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News
The FDA has approved Cordis's Selution SLR sirolimus-eluting balloon for treating coronary in-stent restenosis (ISR), making it the second drug-coated balloon available to US operators. The approval is backed by the SELUTION4ISR trial, which showed the device was noninferior to standard of care at one year. It joins Boston Scientific's Agent paclitaxel-coated balloon, which received FDA approval for the same indication in March 2024.
The FDA has approved Cordis's Selution SLR sirolimus-eluting balloon for the treatment of coronary in-stent restenosis (ISR), giving US interventional cardiologists a second drug-coated balloon (DCB) option. The Selution SLR is the first sirolimus-based DCB approved for this indication and joins Boston Scientific's Agent paclitaxel-coated balloon, which entered the US market in March 2024.
The approval is grounded in results from the SELUTION4ISR trial, which demonstrated that the device was noninferior to standard-of-care treatments — primarily drug-eluting stents, with 20% plain balloon angioplasty — for target lesion failure at one year. Cordis also announced completion of enrollment in the 960-patient SELUTION4DeNovo IDE trial, evaluating the balloon for de novo lesions in small coronary vessels — a potential future expansion of its US indication.
By the Numbers:
Why it matters: Expanding the DCB toolkit for ISR gives clinicians more flexibility in managing a challenging condition, particularly for patients who may benefit from a stent-free approach. The addition of a sirolimus-based option alongside the existing paclitaxel-based balloon broadens treatment choices and may inform future comparative effectiveness research.
