Cordis Wins FDA Nod for First US Sirolimus Balloon

The US Food and Drug Administration (FDA) has approved Cordis’ Selution SLR sirolimus-eluting balloon for the treatment of coronary in-stent restenosis (ISR). Announced on 22 September 2026, the device is the first sirolimus-coated balloon approved in the US and provides physicians an alternative to uncoated balloons and Boston Scientific’s paclitaxel-coated Agent device, directly opening a new competitive front in the interventional cardiology drug-eluting balloon category.

Selution SLR is an angioplasty balloon catheter coated with the drug sirolimus, addressing ISR, a condition in which stented coronary artery lesions narrow after initial treatment. US guidelines recognise repeat stenting as the most effective treatment, but layering additional stents raises the risk of cardiovascular adverse events. Selution SLR’s launch is supported by clinical data showing non-inferiority to a usual care control strategy including 80% repeat drug-eluting stents. Target lesion failure rates in all randomised patients were 15.2% for Selution SLR versus 13.5% for standard of care, meeting the primary non-inferiority endpoint, although the trial missed a secondary endpoint in single-layer ISR patients (14.2% versus 6.5%).

Cordis has given US physicians immediate access to Selution SLR. The approval delivers a strategic win for Cordis, following its $235 million acquisition of Swiss drug-eluting balloon developer MedAlliance in 2023. Cordis is now owned by private equity firm Hellman & Friedman, having previously been divested by J&J to Cardinal Health (2015) and then to H&F (2021). The launch places Cordis in direct competition with Boston Scientific’s Agent, a key driver of Boston Scientific’s first-half 2026 cardiovascular franchise growth, and with Concept Medical’s Magic Touch and B. Braun’s SeQuent SCB in Europe.

The commercial signal is a rapidly evolving drug-eluting balloon category where sirolimus challenges paclitaxel dominance, opening a substantive competitive front in interventional cardiology. Repeat stent burden economics drive commercial urgency. Expect Boston Scientific (Agent), Concept Medical (Magic Touch), B. Braun (SeQuent SCB), Medtronic and Abbott to sharpen their positioning across drug-coated balloons and stent-alternative approaches through the rest of 2026 and 2027.

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