{"id":900669,"date":"2025-10-27T15:11:02","date_gmt":"2025-10-27T19:11:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/"},"modified":"2025-10-27T15:11:02","modified_gmt":"2025-10-27T19:11:02","slug":"successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/","title":{"rendered":"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025"},"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>Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025<\/b><\/p>\n<p class=\"bwalignc\"><b>ENCIRCLE mitral trial achieves primary and secondary endpoints<br \/>\n<br \/>EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial<\/b><\/p>\n<p>SAN FRANCISCO&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nEdwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in <i>The Lancet<\/i>. Thirty-day data from the EVOQUE system STS\/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.<\/p>\n<p><span class=\"bwuline\">ENCIRCLE Pivotal Trial Results<\/span><\/p>\n<p>\nOne-year outcomes in the ENCIRCLE trial\u2019s main cohort (299 patients unsuitable for other treatment options) achieved low rates for death and low heart failure hospitalization for patients treated with the SAPIEN M3 transfemoral transcatheter mitral valve replacement (TMVR) system. Further, patients receiving the SAPIEN M3 valve therapy achieved substantial mitral regurgitation (MR) elimination (95.7% MR \u2264 0\/1+) and significant improvements in symptoms and quality-of-life.<\/p>\n<p>\n\u201cMitral regurgitation is highly prevalent. Many patients do not have good treatment options for mitral intervention, and therefore too many are left untreated. These patients often experience symptoms that are life threatening and significantly impact their quality-of-life,\u201d said David Daniels, M.D., Sutter West Bay Medical Group cardiologist, principal investigator and structural heart section chief of Sutter\u2019s Heart &amp; Vascular Service Line. \u201cThese ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a very low 30-day mortality in patients receiving a fully percutaneous mitral valve replacement using the SAPIEN M3 system. This is a significant step forward in the treatment of these patients.\u201d<\/p>\n<p><span class=\"bwuline\">EVOQUE TTVR System STS\/ACC TVT Registry Data<\/span><\/p>\n<p>\nWith data from 1,034 patients evaluated, findings from the EVOQUE TTVR system STS\/ACC TVT Registry demonstrated a positive real-world safety profile across a broad tricuspid patient population. This includes lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at 30 days compared to the TRISCEND II pivotal trial experience. Additionally, almost all patients experienced tricuspid regurgitation (TR) elimination (98% TR \u2264 0\/1+) and were discharged to home after a median stay of two days post-procedure.<\/p>\n<p>\n\u201cWe now have established a comprehensive portfolio of mitral and tricuspid repair and replacement technologies to ensure patients can receive the right therapy to meet their unique needs,\u201d said Daveen Chopra, Edwards\u2019 corporate vice president, transcatheter mitral and tricuspid therapies. \u201cThe depth and breadth of evidence across our therapies reinforces the compounding value our innovations continue to deliver for patients, physicians and the healthcare system.\u201d<\/p>\n<p>\nThe SAPIEN M3 system was approved in Europe in April 2025 and is not yet approved in the US. The EVOQUE system is approved in both the US and Europe.<\/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=54345553&amp;newsitemid=20251027759798&amp;lan=en-US&amp;anchor=www.edwards.com&amp;index=1&amp;md5=80b91956c19e981319ee46938f56a7e2\">www.edwards.com<\/a> and follow us on LinkedIn, Facebook, Instagram and YouTube.<\/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, including quality of life and length of stay, value delivered to patients, physicians and the healthcare system 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.<\/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.<\/p>\n<p>\nEdwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, EVOQUE, SAPIEN, SAPIEN M3, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251027759798r1&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\/20251027759798\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20251027759798\/en\/<\/a><\/span><\/p>\n<p>\nMedia Contact: Loree Bowen, 714-403-2475<br \/>\n<br \/>Investor Contact: Mark Wilterding, 949-250-6826<\/p>\n<p><b>KEYWORDS:<\/b> California United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Cardiology Biotechnology Surgery General Health Health Medical Devices Health Technology Clinical Trials<\/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\/20251027759798\/en\/2621560\/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>Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 ENCIRCLE mitral trial achieves primary and secondary endpoints EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial SAN FRANCISCO&#8211;(BUSINESS WIRE)&#8211; Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS\/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025&#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-900669","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>Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 - 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\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 ENCIRCLE mitral trial achieves primary and secondary endpoints EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial SAN FRANCISCO&#8211;(BUSINESS WIRE)&#8211; Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS\/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics &hellip; Continue reading &quot;Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-27T19:11:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251027759798r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\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\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025\",\"datePublished\":\"2025-10-27T19:11:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/\"},\"wordCount\":856,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20251027759798r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\\\/\",\"name\":\"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 - 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One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS\/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics &hellip; Continue reading \"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/","og_site_name":"Market Newsdesk","article_published_time":"2025-10-27T19:11:02+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251027759798r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","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\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025","datePublished":"2025-10-27T19:11:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/"},"wordCount":856,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20251027759798r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/successful-patient-outcomes-demonstrated-with-edwards-sapien-m3-and-evoque-systems-new-data-presented-at-tct-2025\/","name":"Successful Patient Outcomes Demonstrated With Edwards\u2019 SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025 - 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