{"id":56132,"date":"2026-09-25T16:47:20","date_gmt":"2026-09-25T11:17:20","guid":{"rendered":"https:\/\/dailynewsindia.co.in\/index.php\/2026\/09\/25\/selution-slr-deb-wins-us-fda-approval-for-in-stent-restenosis-cofounder-amit-bohora-calls-it-a-defining-milestone-for-stentless-cardiac-care\/"},"modified":"2026-09-25T16:47:20","modified_gmt":"2026-09-25T11:17:20","slug":"selution-slr-deb-wins-us-fda-approval-for-in-stent-restenosis-cofounder-amit-bohora-calls-it-a-defining-milestone-for-stentless-cardiac-care","status":"publish","type":"post","link":"https:\/\/dailynewsindia.co.in\/index.php\/2026\/09\/25\/selution-slr-deb-wins-us-fda-approval-for-in-stent-restenosis-cofounder-amit-bohora-calls-it-a-defining-milestone-for-stentless-cardiac-care\/","title":{"rendered":"SELUTION SLR\u2122 DEB Wins US FDA Approval for In-Stent Restenosis \u2013 Cofounder Amit Bohora Calls It \u201cA Defining Milestone for Stentless Cardiac Care\u201d"},"content":{"rendered":"
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The technology Amit Bohora co-founded at MedAlliance, and later sold to Cordis in a landmark USD 1.135 Billion deal, has just become the first and only sirolimus drug-eluting balloon approved in the United States<\/em><\/p>\n

San Francisco [USA], September 25: <\/strong>The U.S. Food and Drug Administration has approved the SELUTION SLR\"\u2122\" (Sustained Limus Release) Drug-Eluting Balloon for coronary in-stent restenosis (ISR), Cordis announced this month \u2013\u00a0 making it the first and only sirolimus drug-eluting balloon approved for use anywhere in the United States. For Amit Bohora, who co-founded MedAlliance and helped take SELUTION SLR from an early research concept to a globally commercialized therapy before the company was acquired by Cordis in October 2023 for USD 1.135 Billion, the approval is a personal milestone in a technology he spent over a decade building.<\/p>\n

It has taken more than a decade, thousands of patients, and one of medtech\u2019s biggest recent exits to get here. This week, it became history.<\/strong><\/p>\n

A Milestone Years in the Making<\/h2>\n

The approval rests on the SELUTION4ISR trial, a multicenter, randomized study of more than 400 patients across 48 sites in the United States, Canada, Brazil and Europe, which met its primary endpoint of non-inferiority against standard-of-care treatment at 12 months. It adds to a clinical evidence base that now spans more than 5,000 patients worldwide \u2014 and lands just as Cordis confirms it has completed enrollment in a 960-patient U.S. trial evaluating the balloon for de novo lesions in small coronary vessels, setting up a second FDA filing to come.<\/p>\n

The U.S. performs close to one million percutaneous coronary interventions a year, and roughly one in ten of those cases involves treating in-stent restenosis \u2014 an artery re-narrowing inside a previous stent. Until now, U.S. physicians reaching for a drug-coated balloon in these cases had only a paclitaxel-based option. SELUTION SLR changes that calculus, becoming the first sirolimus-based alternative available in the country.<\/p>\n

\u201cThis Is What We Set Out to Do\u201d<\/h2>\n

Reflecting on the technology, Amit Bohora said:<\/p>\n

\u201cWhen we set out to build SELUTION at MedAlliance, the goal was never simply to create another device \u2013 it was to give physicians a genuine, stentless alternative for patients living with coronary artery disease. Seeing the therapy now approved by the USFDA for in-stent restenosis, one of the toughest problems in interventional cardiology, is an incredibly proud moment. It validates years of research, clinical trial work, and the conviction that sustained sirolimus release, without a permanent implant, could change how physicians think about re-treating a narrowed artery.\u201d<\/em><\/p>\n

Mr. Bohora, who led MedAlliance\u2019s clinical programs, regulatory approvals and global expansion during his time with the company \u2013 including building out R&D facilities in Switzerland and Singapore and manufacturing capability in the United States \u2013 added:<\/p>\n

