{"id":399830,"date":"2020-12-15T08:06:07","date_gmt":"2020-12-15T13:06:07","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399830"},"modified":"2020-12-15T08:06:07","modified_gmt":"2020-12-15T13:06:07","slug":"two-milestones-achieved-toward-small-bore-access-with-impella","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/","title":{"rendered":"Two Milestones Achieved Toward Small Bore Access with Impella"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Two Milestones Achieved Toward Small Bore Access with Impella<\/b><\/p>\n<p>\n\u00a0\n<\/p>\n<p>DANVERS, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nAbiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath.\n<\/p>\n<p id=\"news-body-cta\">This press release features multimedia. View the full release here: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/<\/a><\/p>\n<div id=\"bwbodyimg\" style=\"width: 342px;float:left;padding-left:0px;padding-right:20px;padding-top:0px;padding-bottom:0px\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846808\/4\/Picture1.jpg\" alt=\"The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire)\" \/><\/p>\n<p style=\"font-size:85%\">The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire)<\/p>\n<\/div>\n<p>\nThe Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during Impella delivery then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths.\n<\/p>\n<p>\nThe Impella XR sheath has been studied in patients outside of the United States on multiple occasions. The first patient in the U.S. is expected during Q4 of fiscal year 2021.\n<\/p>\n<p>\nAdditionally, Abiomed has successfully completed the first stage of the EFS of Impella ECP by enrolling and treating five patients. Impella ECP is the world\u2019s smallest heart pump. It measures 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands to support the heart\u2019s pumping function, providing peak flows greater than 3.5 L\/min.\n<\/p>\n<p>\nThe prospective, multi-center, non-randomized EFS is designed to allow Abiomed, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of Impella ECP use in high-risk percutaneous coronary intervention (PCI) patients. Abiomed will now submit data to the FDA and request to move to a second stage of the study with expanded enrollment.\n<\/p>\n<p>\n\u201cThese milestones are important steps toward the fulfillment of Abiomed\u2019s vision of creating an innovative portfolio of products that are smaller, smarter and more connected,\u201d said Chuck Simonton, MD, Abiomed\u2019s chief medical officer. \u201cDesign innovations like Impella ECP and Impella XR sheath will allow for a smaller access site with Impella, which will continue to drive better patient care and outcomes.\u201d\n<\/p>\n<p>\nImpella ECP is available for investigational use only and is not approved for use outside of clinical studies.\n<\/p>\n<p><b>ABOUT ABIOMED<\/b><\/p>\n<p>\nBased in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and\/or performing the pumping of the heart. For additional information, please visit: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.abiomed.com&amp;esheet=52348601&amp;newsitemid=20201215005395&amp;lan=en-US&amp;anchor=www.abiomed.com&amp;index=1&amp;md5=730767da99d371470b5f3247b7f8aba8\">www.abiomed.com<\/a>.\n<\/p>\n<p><b>ABOUT IMPELLA XR SHEATH<\/b><\/p>\n<p>\nThe Impella XR Sheath set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.\n<\/p>\n<p><b>ABOUT IMPELLA ECP<\/b><\/p>\n<p>\nCAUTION: Impella ECP is an investigational device, limited by federal law to investigational use only.\n<\/p>\n<p><b>ABOUT IMPELLA HEART PUMPS<\/b><\/p>\n<p>\nThe Impella 2.5\u00ae and Impella CP\u00ae devices are U.S. FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.\n<\/p>\n<p>\nThe Impella 2.5, Impella CP, Impella CP with SmartAssist\u00ae, Impella 5.0\u00ae, Impella LD\u00ae, and Impella 5.5\u00ae with SmartAssist\u00ae are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.\n<\/p>\n<p><b>FORWARD-LOOKING STATEMENTS<\/b><\/p>\n<p>\nThis press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Abiomed&#8217;s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201215005395r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/<\/a><\/span><\/p>\n<p>\nSarah Karr<br \/>\n<br \/>Communications Manager<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:skarr@abiomed.com\">skarr@abiomed.com<br \/>\n<\/a><br \/>(978) 882-8211\n<\/p>\n<p>\nTodd Trapp<br \/>\n<br \/>Vice President and Chief Financial Officer<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:ttrapp@abiomed.com\">ttrapp@abiomed.com<br \/>\n<\/a><br \/>(978) 646-1680\n<\/p>\n<p><b>KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> General Health Health Cardiology Medical Devices<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/722993\/3\/AbioLogo_TAGLINE_COLOR.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Photo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846808\/3\/Picture1.jpg\" alt=\"Photo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\">The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire)<\/font><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Photo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846809\/3\/ECP.jpg\" alt=\"Photo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\">Impella ECP is the world\u2019s smallest heart pump. (Photo: Business Wire)<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Two Milestones Achieved Toward Small Bore Access with Impella \u00a0 DANVERS, Mass.&#8211;(BUSINESS WIRE)&#8211; Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/ The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire) The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Two Milestones Achieved Toward Small Bore Access with Impella&#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-399830","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Two Milestones Achieved Toward Small Bore Access with Impella - 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\/two-milestones-achieved-toward-small-bore-access-with-impella\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Two Milestones Achieved Toward Small Bore Access with Impella - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Two Milestones Achieved Toward Small Bore Access with Impella \u00a0 DANVERS, Mass.&#8211;(BUSINESS WIRE)&#8211; Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/ The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire) The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 &hellip; Continue reading &quot;Two Milestones Achieved Toward Small Bore Access with Impella&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-15T13:06:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846808\/4\/Picture1.jpg\" \/>\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=\"3 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\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Two Milestones Achieved Toward Small Bore Access with Impella\",\"datePublished\":\"2020-12-15T13:06:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/\"},\"wordCount\":712,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20201215005395\\\/en\\\/846808\\\/4\\\/Picture1.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/two-milestones-achieved-toward-small-bore-access-with-impella\\\/\",\"name\":\"Two Milestones Achieved Toward Small Bore Access with Impella - 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The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20201215005395\/en\/ The Impella XR sheath inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire) The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 &hellip; Continue reading \"Two Milestones Achieved Toward Small Bore Access with Impella\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-15T13:06:07+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846808\/4\/Picture1.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Two Milestones Achieved Toward Small Bore Access with Impella","datePublished":"2020-12-15T13:06:07+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/"},"wordCount":712,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20201215005395\/en\/846808\/4\/Picture1.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/two-milestones-achieved-toward-small-bore-access-with-impella\/","name":"Two Milestones Achieved Toward Small Bore Access with Impella - 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