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News
A new stent-free option just landed for heart patients. The FDA has approved the Selution SLR, the first sirolimus-eluting balloon in the U.S. for treating coronary in-stent restenosis. The device delivers sustained drug release for up to 90 days — no permanent implant required — giving interventional cardiologists a fresh tool to tackle repeat blockages.
A new stent-free option just landed for heart patients. The FDA has approved the Selution SLR (Cordis), the first sirolimus-eluting drug-eluting balloon in the U.S. for treating coronary in-stent restenosis — a condition where a previously placed stent becomes blocked again. The device is designed to deliver sustained sirolimus release for up to 90 days without leaving behind a permanent implant, potentially reducing the burden of repeat procedures for patients.
The approval is backed by the SELUTION4ISR trial, a prospective, multicenter, randomized study that compared the balloon against standard of care in 418 patients. The Selution SLR met its primary endpoint of noninferiority for 1-year target vessel failure, with no meaningful differences in safety or secondary outcomes, including all-cause mortality.
By the Numbers:
Why it matters: In-stent restenosis remains a persistent challenge in interventional cardiology. With the Selution SLR joining the paclitaxel-coated Agent balloon (approved in 2024), clinicians now have two drug-eluting balloon options — expanding treatment choices and offering patients an effective path forward without adding another permanent stent.
