The US Food and Drug Administration has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon for coronary in-stent restenosis (ISR), Cordis announced this month. This is 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 $1.135 billion, the approval is a personal milestone in a technology he spent over a decade building.

It took more than a decade, thousands of patients, and one of medtech’s biggest recent exits to get here. 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 US trial evaluating the balloon for de novo lesions in small coronary vessels, setting up a second FDA filing to come.

The US performs close to one million percutaneous coronary interventions a year, and roughly one in 10 of those cases involves treating in-stent restenosis, an artery re-narrowing inside a previous stent.

Until now, US physicians reaching for a drug-coated balloon in these cases had only a paclitaxel-based option.

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