{"id":508275,"date":"2021-06-30T09:04:45","date_gmt":"2021-06-30T13:04:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\/"},"modified":"2021-06-30T09:04:45","modified_gmt":"2021-06-30T13:04:45","slug":"abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\/","title":{"rendered":"Abbott&#8217;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients"},"content":{"rendered":"<div class=\"xn-newslines\">\n<h2 class=\"xn-hedline\">&#8211; New labeling approval for Abbott&#8217;s XIENCE\u2122 stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR)<\/h2>\n<h2 class=\"xn-hedline\">&#8211; The new XIENCE Skypoint\u2122 stent received FDA approval in the U.S. and CE Mark approval in Europe<\/h2>\n<h2 class=\"xn-hedline\">&#8211; XIENCE stents have 10+ years of clinical data across 120 clinical trials, more than 125,000 patients and 15 million stent\u00b9 implants<\/h2>\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>ABBOTT PARK, Ill., <span class=\"xn-chron\">June 30, 2021<\/span> \/PRNewswire\/ &#8212;\u00a0Abbott (NYSE: ABT) today announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the U.S. In addition, XIENCE stents recently received CE Mark approval for DAPT as short as 28 days \u2013 giving XIENCE stents the shortest DAPT indication in the world.<\/p>\n<p>In addition to the HBR indication, Abbott has also received FDA approval and European CE Mark approval for its next-generation XIENCE Skypoint stent. XIENCE Skypoint is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.<\/p>\n<p>&#8220;The new FDA approval for DAPT for the XIENCE family of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk. \u00a0A short DAPT duration minimizes risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance,&#8221; says <span class=\"xn-person\">Roxana Mehran<\/span>, M.D., professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai and the global principal investigator for Abbott&#8217;s Short DAPT program (XIENCE 28 and XIENCE 90).<\/p>\n<p>Stents are a critical therapy option to open blood vessels that have been clogged by calcium or fatty deposits. Following stent implantation, DAPT is routinely prescribed to help prevent clotting (thrombosis), which can block a blood vessel and potentially result in heart attack or death. However, DAPT can also increase the risk of bleeding complications in some patients.<sup>2<\/sup>\u00a0In fact, of all patients undergoing stenting procedures, approximately one in five are considered at high risk for bleeding.<sup>3<\/sup>\u00a0<\/p>\n<p>Patients who receive stents are typically on DAPT regimens (aspirin and P2Y12 inhibitors) for six to 12 months to prevent blood clots from blocking the stented vessel. However, HBR patients can experience side effects such as bleeding during prolonged courses of DAPT. With the shortest approved DAPT labeling, Abbott&#8217;s XIENCE stents can help physicians treat their HBR patients more effectively. Abbott&#8217;s <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=3593725710&amp;u=https%3A%2F%2Fwww.cardiovascular.abbott%2Fint%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family%2Fxience-trial-results.html&amp;a=XIENCE+28+and+XIENCE+90\" rel=\"nofollow noopener\">XIENCE 28 and XIENCE 90<\/a><sup>4<\/sup>\u00a0studies show that DAPT can be safely discontinued early as short as 28 days with no increased risk in patient adverse events, solidifying the industry-leading safety profile of the XIENCE family of stents.<\/p>\n<p>\n        <b>XIENCE SKYPOINT: INNOVATION FOR OPTIMAL PATIENT CARE<br \/><\/b>XIENCE Skypoint, the latest in a line of trusted XIENCE stents, is now approved for use in HBR patients with one-month DAPT labeling \u2013 as short as 28 days \u2013 in the U.S. and in <span class=\"xn-location\">Europe<\/span>. Supported by 10 years of clinical data, including 120 clinical trials studying 125,000 patients and the implantation of 15 million stents, XIENCE drug-eluting stents (DES) have been proven safe and effective, consistently delivering successful patient outcomes.<\/p>\n<p>&#8220;Even small differences between stents can impact both short- and long-term patient outcomes, and this latest generation of the XIENCE stent\u00a0offers multiple improvements that provide enhanced deliverability and expansion capability,&#8221; said <span class=\"xn-person\">Nick West<\/span>, M.D., chief medical officer and divisional vice president of global medical affairs at Abbott&#8217;s vascular business. &#8220;As we continue to innovate at Abbott, we are delivering medical technology that improves patients&#8217; lives, while\u00a0building a body of research evidence that underlines clinical consistency and patient safety.&#8221;<\/p>\n<p>XIENCE is supported by the largest body of DAPT patient evidence, with over 24,000 patients analyzed.<sup>5<\/sup> Abbott continues to focus on further improving the class-leading XIENCE stent platform through innovation, supported by clinical data from the most complex patient populations, including HBR, with the aim of driving optimal care for patients suffering from coronart heart disease.<\/p>\n<p>Important Safety Information: <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=3529874177&amp;u=https%3A%2F%2Fwww.cardiovascular.abbott%2Fus%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family%2Fxience-skypoint.html%23full_button_target&amp;a=XIENCE+Drug-Eluting+Stents+%7C+Abbott+(cardiovascular.abbott)\" rel=\"nofollow noopener\">XIENCE Drug-Eluting Stents | Abbott (cardiovascular.abbott)<\/a><\/p>\n<p>\n        <b>About Abbott:<br \/><\/b>Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.