{"id":836873,"date":"2025-04-14T08:05:19","date_gmt":"2025-04-14T12:05:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/"},"modified":"2025-04-14T08:05:19","modified_gmt":"2025-04-14T12:05:19","slug":"edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/","title":{"rendered":"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwuline { text-decoration: underline }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>Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System<\/b><\/p>\n<p>IRVINE, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nEdwards Lifesciences Corporation (NYSE: EW) today announced the company\u2019s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company\u2019s SAPIEN technology, the SAPIEN M3 system is the world&#8217;s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR.\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\/20250414835786\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250414835786\/en\/<\/a><\/p>\n<div id=\"bwbodyimg\" style=\"width: 480px;float:left;padding-left:0px;padding-right:20px;padding-top:0px;padding-bottom:0px\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250414835786\/en\/2437737\/4\/Sapien_M3.jpg\" alt=\"Edwards' SAPIEN M3 Transcatheter Mitral Valve Replacement System\" \/><\/p>\n<p style=\"font-size:85%\">Edwards&#8217; SAPIEN M3 Transcatheter Mitral Valve Replacement System<\/p>\n<\/div>\n<p>\n\u201cEdwards\u2019 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations and the SAPIEN M3 system is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position,\u201d said Daveen Chopra, Edwards\u2019 corporate vice president, transcatheter mitral and tricuspid therapies. \u201cWe were the first to gain CE Mark for a transcatheter tricuspid valve replacement system, and with the SAPIEN M3 system\u2019s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the broad and diverse needs of these patients in Europe.\u201d\n<\/p>\n<p>\nThe procedure for the SAPIEN M3 system involves two steps, delivering the dock and then the valve to completely replace the mitral valve. The dock wraps around the native mitral leaflets which pulls them and the chordae inward toward the center of the dock, bringing the papillary muscles closer together. The dock creates a stable and consistent landing zone for placing the SAPIEN M3 valve. Both the dock and the valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.\n<\/p>\n<p>\n\u201cMitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,\u201d said Dr. Michael Mullen, Barts Heart Centre, St Bartholomew\u2019s Hospital, London, UK. \u201cThe SAPIEN M3 system establishes a new pathway for care with its novel docking mechanism and transseptal access, providing an important new treatment option for patients unsuitable for surgery or TEER.\u201d\n<\/p>\n<p>\nData have shown that the SAPIEN M3 system substantially reduces MR and improves quality of life. The company expects to present results from the ENCIRCLE pivotal trial, studying the SAPIEN M3 system, in late 2025. As part of Edwards\u2019 commitment to building a body of real-world evidence, a European Post-Market Clinical Follow-up Study is planned to continue evaluation of the SAPIEN M3 system, with patients followed up to five years.\n<\/p>\n<p>\nEdwards\u2019 portfolio of transcatheter mitral and tricuspid therapies with CE Mark also includes the PASCAL Precision mitral and tricuspid valve repair system, and the EVOQUE tricuspid valve replacement system. The SAPIEN M3 system is not yet approved in the United States.\n<\/p>\n<p><b><span class=\"bwuline\">About Edwards Lifesciences<\/span><\/b><\/p>\n<p>\nEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.edwards.com&amp;esheet=54237524&amp;newsitemid=20250414835786&amp;lan=en-US&amp;anchor=www.edwards.com&amp;index=1&amp;md5=57f640971e9c2bef0365f33207928ba6\">www.edwards.com<\/a> and follow us on LinkedIn, Facebook, Instagram and YouTube.\n<\/p>\n<p>\nThis news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, procedure objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.\n<\/p>\n<p>\nForward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company&#8217;s filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.\n<\/p>\n<p>\nEdwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN M3, ENCIRCLE, EVOQUE, PASCAL, PASCAL Precision, SAPIEN, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250414835786r1&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\/20250414835786\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250414835786\/en\/<\/a><\/span><\/p>\n<p>\nMedia Contact: Loree Bowen, 714-403-2475<br \/>\n<br \/>Investor Contact: Mark Wilterding, 949-250-6826\n<\/p>\n<p><b>KEYWORDS:<\/b> Europe United States United Kingdom North America California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health Medical Devices Surgery Health Technology Clinical Trials Cardiology Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\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\/20250414835786\/en\/2437737\/3\/Sapien_M3.jpg\" alt=\"Photo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\">Edwards&#8217; SAPIEN M3 Transcatheter Mitral Valve Replacement System<\/font><\/td>\n<\/tr>\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\/20250414835786\/en\/2437736\/3\/Preferred_Edwards_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System IRVINE, Calif.&#8211;(BUSINESS WIRE)&#8211; Edwards Lifesciences Corporation (NYSE: EW) today announced the company\u2019s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company\u2019s SAPIEN technology, the SAPIEN M3 system is the world&#8217;s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20250414835786\/en\/ Edwards&#8217; SAPIEN M3 Transcatheter Mitral Valve Replacement System \u201cEdwards\u2019 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System&#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-836873","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>Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System - 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\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System IRVINE, Calif.&#8211;(BUSINESS WIRE)&#8211; Edwards Lifesciences Corporation (NYSE: EW) today announced the company\u2019s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company\u2019s SAPIEN technology, the SAPIEN M3 system is the world&#8217;s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20250414835786\/en\/ Edwards&#8217; SAPIEN M3 Transcatheter Mitral Valve Replacement System \u201cEdwards\u2019 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved &hellip; Continue reading &quot;Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-04-14T12:05:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20250414835786\/en\/2437737\/4\/Sapien_M3.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=\"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\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System\",\"datePublished\":\"2025-04-14T12:05:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/\"},\"wordCount\":864,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250414835786\\\/en\\\/2437737\\\/4\\\/Sapien_M3.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\\\/\",\"name\":\"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System - 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Leveraging the company\u2019s SAPIEN technology, the SAPIEN M3 system is the world&#8217;s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20250414835786\/en\/ Edwards&#8217; SAPIEN M3 Transcatheter Mitral Valve Replacement System \u201cEdwards\u2019 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved &hellip; Continue reading \"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/","og_site_name":"Market Newsdesk","article_published_time":"2025-04-14T12:05:19+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20250414835786\/en\/2437737\/4\/Sapien_M3.jpg","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\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System","datePublished":"2025-04-14T12:05:19+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/"},"wordCount":864,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20250414835786\/en\/2437737\/4\/Sapien_M3.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/edwards-sapien-m3-receives-ce-mark-becoming-worlds-first-transfemoral-transcatheter-mitral-valve-replacement-system\/","name":"Edwards SAPIEN M3 Receives CE Mark, Becoming World\u2019s First Transfemoral Transcatheter Mitral Valve Replacement System - 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