{"id":1015930,"date":"2026-11-01T15:02:35","date_gmt":"2026-11-01T20:02:35","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/"},"modified":"2026-11-01T15:02:35","modified_gmt":"2026-11-01T20:02:35","slug":"anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/","title":{"rendered":"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">MINNEAPOLIS and BRISBANE, Australia, Nov.  01, 2026  (GLOBE NEWSWIRE) &#8212; <strong>Anteris Technologies Global Corp. <\/strong>(\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR<sup>\u00ae<\/sup> Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 \u00b1 38 mm<sup>2<\/sup>). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch<sup>*<\/sup> (PPM) in a cohort of medium annuli patients from the EMBARK Study.<\/p>\n<p align=\"justify\">The 30-day Medium-size DurAVR THV results were presented by Azeem Latib, MD during the <em>Emerging Concepts and Innovations in TAVR <\/em>session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California.<\/p>\n<p align=\"justify\">\n        <strong>30-day Results Highlights <\/strong>\n      <\/p>\n<ul>\n<li style=\"text-align:justify\">DurAVR\u00a0THV delivered a favorable hemodynamic profile with a large EOA of 2.64\u00a0\u00b1\u00a00.19 cm<sup>2<\/sup> (baseline 0.8 \u00b1\u00a00.2 cm<sup>2<\/sup>) and a single digit mean pressure gradient (MPG) of 6.17 \u00b1 1.40 mmHg (baseline 45.5 \u00b1\u00a011.7 mmHg).\u00a0<\/li>\n<li style=\"text-align:justify\">At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).<\/li>\n<li>No moderate or severe prosthesis\u2013patient mismatch was observed at 30 days.<\/li>\n<\/ul>\n<p align=\"justify\">\u201cThese are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak. That matters because prosthesis-patient mismatch is not just a small-annulus problem. A recent study in younger, lower-risk TAVR patients found PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.\u00b9 As TAVR moves to patients who will live with their valve for decades, this is the hemodynamic profile we designed DurAVR to deliver, and we look forward to PARADIGM confirming it in a randomized setting,\u201d said Chris Meduri, M.D., Anteris Chief Medical Officer.<\/p>\n<p>The DurAVR THV is being evaluated in the ongoing global PARADIGM pivotal trial (ClinicalTrials.gov ID NCT07194265), which is actively enrolling patients and will include use of the Medium-size DurAVR THV. This prospective, randomized controlled trial (RCT) is designed to evaluate the safety and effectiveness of DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis.<\/p>\n<p align=\"justify\">\n        <sup>\u00b9Suruga K, et al. Prosthesis-Patient Mismatch in Young and Low-Risk Patients After Newer Generation Balloon-Expandable Transcatheter Aortic Valve Replacement.\u00a0<\/sup><br \/>\n        <sup><br \/>\n          <em>JACC Cardiovasc <\/em><br \/>\n        <\/sup><br \/>\n        <sup><br \/>\n          <em>Interv<\/em><br \/>\n        <\/sup><br \/>\n        <sup><br \/>\n          <em>.<\/em><br \/>\n        <\/sup><br \/>\n        <sup>\u00a02025;18(12).<\/sup>\n      <\/p>\n<p align=\"justify\">\n        <sup>*Prosthesis<\/sup><br \/>\n        <sup>\u2010<\/sup><br \/>\n        <sup>patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn&#8217;t have a large enough opening (EOA) to accommodate the patient&#8217;s blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve <\/sup><br \/>\n        <sup>(TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR).<\/sup>\n      <\/p>\n<p align=\"justify\">\n        <sup>**As defined in VARC-3<\/sup>\n      <\/p>\n<p align=\"justify\">\n        <strong>About the PARADIGM Trial<\/strong>\n      <\/p>\n<p align=\"justify\">The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs).<\/p>\n<p align=\"justify\">This head-to-head study will enrol approximately 1,000 patients in the \u2018All Comers Randomized Cohort&#8217; with 1:1 randomization of patients who will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.<\/p>\n<p align=\"justify\">For further information, please refer to ClinicalTrials.gov NCT07194265.<\/p>\n<p align=\"justify\">\n        <strong>About Anteris<\/strong>\n      <\/p>\n<p align=\"justify\">Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.<\/p>\n<p align=\"justify\">Anteris\u2019 lead product, the DurAVR THV, was designed in collaboration with the world\u2019s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis \u2013 a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT<sup>\u00ae<\/sup> tissue, Anteris\u2019 patented anti-calcification tissue technology. ADAPT tissue, which is FDA-cleared, has been used clinically for over 10\u00a0years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR<sup>\u00ae<\/sup> Delivery System.