{"id":32988,"date":"2025-09-08T20:01:00","date_gmt":"2025-09-08T20:01:00","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/sirtex-receives-expanded-ce-mark-approval-for-sir-spheres-y-90-resin-microspheres\/"},"modified":"2025-09-08T20:01:00","modified_gmt":"2025-09-08T20:01:00","slug":"sirtex-receives-expanded-ce-mark-approval-for-sir-spheres-y-90-resin-microspheres","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=32988","title":{"rendered":"Sirtex Receives Expanded CE Mark Approval for SIR-Spheres\u00ae Y-90 Resin Microspheres"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/926923\/Sirtex_Medical_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"prntac\"><i>Broadened indication increases access to liver cancer treatment across <span class=\"xn-location\">Europe<\/span> and CE-marked territories.<\/i><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">WOBURN, Mass.<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Sept. 8, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4502908-1&amp;h=3173499341&amp;u=http%3A%2F%2Fwww.sirtex.com%2Fus%2F&amp;a=Sirtex+Medical+(%22Sirtex%22)\" target=\"_blank\" rel=\"nofollow\">Sirtex Medical (&#8220;Sirtex&#8221;)<\/a>, a leading manufacturer of minimally invasive interventional oncology solutions, today announced that it has received an expanded CE Mark approval for SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres for the treatment of patients with liver cancer. With this expansion, eligibility now covers both primary and secondary liver metastases, increasing patient access to a well-established, targeted therapy.<\/p>\n<p>&#8220;This milestone is about more than regulatory approval\u2014it&#8217;s about giving hope and options back to patients facing some of the toughest cancer diagnoses,&#8221; said <span class=\"xn-person\">Matt Schmidt<\/span>, CEO of Sirtex Medical. &#8220;By expanding access to SIR-Spheres\u00ae, we&#8217;re ensuring that more people can benefit from a well-tolerated therapy when they need it most.&#8221;<\/p>\n<p>Radioembolization\u2014also known as selective internal radiation therapy (SIRT)\u2014delivers yttrium-90 directly to tumors via the hepatic artery, allowing for high-dose, targeted radiation aiming to minimize impact to surrounding healthy tissue.<\/p>\n<p>&#8220;<span class=\"xn-money\">Y-90<\/span> radioembolization has long demonstrated clinical value in managing complex liver tumors,&#8221; said Prof. Dr. med. <span class=\"xn-person\">Jens Ricke<\/span>, Director of the Clinic and Polyclinic of Radiology at the University Hospital Ludwig-Maximilians in <span class=\"xn-location\">Munich<\/span>, Germany.\u00a0&#8220;With this expanded CE Mark, more patients will have access to a therapy that can extend life, improve quality of life, and offer hope when other treatments may no longer be effective.&#8221;<\/p>\n<p>The CE Mark expansion follows an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres\u00ae across diverse liver metastases. Together with the FDA&#8217;s recent approval of SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres for the treatment of unresectable HCC in <span class=\"xn-location\">the United States<\/span>, this milestone underscores the growing global recognition of SIR-Spheres\u00ae as a versatile, differentiated therapy and reinforces the Sirtex commitment to advancing liver-directed interventional oncology.<\/p>\n<p>For more information and details on how to incorporate SIR-Spheres\u00ae into your practice, please contact Sirtex at\u00a0<a href=\"mailto:info-use@sirtex.com\" target=\"_blank\" rel=\"nofollow\"><b>info-use@sirtex.com<\/b><\/a>.<\/p>\n<p><b>About SIR-Spheres<\/b><b>\u00ae in <span class=\"xn-location\">Europe<\/span><br \/><\/b>SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres are indicated for the treatment of:<\/p>\n<ul type=\"disc\">\n<li>Unresectable hepatocellular carcinoma (HCC), or<\/li>\n<li>Unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy, or<\/li>\n<li>Unresectable intrahepatic cholangiocarcinoma (iCCA), or<\/li>\n<li>Hepatic metastases by neuroendocrine tumours (mNET), or<\/li>\n<li>Other liver metastases<\/li>\n<\/ul>\n<p><b>Caution: Consult the Instructions for Use for a complete listing of indications, contraindications, side effects, warnings and precautions. <\/b><\/p>\n<p><b>About Sirtex<br \/><\/b>Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Europe<\/span>, and <span class=\"xn-location\">Asia<\/span>, Sirtex delivers innovative minimally invasive interventional oncology and embolization solutions to physicians and patients worldwide. For more information, visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4502908-1&amp;h=1004960961&amp;u=http%3A%2F%2Fwww.sirtex.com%2F&amp;a=www.sirtex.com\" target=\"_blank\" rel=\"nofollow\">www.sirtex.com<\/a>.