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Cordis received U.S. Food and Drug Administration approval this week for its SELUTION SLR (Sustained Limus Release) drug-eluting balloon for coronary in-stent restenosis (ISR) — the first and only sirolimus-based drug-eluting balloon cleared for use in the United States. The device also carries FDA Breakthrough Device designation, a first for Cordis in this category since it introduced America’s first sirolimus drug-eluting stent in 2003.
What happened
The approval covers treatment of coronary ISR — the re-narrowing of an artery inside a previously implanted stent — without leaving another permanent implant behind. The balloon delivers sirolimus directly into the vessel wall for up to 90 days to prevent recurrence. Until now, U.S. physicians reaching for a drug-coated balloon in these cases had only a paclitaxel-based option, so SELUTION SLR introduces the first sirolimus alternative on the American market.
The decision rests on the SELUTION4ISR trial, a prospective, multicenter, randomized, single-blind noninferiority study of more than 400 patients across 48 sites in the United States, Canada, Brazil and Europe. It compared SELUTION SLR against standard of care — drug-eluting stents in about 80% of control cases — and met its primary endpoint at 12 months, with target lesion failure of 15.2% for SELUTION SLR versus 13.5% for standard care. The device is already commercial in more than 65 countries and has been used in over 250,000 patients worldwide.
Why it matters
The U.S. performs close to one million percutaneous coronary interventions a year, and roughly one in ten involves treating in-stent restenosis. For that ~100,000-procedure slice, the stentless approach matters: implanting another stent inside a failed stent is often a poor answer, and a balloon that delivers therapy and disappears preserves future treatment options. Cardiology has been moving toward “leave nothing behind” strategies for years, and this approval gives U.S. operators a sirolimus-based tool for the first time — notable because sirolimus has a different safety and efficacy profile from paclitaxel, the previous balloon-only option.
From a market standpoint, the launch risk looks contained: this is not an untested device but one with a 65-country installed base, a decade of development, and a $1.135 billion acquisition of original developer MedAlliance by Cordis in 2023 backing its credibility.
What to watch
First, the commercial ramp: hospital adoption timelines and payer coverage decisions will determine how fast SELUTION SLR takes share from repeat-stent procedures and paclitaxel balloons. Second, Cordis says it has completed enrollment in a 960-patient U.S. trial evaluating the balloon for de novo lesions in small coronary vessels — a potential second FDA filing that would materially expand the addressable market beyond ISR. Third, watch the competitive response from the incumbent drug-eluting stent franchises.
Related reading: Mirum’s Atebrioz Wins FDA Approval for Ultra-Rare FOP Bone Disorder · FDA Approves Merck Welireg + Lenvima Combo for Kidney Cancer
Sources: Hospimedica · G-Medtech
Auto-posted by the Bull Lounge news desk.
Not financial advice.
Do you think the stentless approach will become the standard for repeat coronary procedures, or will drug-eluting stents keep their dominance?
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