A Milestone Years in the Making
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 — 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.
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 — 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.
“This Is What We Set Out to Do”
Reflecting on the technology, Amit Bohora said:
“When we set out to build SELUTION at MedAlliance, the goal was never simply to create another device – 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.”
Mr. Bohora, who led MedAlliance’s clinical programs, regulatory approvals and global expansion during his time with the company – including building out R&D facilities in Switzerland and Singapore and manufacturing capability in the United States – added:
“What began as a contrarian conviction that cardiology must break free from permanent metal – has earned the world’s 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.
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 unlock the U.S. market proves that transformative Indian leadership and global innovation can forever change the paradigm of cardiovascular care.”
Clinical Perspective: Dr. Praveen Chandra, Principal Investigator, SELUTION First-in-Man Trial
“Leading 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’s uncompromising dedication to translational clinical rigor, turning a bold idea into a therapy now transforming lives across the globe.”
Why This Matters
SELUTION SLR is now the only sirolimus drug-eluting balloon on the U.S. market — a category the MedAlliance team, under Mr. Bohora’s 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’s 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’s most demanding regulatory market.
About Amit Bohora
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’s journey from early-stage research through worldwide commercialization – spearheading its clinical, regulatory and manufacturing expansion – until MedAlliance’s 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’s behalf; this piece reflects his personal perspective as a cofounder on a technology he helped create.
About SELUTION SLR DEB
SELUTION SLR 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.