\u201cWhat began as a contrarian conviction that cardiology must break free from permanent metal \u2013 has earned the world\u2019s most rigorous regulatory validation. U.S. FDA approval is not just a commercial win; it is a clinical victory for millions living with coronary artery disease.<\/em><\/h2>\n

When we built MedAlliance, we aimed to prove that visionary entrepreneurship, rooted in deep science, can redefine global healthcare. Our USD 1.135Billion acquisition by Cordis amplified that mission. Seeing SELUTION SLR\"\u2122\" unlock the U.S. market proves that transformative Indian leadership and global innovation can forever change the paradigm of cardiovascular care.\u201d<\/em><\/h2>\n

Clinical Perspective: Dr. Praveen Chandra, Principal Investigator, SELUTION First-in-Man Trial<\/h2>\n

\u201cLeading the First-in-Human clinical trial for SELUTION, I witnessed early on how sustained sirolimus delivery could fundamentally alter vascular healing without adding more metal. This FDA approval is a historic vindication of that science. It reflects Amit\u2019s uncompromising dedication to translational clinical rigor, turning a bold idea into a therapy now transforming lives across the globe.\u201d<\/p>\n

Why This Matters<\/h2>\n

SELUTION SLR is now the only sirolimus drug-eluting balloon on the U.S. market \u2014 a category the MedAlliance team, under Mr. Bohora\u2019s leadership, effectively created years before the science was proven at this scale. Commercially available in more than 65 countries and used to treat over 250,000 patients worldwide, the device\u2019s U.S. clearance under its current owner, Cordis, marks a milestone few medtech founders ever get to see: an invention they helped originate becoming standard of care in the world\u2019s most demanding regulatory market.<\/p>\n

About Amit Bohora<\/h2>\n

Amit Bohora is the co-founder of MedAlliance, the Swiss medical technology company that originally developed the SELUTION SLR Drug-Eluting Balloon. He led the company\u2019s journey from early-stage research through worldwide commercialization \u2013 spearheading its clinical, regulatory and manufacturing expansion \u2013 until MedAlliance\u2019s acquisition by Cordis (USA) in October 2023, in a transaction valued at USD 1.135 Billion. Mr. Bohora is not affiliated with Cordis and does not speak on the company\u2019s behalf; this piece reflects his personal perspective as a cofounder on a technology he helped create.<\/p>\n

About SELUTION SLR\"\u2122\" DEB<\/h2>\n

SELUTION SLR\"\u2122\" uses proprietary Sustained Limus Release (SLR) technology, originally developed by MedAlliance, to deliver a controlled release of sirolimus to the vessel wall over roughly 90 days, without leaving a permanent implant behind. With this approval, it becomes the first and only sirolimus drug-eluting balloon available in the U.S. market. SELUTION SLR is now owned and commercialized by Cordis.<\/p>\n

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The technology Amit Bohora co-founded at MedAlliance, and later sold to Cordis in a landmark USD 1.135 Billion deal, has just become the first and only sirolimus drug-eluting balloon approved in the United States San Francisco [USA], September 25: The U.S. Food and Drug Administration has approved the SELUTION SLR (Sustained Limus Release) Drug-Eluting Balloon…<\/p>\n

Read More “SELUTION SLR\u2122 DEB Wins US FDA Approval for In-Stent Restenosis \u2013 Cofounder Amit Bohora Calls It \u201cA Defining Milestone for Stentless Cardiac Care\u201d”<\/span> »<\/a><\/p>\n","protected":false},"author":1,"featured_media":56133,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[54],"class_list":["post-56132","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","tag-business"],"_links":{"self":[{"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/posts\/56132","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/comments?post=56132"}],"version-history":[{"count":0,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/posts\/56132\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/media\/56133"}],"wp:attachment":[{"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/media?parent=56132"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/categories?post=56132"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dailynewsindia.co.in\/index.php\/wp-json\/wp\/v2\/tags?post=56132"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}