{"id":830386,"date":"2025-03-27T06:33:19","date_gmt":"2025-03-27T10:33:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/"},"modified":"2025-03-27T06:33:19","modified_gmt":"2025-03-27T10:33:19","slug":"preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/","title":{"rendered":"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference"},"content":{"rendered":"<h2>\nProspective Multicenter Study Investigates Ringer\u2122\u00a0PBC for Management of Coronary Perforations<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">WAYNE, Pa., March  27, 2025  (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer\u2122\u00a0PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study\u2019s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.*<\/p>\n<p>Ringer\u2122 PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations.<sup>1<\/sup><\/p>\n<p>The Ringer\u2122 PBC study is a limited prospective, multi-center, single-arm IDE study, undertaken at four sites in the United States investigating the Ringer\u2122\u00a0PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention (PCI) procedures. The study enrolled 30 participants, and analysis was performed based upon intention-to-treat. The primary efficacy endpoint required successful Ringer\u2122 PBC delivery and inflation at the perforation site, control of extravasation (defined as residual Ellis grade 0 or 1), and preservation of antegrade coronary flow (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3).<\/p>\n<p>Of 30 participants enrolled, the primary efficacy endpoint was observed in 22 participants (73.3%), with successful Ringer\u2122\u00a0PBC delivery in 26 participants (86.7%). Among those participants with successful delivery, control of extravasation with perfusion was achieved in 22 participants (84.6%). Twelve participants were treated with a covered stent following perforation management with the Ringer\u2122\u00a0PBC. One participant required emergency surgery for complications of pericardiocentesis, and three participants died despite control of extravasation from the index perforation.<\/p>\n<p>&#8220;I believe these preliminary study results are important,\u201d said Dr. Kandzari. \u201cTreatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.\u201d<\/p>\n<p align=\"left\">For the investigational use of the management of coronary perforations, Ringer\u2122 PBC was granted the FDA\u2019s Breakthrough Device Designation, a program intended to provide patients and healthcare providers with timely access for certain medical devices that could potentially provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and DeNovo marketing authorizations.<\/p>\n<p align=\"left\">&#8220;Teleflex is committed to generating the clinical evidence to help physicians make confident decisions when selecting the right products for their patients\u2019 needs,\u201d said Teleflex Medical Director, Christopher Buller, MD.<\/p>\n<p>Ringer\u2122 PBC is currently indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion. The Ringer PBC in this study is an investigational device and not available for sale. Data from the study is intended to support a premarket application recently submitted to FDA.<\/p>\n<p>\n        <strong>About Teleflex 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 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\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HTXPiojPXcjSeAjUHbOYzG55B-fCV80yqW36mcbVXFJhKzhNYjXyb4WWYIe3qNBy6M8Nh83exwajnbcdg1gcxefl-KD2RChPPpbSwXIe2JXBwdxxiPSdxsAf8Wb1G27YxlhERTGzRpyyEwE9r3vK9C3K4Px7eG3IGisi1Dns_1JWPtN0JB_GMGTZhgXDlFbZyveXY7U2RYkhKSoD69lYPuXosNdoyXuGUx4aHNI98CI=\" rel=\"nofollow\" target=\"_blank\">teleflex.com.<\/a><\/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>*Dr. Kandzari is a paid consultant of Teleflex Incorporated or its affiliates.<\/p>\n<p align=\"justify\">\n        <strong>References:<\/strong>\n      <\/p>\n<ol style=\"list-style-type:decimal\">\n<li style=\"margin-top:0.25pt;text-align:left\">Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex.<\/li>\n<\/ol>\n<p>\n        <em>CAUTION\u2014Investigational device. Limited by Federal (or United States) law to investigational use.<\/em>\n      <\/p>\n<p>\n        <em>Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, Quik-Clot, Ringer, <\/em><br \/>\n        <em>R\u00fcsch, <\/em><br \/>\n        <em>UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and\/or other countries.\u00a0<\/em>\n      <\/p>\n<p>\n        <em>\u00a9 2025 Teleflex Incorporated. All rights reserved. MC-010629 Rev 0.<\/em>\n      <\/p>\n<p>\n        <strong>Contacts: <\/strong>\n      <\/p>\n<p>For Teleflex Incorporated:<br \/>Lawrence Keusch<br \/>Vice President, Investor Relations and Strategy Development<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=IAmFDQVM6Du1v9VCj-BEMGhzYkmPqzVj3Tg1NvCX6XMIpy4aLbmSU9Nl98b8Da5iqqEIueC2N7lPDGmUPeYUEi7xf-2_wNryAjx2m02L9BPS42ruOXVvcb37W3cSohdNEBrNHPQLILpGuXPaw3eYQQ==\" rel=\"nofollow\" target=\"_blank\">investor.relations@teleflex.com<\/a><br \/>610.948.2836<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxMTU4NCM2ODM1NzAzIzIwMDQ2NTA=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NDM5YjUwNGUtOTEzYi00MTQ4LWIzN2EtM2NkMmUxZWExOGNlLTEwMTYyMjMtMjAyNS0wMy0yNy1lbg==\/tiny\/Teleflex-Incorporated.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Prospective Multicenter Study Investigates Ringer\u2122\u00a0PBC for Management of Coronary Perforations WAYNE, Pa., March 27, 2025 (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer\u2122\u00a0PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study\u2019s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.* Ringer\u2122 PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference&#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-830386","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference - 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\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Prospective Multicenter Study Investigates Ringer\u2122\u00a0PBC for Management of Coronary Perforations WAYNE, Pa., March 27, 2025 (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer\u2122\u00a0PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study\u2019s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.* Ringer\u2122 PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood &hellip; Continue reading &quot;Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-27T10:33:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxMTU4NCM2ODM1NzAzIzIwMDQ2NTA=\" \/>\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\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference\",\"datePublished\":\"2025-03-27T10:33:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/\"},\"wordCount\":819,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQxMTU4NCM2ODM1NzAzIzIwMDQ2NTA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\\\/\",\"name\":\"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference - 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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\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/","og_locale":"en_US","og_type":"article","og_title":"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference - Market Newsdesk","og_description":"Prospective Multicenter Study Investigates Ringer\u2122\u00a0PBC for Management of Coronary Perforations WAYNE, Pa., March 27, 2025 (GLOBE NEWSWIRE) &#8212; Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer\u2122\u00a0PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study\u2019s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.* Ringer\u2122 PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood &hellip; Continue reading \"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/","og_site_name":"Market Newsdesk","article_published_time":"2025-03-27T10:33:19+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxMTU4NCM2ODM1NzAzIzIwMDQ2NTA=","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\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference","datePublished":"2025-03-27T10:33:19+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/"},"wordCount":819,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxMTU4NCM2ODM1NzAzIzIwMDQ2NTA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/preliminary-results-from-ide-study-on-ringer-perfusion-balloon-catheter-pbc-reported-from-podium-at-cto-plus-conference\/","name":"Preliminary Results from IDE Study on Ringer\u2122 Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference - 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