.linkedin.com\/company\/elixir-medical-corporation\/\">LinkedIn<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f5322e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2f5322e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dc6cce elementor-widget elementor-widget-text-editor\" data-id=\"2dc6cce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Media Contact:<br \/><\/strong>Richard Laermer<br \/>RLM PR<br \/><a href=\"mailto:elixir@rlmpr.com\">elixir@rlmpr.com<\/a><br \/>(212) 741-5106 X 216<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-58eae5d elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"58eae5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Late-breaking data demonstrate sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) and significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX\u00ae compared to DES.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46],"tags":[],"class_list":["post-15660","post","type-post","status-publish","format-standard","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lower Event Rates with DynamX Compared to DES | Elixir Medical<\/title>\n<meta name=\"description\" content=\"Late-breaking data demonstrate sustained significantly lower event rates with Elixir&#039;s DynamX\u00ae bioadaptor over DES through three years.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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