{"id":904012,"date":"2025-11-03T08:28:34","date_gmt":"2025-11-03T13:28:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\/"},"modified":"2025-11-03T08:28:34","modified_gmt":"2025-11-03T13:28:34","slug":"fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\/","title":{"rendered":"FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d)"},"content":{"rendered":"
\n

\n
\n PARADIGM<\/em>
\n <\/strong>
\n : A <\/em>
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\n rospective r<\/em>
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\n <\/em>
\n <\/strong>
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\n ssessing the safety and effectiveness of the <\/em>
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\n D<\/u>
\n <\/em>
\n <\/strong>
\n urAVR<\/em>
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\n \u00ae<\/em>
\n <\/sup>
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\n omimetic valve designed for physiolo<\/em>
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MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, <\/em>its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR\u00ae<\/sup> Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA*<\/sup> submission.<\/p>\n

\u201cWe are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,\u201d commented Vice Chairman and CEO, Wayne Paterson.\u00a0<\/p>\n

The PARADIGM Trial is co-chaired by Dr. Michael J. Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital, Texas and Professor Stephan Windecker, Chairman of the Department of Cardiology at Bern University Hospital, Switzerland.<\/p>\n

\n About the PARADIGM Trial<\/strong>\n <\/p>\n

The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR\u00ae<\/sup> THV compared to commercially available transcatheter aortic valve replacements (TAVRs).<\/p>\n

This head-to-head study will enroll approximately 1000 patients across the Unites States, Europe and Canada in the \u2018All Comers Randomized Cohort\u2019 with 1:1 randomization of patients who will receive either the DurAVR\u00ae<\/sup> 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

The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval in the United States, with CE Mark approval anticipated to progress in parallel to the PMA.<\/p>\n

For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265).<\/p>\n

*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups.<\/p>\n

**Subject to Institutional Review Board (IRB) approval<\/p>\n

\n About Anteris<\/strong>\n <\/p>\n

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart 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

Anteris\u2019 lead product, the DurAVR\u00ae<\/sup> Transcatheter Heart Valve (THV), was designed in partnership 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\u00ae<\/sup> 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\u00ae <\/sup>THV is made using a single piece of molded ADAPT\u00ae<\/sup> tissue, Anteris\u2019 patented anti-calcification tissue technology. ADAPT\u00ae<\/sup> 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\u00ae<\/sup> THV System is comprised of the DurAVR\u00ae<\/sup> valve, the ADAPT\u00ae<\/sup> tissue, and the balloon-expandable ComASUR\u00ae<\/sup> Delivery System.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This announcement contains forward-looking statements including statements regarding the intent for the PARADIGM Trial. 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, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.<\/p>\n

\n For more information:<\/strong>\n <\/p>\n

\n Investor Relations<\/strong>
\n
investor@anteristech.com
Debbie Ormsby
Anteris Technologies Global Corp.
+61 1300 550 310 | +61 7 3152 3200<\/p>\n

\n Investor Relations (US)<\/strong>
\n
\n mchatterjee@bplifescience.com<\/a>
\n
Malini Chatterjee, Ph.D.
Blueprint Life Science Group
+1 917 330 4269
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Website\u00a0 www.anteristech.com
X\u00a0 @AnterisTech
LinkedIn\u00a0 https:\/\/www.linkedin.com\/company\/anteristech<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

PARADIGM : A P rospective r A ndomized t R ial A ssessing the safety and effectiveness of the D urAVR \u00ae b I omimetic valve designed for physiolo G ic flow compared to Co M mercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR\u00ae Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA* submission. \u201cWe are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United … <\/p>\n

Continue reading “FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d)”<\/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-904012","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nFDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d) - 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\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PARADIGM : A P rospective r A ndomized t R ial A ssessing the safety and effectiveness of the D urAVR \u00ae b I omimetic valve designed for physiolo G ic flow compared to Co M mercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR\u00ae Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA* submission. \u201cWe are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United … Continue reading "FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d)"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-03T13:28:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU2NzA3NiM3MjM4ODg1IzIyNjIyMTM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d)\",\"datePublished\":\"2025-11-03T13:28:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/\"},\"wordCount\":806,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTU2NzA3NiM3MjM4ODg1IzIyNjIyMTM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-anteriss-duravr-thv-global-pivotal-trial-the-paradigm-trial\\\/\",\"name\":\"FDA Approves Anteris\u2019s DurAVR\u00ae THV Global Pivotal Trial (the \u201cPARADIGM Trial\u201d) - 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