FDA approves SELUTION SLR sirolimus drug-eluting balloon for coronary in-stent restenosis
The FDA has approved Cordis' SELUTION SLR sirolimus drug-eluting balloon for treatment of coronary in-stent restenosis, making it the first sirolimus drug-eluting balloon available in the United States.
The device delivers sustained sirolimus therapy to the vessel wall without leaving another permanent implant behind, providing a new interventional option for patients whose coronary stents have narrowed again.
The approval expands the US coronary intervention toolkit and introduces a different drug-delivery approach for treating in-stent restenosis.
Field | Content |
Alert Type | Approval |
Device Name | SELUTION SLR |
Company | Cordis |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Medical device approval |
Indication | Treatment of coronary in-stent restenosis |
Therapy Area(s) | Cardiology; interventional cardiology |
Technology or Modality | Sirolimus drug-eluting balloon |
Geography | United States |
What Happened | The FDA approved Cordis' SELUTION SLR drug-eluting balloon for coronary in-stent restenosis. |
Why It Matters | SELUTION SLR is the first sirolimus drug-eluting balloon approved in the US and provides drug delivery without implanting an additional permanent stent. |
Supporting Context | In-stent restenosis occurs when treated coronary arteries narrow again after stent implantation and may require repeat intervention. |
Potential Impact | The device could give interventional cardiologists another treatment option for restenosis while reducing the need for additional metal implants. |
Key Takeaway | SELUTION SLR becomes the first FDA-approved sirolimus drug-eluting balloon for coronary in-stent restenosis in the US. |
What to Watch | US commercial rollout, adoption in catheterisation laboratories and real-world outcomes compared with repeat stenting and other balloon technologies. |
Primary Source | Cordis |
Relevant Date | 21 September 2026 |
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