SELUTION SLR™ wins historic US FDA nod for in‑stent restenosis

The US Food and Drug Administration has given its approval to SELUTION SLR™, a Drug-Eluting Balloon for coronary in-stent restenosis (ISR). This is the first sirolimus drug-eluting balloon approved for use in the United States. The approval was based on the SELUTION4ISR trial, a large-scale study involving more than 400 patients across multiple countries, which demonstrated non-inferiority against standard-of-care treatment at 12 months.

This milestone marks a decade-long effort, thousands of patients, and one of medtech's largest exits. Until now, US physicians treating in-stent restenosis only had a paclitaxel-based option, but SELUTION SLR introduces a sirolimus-based alternative. The technology's creator, co-founder Amit Bohora, sees this FDA approval as a personal and professional milestone, validating years of research and clinical trial work.

It also reflects the company's mission to offer a stentless alternative for patients with coronary artery disease. SELUTION SLR is now the only sirolimus drug-eluting balloon in the US market, a significant achievement for the MedAlliance team led by Bohora.