{"id":885409,"date":"2025-09-11T06:33:06","date_gmt":"2025-09-11T10:33:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/"},"modified":"2025-09-11T06:33:06","modified_gmt":"2025-09-11T10:33:06","slug":"first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/","title":{"rendered":"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients"},"content":{"rendered":"<h2>\nThe Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p>WAYNE, Pa., Sept.  11, 2025  (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.<\/p>\n<p>The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm to assess the leave-nothing behind approach. The study addresses a critical unmet need, as patients with diabetes continue to experience higher rates of stent failure despite advances in DES technology<sup>1<\/sup>.<\/p>\n<p>\u201cThis trial explores a promising approach to improve outcomes in a high-risk population,\u201d said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. \u201cBy combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested to see the impact on restenosis and long-term vessel health in patients with diabetes.\u201d<\/p>\n<p>The DUBSTENT DIABETES trial will enroll 120 diabetes patients across high-volume centers in Ireland. Participants will be randomized to receive either:<\/p>\n<ul type=\"disc\">\n<li style=\"margin-top:12pt\">A combination of the Pantera\u2122 Lux\u2122 DCB Catheter (which is part of the Lux\u2122\u00a0family of Paclitaxel-coated balloons) and the Orsiro\u2122 Mission\u2122 DES<\/li>\n<li style=\"margin-top:12pt\">The Pantera\u2122 Lux\u2122 DCB Catheter alone<\/li>\n<li style=\"margin-top:12pt\">The Orsiro\u2122 Mission\u2122 DES alone\n<\/li>\n<\/ul>\n<p>The primary endpoint is percentage diameter stenosis at six months, assessed by quantitative coronary angiography. Secondary endpoints include death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and quality of life up to five years.<\/p>\n<p>\u201cWe are committed to advancing evidence-based solutions for complex patient populations,\u201d said Prof. Dr. Georg Nollert, Vice President Medical Affairs for Vascular Intervention at Teleflex. \u201cWe are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.\u201d<\/p>\n<p>\n        <strong>About<\/strong><br \/>\n        <strong>Teleflex<\/strong><br \/>\n        <strong>Incorporated<\/strong><br \/>\n        <br \/>As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people\u2019s lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.<\/p>\n<p>Teleflex is the home of Arrow\u2122, Barrigel\u2122, Deknatel\u2122, LMA\u2122, Pilling\u2122, QuikClot\u2122, R\u00fcsch\u2122, UroLift\u2122 and Weck\u2122 \u2013 trusted brands united by a common sense of purpose.<\/p>\n<p>At Teleflex, we are empowering the future of healthcare. For more information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=BynGOj1vuiClTGusp8ITpAUx3ul4zhhmDn3uN7hLW9lgiQU0oXav2Z66BxITsJgYGwJqCjpNeFy81jIGuuLAwg==\" rel=\"nofollow\" target=\"_blank\"><u>teleflex.com<\/u><\/a>.<\/p>\n<p>Not all products may be available in all countries. The Pantera\u2122 Lux\u2122 Drug-Coated Balloon Catheter is not approved in United States and the Freesolve\u2122 Resorbable Magnesium Scaffold (RMS) is limited to investigational use in the United States. Indications for use may vary by geographic location.<\/p>\n<p>*Professor Byrne is a paid consultant of Teleflex Incorporated or its affiliates.<\/p>\n<p>**Study sponsored by Teleflex Incorporated or its affiliates.<\/p>\n<p>\n        <strong>Forward-Looking<\/strong><br \/>\n        <strong>Statements<\/strong><br \/>\n        <br \/>Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management&#8217;s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.<\/p>\n<p>\n        <em>CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.<\/em>\n      <\/p>\n<p>\n        <em>Freesolve\u2122<\/em><br \/>\n        <em>RMS CAUTION: <\/em><br \/>\n        <em>I<\/em><br \/>\n        <em>nvestigational device. Limited by Federal (or United States) law to investigational use.