FDA Approves Cordis's SELUTION SLR Balloon Developed by MedAlliance Founder Amit Bohora

6 Oct 2026, 5:36 pm · 2h ago · 1 min read · YourStoryNew

The US Food and Drug Administration has approved Cordis’s SELUTION SLR Drug-Eluting Balloon for treating coronary in-stent restenosis. It becomes the first sirolimus-eluting balloon authorized for this indication in the United States. The underlying technology was co-founded by Indian entrepreneur Amit Bohora at MedAlliance, which Cordis acquired in October 2023 for $1.135 billion. Approval follows the SELUTION4ISR trial across 48 international sites, demonstrating non-inferiority against standard-of-care treatments at 12 months. Cordis has also finished enrollment for a 960-patient US trial evaluating the device for small coronary vessel lesions ahead of further filings.