<\/p>\n<p>Connect with us at\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=989728129&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2582636-1%26h%3D2231282813%26u%3Dhttp%253A%252F%252Fwww.abbott.com%252F%26a%3Dwww.abbott.com&amp;a=www.abbott.com\" rel=\"nofollow noopener\">www.abbott.com<\/a>, on LinkedIn at\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=609143383&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2582636-1%26h%3D3209988505%26u%3Dhttp%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fabbott-%252F%26a%3Dwww.linkedin.com%252Fcompany%252Fabbott-%252F&amp;a=www.linkedin.com%2Fcompany%2Fabbott-%2F\" rel=\"nofollow noopener\">www.linkedin.com\/company\/abbott-\/<\/a>, on Facebook at\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=2994630049&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2582636-1%26h%3D2556518218%26u%3Dhttp%253A%252F%252Fwww.facebook.com%252FAbbott%26a%3Dwww.facebook.com%252FAbbott&amp;a=www.facebook.com%2FAbbott\" rel=\"nofollow noopener\">www.facebook.com\/Abbott<\/a>\u00a0and on Twitter <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=4028045515&amp;u=https%3A%2F%2Ftwitter.com%2FAbbottNews&amp;a=%40AbbottNews\" rel=\"nofollow noopener\">@AbbottNews<\/a>. <\/p>\n<div>\n<table id=\"convertedTable5833\" cellspacing=\"0\" cellpadding=\"0\" border=\"1\" class=\"prntblns\">\n<tr>\n<td class=\"prnsbtb1 prnrbrb1 prnvab prnsbbs prnpl6 prnsblb1 prnpr6\">\n              \n            <\/td>\n<td class=\"prngen3\">\n              \n            <\/td>\n<td class=\"prngen3\">\n              \n            <\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"prngen3\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>1<\/sup>\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=1238707367&amp;u=https%3A%2F%2Fwww.cardiovascular.abbott%2Fus%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family.html&amp;a=https%3A%2F%2Fwww.cardiovascular.abbott%2Fus%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family.html\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/www.cardiovascular.abbott\/us\/en\/hcp\/products\/percutaneous-coronary-intervention\/xience-family.html<\/a><\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"prngen3\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>2<\/sup>\u00a0Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006;114:774\u201382.<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"prngen3\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>3<\/sup>\u00a0Shanmugam VB, Harper R, Meredith I, Malaiapan Y, Psaltis PJ. An overview of PCI in the very elderly. J Geriatr Cardiol 2015;174\u2212184<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"prngen3\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>4<\/sup>\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3213585-1&amp;h=536051574&amp;u=https%3A%2F%2Fwww.cardiovascular.abbott%2Fint%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family%2Fxience-trial-results.html&amp;a=https%3A%2F%2Fwww.cardiovascular.abbott%2Fint%2Fen%2Fhcp%2Fproducts%2Fpercutaneous-coronary-intervention%2Fxience-family%2Fxience-trial-results.html\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/www.cardiovascular.abbott\/int\/en\/hcp\/products\/percutaneous-coronary-intervention\/xience-family\/xience-trial-results.html<\/a>\u00a0<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"prngen3\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>5<\/sup>\u00a0G\u00e9n\u00e9reux P, et al. Circ Cardiovasc Interv. 2015;8(5):1-16; Natsuaki et al., Cardiovasc Interv and Ther. 2016. 31:196\u2013209; Watanabe H, et al. JAMA. 2019;321(24):2414-2427; Hahn J, et al. ACC 2019 \u2013 SMART CHOICE; Valgimigli M, et al. Circulation. 2012;125:2015-2026; Gilard M, et al. J Am Coll Cardiol 2015;65:777-786; Hong SJ, et al. J Am Coll Cardiol Intv. 2016;9:1438\u20131446. Gwon HC, et al. ACC 2011 &#8211; EXCELLENT. Mehran R, et al. TCT Connect 2020. XIENCE 28\/90.<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\u00a0<\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CG28527&amp;sd=2021-06-30\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients-301323166.html\">https:\/\/www.prnewswire.com\/news-releases\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients-301323166.html<\/a><\/p>\n<p>SOURCE  Abbott<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CG28527&amp;Transmission_Id=202106300900PR_NEWS_USPR_____CG28527&amp;DateId=20210630\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; New labeling approval for Abbott&#8217;s XIENCE\u2122 stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR) &#8211; The new XIENCE Skypoint\u2122 stent received FDA approval in the U.S. and CE Mark approval in Europe &#8211; XIENCE stents have 10+ years of clinical data across 120 clinical trials, more than 125,000 patients and 15 million stent\u00b9 implants PR Newswire ABBOTT PARK, Ill., June 30, 2021 \/PRNewswire\/ &#8212;\u00a0Abbott (NYSE: ABT) today announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the U.S. &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Abbott&#8217;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk 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-508275","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>Abbott&#039;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk 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\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abbott&#039;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"&#8211; New labeling approval for Abbott&#8217;s XIENCE\u2122 stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR) &#8211; The new XIENCE Skypoint\u2122 stent received FDA approval in the U.S. and CE Mark approval in Europe &#8211; XIENCE stents have 10+ years of clinical data across 120 clinical trials, more than 125,000 patients and 15 million stent\u00b9 implants PR Newswire ABBOTT PARK, Ill., June 30, 2021 \/PRNewswire\/ &#8212;\u00a0Abbott (NYSE: ABT) today announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the U.S. &hellip; Continue reading &quot;Abbott&#8217;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-06-30T13:04:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CG28527&amp;sd=2021-06-30\" \/>\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=\"5 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\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Abbott&#8217;s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients\",\"datePublished\":\"2021-06-30T13:04:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/\"},\"wordCount\":927,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/c212.net\\\/c\\\/img\\\/favicon.png?sn=CG28527&amp;sd=2021-06-30\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/abbotts-xience-stent-receives-fda-approval-for-shortest-blood-thinner-course-for-high-bleeding-risk-patients\\\/\",\"name\":\"Abbott's XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients - 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