<\/p>\n<p align=\"justify\">DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION\u2014Investigational device. Limited by Federal (or United States) law to investigational use.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words \u201cbelieve,\u201d \u201cproject,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cbudget,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cstrategy,\u201d \u201cplan,\u201d \u201cguidance,\u201d \u201coutlook,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cwill be,\u201d \u201cwill continue,\u201d \u201cwill likely result\u201d and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under \u201cRisk Factors\u201d in Anteris\u2019 Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.\u00a0 \u00a0<\/p>\n<table style=\"border-collapse: collapse;width:99%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\n            <strong>For more information:<\/p>\n<p><\/strong>\n          <\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\n            <strong>Global Investor Relations<\/strong>\n          <\/td>\n<td>\n            <strong>Investor Relations (US)<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td>investors@anteristech.com<\/td>\n<td>mchatterjee@bplifescience.com<\/td>\n<\/tr>\n<tr>\n<td>Debbie Ormsby<\/td>\n<td>Malini Chatterjee, Ph.D.<\/td>\n<\/tr>\n<tr>\n<td>Anteris Technologies Global Corp.<\/td>\n<td>Blueprint Life Science Group<\/td>\n<\/tr>\n<tr>\n<td>+61 1300 550 310 | +61 7 3152 3200<\/td>\n<td>+1 917 330 4269<\/td>\n<\/tr>\n<\/table>\n<p>\n        \n      <\/p>\n<table style=\"border-collapse: collapse;width:99%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:15%;width:15%;min-width:15%\">Website<\/td>\n<td style=\"max-width:85%;width:85%;min-width:85%\">www.anteristech.com<\/td>\n<\/tr>\n<tr>\n<td>X<\/td>\n<td>@AnterisTech<\/td>\n<\/tr>\n<tr>\n<td>LinkedIn<\/td>\n<td>https:\/\/www.linkedin.com\/company\/anteristech<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">\n        \n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg2NzY3NSM3OTM4Njg0IzIyNjIyMTM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZjQwZTMyODQtZDM0Yi00MjVlLTgxODUtMTUzZTIyZGM4OWE5LTEyNzM3NjMtMjAyNi0xMS0wMS1lbg==\/tiny\/Anteris-Technologies-Pty-Ltd.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) &#8212; Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR\u00ae Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 \u00b1 38 mm2). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch* (PPM) in a cohort of medium annuli patients from the EMBARK Study. The 30-day Medium-size &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1015930","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) &#8212; Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR\u00ae Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 \u00b1 38 mm2). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch* (PPM) in a cohort of medium annuli patients from the EMBARK Study. 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Market Newsdesk","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:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/","og_locale":"en_US","og_type":"article","og_title":"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026 - Market Newsdesk","og_description":"MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) &#8212; Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR\u00ae Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 \u00b1 38 mm2). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch* (PPM) in a cohort of medium annuli patients from the EMBARK Study. The 30-day Medium-size &hellip; Continue reading \"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/","og_site_name":"Market Newsdesk","article_published_time":"2026-11-01T20:02:35+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg2NzY3NSM3OTM4Njg0IzIyNjIyMTM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026","datePublished":"2026-11-01T20:02:35+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/"},"wordCount":978,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg2NzY3NSM3OTM4Njg0IzIyNjIyMTM=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-reports-medium-size-duravr-thv-outcomes-from-the-embark-study-at-tct-2026\/","name":"Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026 - 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