<\/em>\n      <\/p>\n<p>\n        <em>Teleflex,<\/em><br \/>\n        <em>the<\/em><br \/>\n        <em>Teleflex<\/em><br \/>\n        <em>logo,<\/em><br \/>\n        <em>Arrow,<\/em><br \/>\n        <em>Barrigel,<\/em><br \/>\n        <em>Deknatel,<\/em><br \/>\n        <em>Freesolve,<\/em><br \/>\n        <em>LMA,<\/em><br \/>\n        <em>Lux,<\/em><br \/>\n        <em>Mission,<\/em><br \/>\n        <em>Orsiro,<\/em><br \/>\n        <em> Orsiro Mission, <\/em><br \/>\n        <em>Pantera,<\/em><br \/>\n        <em>Pilling, QuikClot,<\/em><br \/>\n        <em>R\u00fcsch,<\/em><br \/>\n        <em>UroLift,<\/em><br \/>\n        <em>and<\/em><br \/>\n        <em>Weck<\/em><br \/>\n        <em>are<\/em><br \/>\n        <em>trademarks<\/em><br \/>\n        <em>or<\/em><br \/>\n        <em>registered<\/em><br \/>\n        <em>trademarks<\/em><br \/>\n        <em>of<\/em><br \/>\n        <em>Teleflex<\/em><br \/>\n        <em>Incorporated<\/em><br \/>\n        <em>or<\/em><br \/>\n        <em>its <\/em><br \/>\n        <em>affiliates<\/em><br \/>\n        <em>in<\/em><br \/>\n        <em>the<\/em><br \/>\n        <em>U.S.<\/em><br \/>\n        <em>and\/or<\/em><br \/>\n        <em>other<\/em><br \/>\n        <em>countries.<\/em><br \/>\n        <em>\u00a0Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this press release is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. <\/em>\n      <\/p>\n<p>\n        <em>\u00a9<\/em><br \/>\n        <em>2025<\/em><br \/>\n        <em>Teleflex<\/em><br \/>\n        <em>Incorporated.<\/em><br \/>\n        <em>All<\/em><br \/>\n        <em>rights<\/em><br \/>\n        <em>reserved.<\/em><br \/>\n        <em>MC-011244<\/em><br \/>\n        <em>Rev <\/em><br \/>\n        <em>0.<\/em>\n      <\/p>\n<p>\n        <strong>References:<\/strong><br \/>\n        <br \/>1. <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=fEpC4I_dysDvVqKHp7QzH9yIZHcZ7GlU6mpWmKwraMOYzR9b-uSW7kDJF_4FEgWeqxEx6aOP40G3P8eqAnlFYHuD0re1wQKuOMCrs8vr2YY1V76upHF79UJLUzWQwbOhvTq-odOrr2wHZYw1HcebE3c9x3dtn2_TMlmN1LufTQc1jYyEkMGODzbKZQdYmTMq0K88MqETa0ylHBxWh0sM-BO-cTtlwEKPFvwEKWa3reU=\" rel=\"nofollow\" target=\"_blank\">https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.123.013302<\/a><\/p>\n<p>\n        <strong>Contacts:<\/strong><br \/>\n        <br \/>Teleflex Lawrence Keusch<br \/>Vice President, Investor Relations and Strategy Development <br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=F7N_c8AeMxaw5dLIDdXJ0wN_aBnMX5n3f9SZ_nCkt9cy3aDjb9kHiiQpkbU6_xBlOc8jYUd56_jjGS-GvvXQrGSKT0PYBqlydgbURzXpC4C-plClNztnCGoM4iHb7dcWFIZiIKWffrnN3h0wSFpE0g==\" rel=\"nofollow\" target=\"_blank\"><u>investor.relations@teleflex.com<\/u><\/a><br \/>610-948-2836<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyNjc4MSM3MTQwMzAwIzIwMDQ2NTA=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NDY0YTI0YzMtNjkwYy00YjE1LTk5NjEtZWQ4ODNiMzAyMjBiLTEwMTYyMjMtMjAyNS0wOS0xMS1lbg==\/tiny\/Teleflex-Incorporated.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients&#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-885409","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients - 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\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm &hellip; Continue reading &quot;First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-11T10:33:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyNjc4MSM3MTQwMzAwIzIwMDQ2NTA=\" \/>\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\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients\",\"datePublished\":\"2025-09-11T10:33:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/\"},\"wordCount\":799,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTUyNjc4MSM3MTQwMzAwIzIwMDQ2NTA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\\\/\",\"name\":\"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients - 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The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm &hellip; Continue reading \"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/","og_site_name":"Market Newsdesk","article_published_time":"2025-09-11T10:33:06+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyNjc4MSM3MTQwMzAwIzIwMDQ2NTA=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients","datePublished":"2025-09-11T10:33:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/"},"wordCount":799,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyNjc4MSM3MTQwMzAwIzIwMDQ2NTA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-dubstent-diabetes-trial-targeting-improved-pci-outcomes-for-diabetic-patients\/","name":"First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients - 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