<\/p>\n<p>APM-EMEA-009-07-25<\/p>\n<p>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/926923\/Sirtex_Medical_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"prntac\"><i>Broadened indication increases access to liver cancer treatment across <span class=\"xn-location\">Europe<\/span> and CE-marked territories.<\/i><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">WOBURN, Mass.<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Sept. 8, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4502908-1&amp;h=3173499341&amp;u=http%3A%2F%2Fwww.sirtex.com%2Fus%2F&amp;a=Sirtex+Medical+(%22Sirtex%22)\" target=\"_blank\" rel=\"nofollow\">Sirtex Medical (&#8220;Sirtex&#8221;)<\/a>, a leading manufacturer of minimally invasive interventional oncology solutions, today announced that it has received an expanded CE Mark approval for SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres for the treatment of patients with liver cancer. With this expansion, eligibility now covers both primary and secondary liver metastases, increasing patient access to a well-established, targeted therapy.<\/p>\n<p>&#8220;This milestone is about more than regulatory approval\u2014it&#8217;s about giving hope and options back to patients facing some of the toughest cancer diagnoses,&#8221; said <span class=\"xn-person\">Matt Schmidt<\/span>, CEO of Sirtex Medical. &#8220;By expanding access to SIR-Spheres\u00ae, we&#8217;re ensuring that more people can benefit from a well-tolerated therapy when they need it most.&#8221;<\/p>\n<p>Radioembolization\u2014also known as selective internal radiation therapy (SIRT)\u2014delivers yttrium-90 directly to tumors via the hepatic artery, allowing for high-dose, targeted radiation aiming to minimize impact to surrounding healthy tissue.<\/p>\n<p>&#8220;<span class=\"xn-money\">Y-90<\/span> radioembolization has long demonstrated clinical value in managing complex liver tumors,&#8221; said Prof. Dr. med. <span class=\"xn-person\">Jens Ricke<\/span>, Director of the Clinic and Polyclinic of Radiology at the University Hospital Ludwig-Maximilians in <span class=\"xn-location\">Munich<\/span>, Germany.\u00a0&#8220;With this expanded CE Mark, more patients will have access to a therapy that can extend life, improve quality of life, and offer hope when other treatments may no longer be effective.&#8221;<\/p>\n<p>The CE Mark expansion follows an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres\u00ae across diverse liver metastases. Together with the FDA&#8217;s recent approval of SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres for the treatment of unresectable HCC in <span class=\"xn-location\">the United States<\/span>, this milestone underscores the growing global recognition of SIR-Spheres\u00ae as a versatile, differentiated therapy and reinforces the Sirtex commitment to advancing liver-directed interventional oncology.<\/p>\n<p>For more information and details on how to incorporate SIR-Spheres\u00ae into your practice, please contact Sirtex at\u00a0<a href=\"mailto:info-use@sirtex.com\" target=\"_blank\" rel=\"nofollow\"><b>info-use@sirtex.com<\/b><\/a>.<\/p>\n<p><b>About SIR-Spheres<\/b><b>\u00ae in <span class=\"xn-location\">Europe<\/span><br \/><\/b>SIR-Spheres\u00ae <span class=\"xn-money\">Y-90<\/span> resin microspheres are indicated for the treatment of:<\/p>\n<ul type=\"disc\">\n<li>Unresectable hepatocellular carcinoma (HCC), or<\/li>\n<li>Unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy, or<\/li>\n<li>Unresectable intrahepatic cholangiocarcinoma (iCCA), or<\/li>\n<li>Hepatic metastases by neuroendocrine tumours (mNET), or<\/li>\n<li>Other liver metastases<\/li>\n<\/ul>\n<p><b>Caution: Consult the Instructions for Use for a complete listing of indications, contraindications, side effects, warnings and precautions. <\/b><\/p>\n<p><b>About Sirtex<br \/><\/b>Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Europe<\/span>, and <span class=\"xn-location\">Asia<\/span>, Sirtex delivers innovative minimally invasive interventional oncology and embolization solutions to physicians and patients worldwide. For more information, visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4502908-1&amp;h=1004960961&amp;u=http%3A%2F%2Fwww.sirtex.com%2F&amp;a=www.sirtex.com\" target=\"_blank\" rel=\"nofollow\">www.sirtex.com<\/a>.<\/p>\n<p>APM-EMEA-009-07-25<\/p>\n<p>\u00a0<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-32988","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/32988","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=32988"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/32988\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=32988"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=32988"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=32988"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}