Archive · 25 Sep 2026
FDA Approves SELUTION SLR Balloon for Coronary In-Stent Restenosis
The FDA approved a medical balloon called SELUTION SLR for arteries that narrow again inside an existing stent.
This problem is called in-stent restenosis.
The balloon delivers a medicine called sirolimus to the artery wall.
The medicine is released over about 90 days.
The balloon does not leave another permanent implant behind.
A study of more than 400 people found that the treatment performed no worse than the standard treatment after one year.
The device was originally developed by MedAlliance and is now owned and commercialized by Cordis.
Amit Bohora, a MedAlliance cofounder, described the approval as an important milestone.
The U.S. Food and Drug Administration approved Cordis’s SELUTION SLR sirolimus drug-eluting balloon for coronary in-stent restenosis.
The SELUTION4ISR randomized trial involved more than 400 patients at 48 sites and met its 12-month non-inferiority endpoint against standard treatment.
SELUTION SLR is described as the first and only sirolimus drug-eluting balloon approved for use in the United States.
The balloon delivers sirolimus to the vessel wall over roughly 90 days without leaving a permanent implant.
Cordis has completed enrollment in a separate 960-patient U.S. trial involving small coronary vessels, which could support a future FDA filing.
- Who
- The U.S. Food and Drug Administration, Cordis, MedAlliance cofounder Amit Bohora, and patients with coronary in-stent restenosis.
- What
- The FDA approved SELUTION SLR, a sirolimus drug-eluting balloon, for treating coronary in-stent restenosis.
- When
- The approval was announced on September 25, 2026; the supporting trial evaluated outcomes at 12 months.
- Where
- The approval applies to the United States; the supporting trial was conducted at 48 sites in the United States, Canada, Brazil, and Europe.
- Why
- The device is intended to treat artery re-narrowing inside a previous stent while delivering sirolimus without leaving another permanent implant.
- Device
- SELUTION SLR Sustained Limus Release Drug-Eluting Balloon
- Approved use
- Coronary in-stent restenosis
- Regulator
- U.S. Food and Drug Administration
- Clinical evidence
- SELUTION4ISR randomized, multicenter trial involving more than 400 patients across 48 sites
- Trial result
- Met its primary 12-month non-inferiority endpoint against standard-of-care treatment
- Drug delivery
- Sirolimus released to the vessel wall over roughly 90 days
- Current owner
- Cordis
