{"id":55661,"date":"2025-09-17T17:52:16","date_gmt":"2025-09-17T12:22:16","guid":{"rendered":"https:\/\/prevalentindia.in\/index.php\/2025\/09\/17\/anvisa-grants-commercial-approval-to-concept-medicals-magictouch-sirolimus-coated-balloon-for-cad-in-brazil\/"},"modified":"2025-09-17T17:52:16","modified_gmt":"2025-09-17T12:22:16","slug":"anvisa-grants-commercial-approval-to-concept-medicals-magictouch-sirolimus-coated-balloon-for-cad-in-brazil","status":"publish","type":"post","link":"https:\/\/prevalentindia.in\/index.php\/2025\/09\/17\/anvisa-grants-commercial-approval-to-concept-medicals-magictouch-sirolimus-coated-balloon-for-cad-in-brazil\/","title":{"rendered":"ANVISA Grants Commercial Approval to Concept Medical\u2019s MagicTouch Sirolimus-Coated Balloon for CAD in Brazil"},"content":{"rendered":"<div>\n<p><strong>S\u00e3o Paulo (Brazil), September 17:\u00a0 <a href=\"https:\/\/www.conceptmedical.com\/\" target=\"_blank\" rel=\"noopener\">Concept Medical<\/a> <\/strong>Group, a global leader in drug-delivery technologies, announced that <strong>ANVISA (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria)<\/strong>, Brazil\u2019s Health Surveillance Agency, has granted commercial approval for its flagship\u00a0<strong>MagicTouch, Sirolimus-Coated Balloon (SCB) for CAD treatment<\/strong>. This milestone enables patients to access across Brazil in Latin America, offering a new pathway for managing cardiovascular disease.<\/p>\n<p>The\u00a0<strong>approval enables commercial sales in Brazil<\/strong>, strengthening\u00a0<strong>Concept Medical\u2019s<\/strong>\u00a0global footprint and advancing its mission to deliver safer, more effective treatment alternatives. The company is also undergoing ANVISA\u2019s approval process for its wider DCB and DES portfolio, building on its robust clinical trial foundation.<\/p>\n<p>MagicTouch is now the\u00a0<strong>first and only ANVISA-approved sirolimus-coated balloon in Brazil for CAD<\/strong>. This positions Concept Medical at the forefront of drug-delivery innovation, breaking market limitations tied to PCBs or DES. It differentiates the company in a space long dominated by DES players, providing physicians and patients with a metal-free option that delivers sirolimus directly to the vessel wall, thereby reducing restenosis risk and improving long-term outcomes.<\/p>\n<p><strong>Prof. Dr Alexandre Abizaid<\/strong>, Director, Interventional Cardiology, Instituto do Cora\u00e7\u00e3o at S\u00e3o Paulo, commented:<\/p>\n<p><em>\u201cGreat news to hear that ANVISA has approved the use of the first Sirolimus Coated Balloon, MagicTouch, in Brazil. Backed by robust clinical trials and innovative technology, MagicTouch will surely provide a safer alternative to treat patients with coronary obstructions.\u201d<\/em><\/p>\n<p><strong>Dr Manish Doshi<\/strong>, Founder &amp; MD, Concept Medical Group, added:<\/p>\n<p><em>Latin America bears a high burden of cardiovascular disease as a leading cause of mortality, with nearly half a million PCI procedures annually and Brazil alone accounts for ~200,000, making it the region\u2019s largest market. While DES has long dominated, DCBs are emerging as a strong alternative, driven by demand for safer, metal-free therapies like MagicTouch. We are proud to bring this innovation to patients and physicians in Brazil. ANVISA\u2019s approval marks a milestone for Concept Medical and a turning point for DCB adoption, reinforcing our commitment to advancing safer, more effective therapies worldwide.\u201d<\/em><\/p>\n<p><strong>About Concept Medical<\/strong><\/p>\n<p><strong><a href=\"https:\/\/www.conceptmedical.com\/\" target=\"_blank\" rel=\"noopener\">Concept Medical<\/a><\/strong> is a global leader in innovative drug-delivery platforms for coronary and peripheral interventions. Its flagship\u00a0<strong>MagicTouch is the world\u2019s first commercially available Sirolimus-Coated-Balloon<\/strong>, developed with proprietary\u00a0<strong>Nanolute\u2122<\/strong>\u00a0technology for controlled drug delivery. Unlike stents, it leaves no implant, lowering long-term risks. The company also offers a broad portfolio of DCBs and DES, including\u00a0<strong>Abluminus DES+, a novel sirolimus-eluting stent<\/strong>\u00a0<strong>approved especially for CAD patients with Diabetes and AMI<\/strong>. Collectively, with its presence in over\u00a0<strong>80 Countries<\/strong>, Concept Medical\u2019s technologies have\u00a0<strong>benefited over One Million patients globally<\/strong>.\u00a0<strong>MagicTouch<\/strong>\u00a0holds\u00a0<strong>CE approval<\/strong>,\u00a0<strong>USFDA Breakthrough Device Designation<\/strong>, and\u00a0<strong>five USFDA-IDE approvals<\/strong>\u00a0across coronary and peripheral indications. It is also among the\u00a0<strong>most widely studied SCBs<\/strong>, supported by\u00a0<strong>Concept Medical\u2019s extensive clinical trial program of 45+ trials involving over 24,000 patients globally<\/strong>. This evidence base underscores the company\u2019s commitment to advancing safe &amp; effective therapies for cardiovascular care.<\/p>\n<p><em> If you have any objection to this press release content, kindly contact pr.error.rectification@gmail.com to notify us. We will respond and rectify the situation in the next 24 hours.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>S\u00e3o Paulo (Brazil), September 17:\u00a0 Concept Medical Group, a global leader in drug-delivery technologies, announced that ANVISA (Ag\u00eancia<\/p>\n","protected":false},"author":1,"featured_media":55662,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[76],"tags":[577],"class_list":["post-55661","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health","tag-health"],"_links":{"self":[{"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/posts\/55661","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/comments?post=55661"}],"version-history":[{"count":0,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/posts\/55661\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/media\/55662"}],"wp:attachment":[{"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/media?parent=55661"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/categories?post=55661"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/prevalentindia.in\/index.php\/wp-json\/wp\/v2\/tags?post=55661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}