FDA approves first sirolimus drug-eluting balloon for in-stent restenosis

The US Food and Drug Administration has approved Cordis’ SELUTION SLR™ drug-eluting balloon for coronary in-stent restenosis (ISR), marking the first sirolimus-based device cleared for this indication. The company announced the milestone earlier this month, positioning the product as the only sustained-release sirolimus-eluting balloon available in the US for ISR, a condition where previously placed stents re-narrow due to tissue regrowth.

Drug-eluting balloons have long been used in Europe and other markets, but US adoption has lagged, partly due to regulatory hurdles and the dominance of drug-eluting stents. This approval could shift that dynamic, offering physicians an alternative to repeat stenting or balloon angioplasty alone. The SELUTION SLR™ uses a proprietary micro-reservoir technology to deliver sirolimus over months, a design intended to reduce restenosis rates compared to shorter-acting options.

The approval comes as the company seeks to reassert itself in the coronary device market after years of industry consolidation. It has faced stiff competition from established players in the space, which have historically dominated the drug-eluting stent market. Whether this clearance translates into commercial traction remains an open question—earlier drug-eluting balloons have struggled to gain significant US market share despite their success in other regions.

For now, the FDA’s decision removes a key regulatory barrier. Clinicians may now evaluate whether the sustained-release mechanism offers meaningful clinical benefits over existing options. Investors and competitors will be watching the company’s next moves, including pricing, reimbursement strategies, and any post-market studies the FDA may require.

Sources: yourstory.com